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Remote Data Capture:Acquisition and AnalysiseClinical Visions

HEALTH SCIENCES

Contents:

Trends and Issues in an Electronic Clinical Data Management WorldPatti Devereux Gaves and Alastair Clewlow, Oracle Health Sciences

State-of-the-Science—The New Remote Data Capture ParadigmRobert R Goodwin, Pfizer, Inc.

Improving and Monitoring Clinical DataManagement in the eClinical AgeJames Streeter, PPD, Inc.

Optimizing and Supporting Remote Data CaptureDave Hanaman and Rob Vollkommer, C3i, Inc.

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ECLINICAL VISIONSREMOTE DATA CAPTURE:ACQUISITION AND ANALYSIS

HEALTH SCIENCES

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Trends and Issues in an Electronic Clinical Data Management World 3Patti Devereux Gaves1 and Alastair Clewlow2

1. Senior Director, Life Sciences Product Strategy; 2. Director, Product Strategy for

Clinical Data Management, Oracle Health Sciences

State-of-the-Science—The New Remote Data Capture Paradigm 6Robert R Goodwin

Vice President, Global Clinical Data Services, Pfizer, Inc.

Improving and Monitoring Clinical Data Management in the eClinical Age 9James Streeter

Executive Director, Electronic Data Capture, PPD, Inc.

Optimizing and Supporting Remote Data Capture 13Dave Hanaman1 and Rob Vollkommer2

1. Executive Vice President and Co-Founder; 2. Vice President, Clinical Services, C3i, Inc.

eClinical Visions

Introduction

Contents

ECLINICAL VISIONSREMOTE DATA CAPTURE:ACQUISITION AND ANALYSIS

© T O U C H B R I E F I N G S 2 0 0 92

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3© T O U C H B R I E F I N G S 2 0 0 9

Trends and Issues in an Electronic Clinical Data Management World

a report by

Patt i Devereux Gaves 1 and Alastair C lewlow 2

1. Senior Director, Life Sciences Product Strategy; 2. Director, Product Strategy for Clinical Data Management, Oracle Health Sciences

Over the last 15 years, Internet and eTechnologies have become an

integral part of everyday business in most sectors, but have taken time

to gain traction in the clinical trials arena. Now, as the industry faces

unprecedented challenges and further consolidation, companies are

increasingly embracing technology as a lever to differentiate themselves,

boost productivity, and succeed in the new environment.

The Internet, Pharma, and Electronic Data Capture

In the pharmaceutical industry, the emergence and acceptance of

Internet-enabled technologies such as electronic data capture (EDC)

have transformed clinical development practices, efficiently supporting

faster, larger, and more complex trials.

Current industry projections estimate that EDC is now used in

approximately 50% of all clinical trials (see Figure 1).1 Companies are

increasingly leveraging EDC and other tools to power global trials and

benefit from the ability to analyze incoming data and performance

metrics in real time. The availability of such data supports more rapid

decision-making and provides the agility to make necessary

adjustments during ongoing trials.

With increased adoption of EDC, market expectations for the

technology are high. A more technology-fluent user base is

demanding richer features, ease of use, and flexibility within trial

settings. Global usage also requires high availability and scalability.

Furthermore, there is a growing acknowledgement that EDC

represents only a subset of the critical aspects of the overall data value

chain, highlighting the need for a fully integrated eClinical ecosystem.

Such an integration of EDC and other eClinical systems will provide a

holistic view across trials and data sources and minimize process and

infrastructure redundancies.

In this dynamic environment, EDC and other clinical trial technologies

can deliver real fundamental benefits but also continue to introduce

new challenges as the eClinical evolution continues. Some of these

issues are discussed below.

Changing Roles for Data Management

Data management organizations in particular are front and center in

this bold new world. Due to the increasingly prevalent use of EDC

coupled with industry outsourcing trends, the role of an ‘in-house’

data manager has changed considerably. Further removed from the

daily discrepancy resolution routine, these individuals are now charged

with program-level oversight responsibilities, including tracking

progress of work being conducted by third-party contract research

organizations (CROs), and sometimes across multiple organizations on

several studies. While skills in the core data management systems are

still vital, better tools are necessary to provide oversight-level data in

real time, and productivity and performance metrics are paramount to

understanding and measuring this new environment.

Globalization and New Challenges

While ongoing global expansion of trials presents new opportunities,

it additionally increases the pressure and demands placed on EDC and

IT infrastructure and support resources. The growing prevalence of

global site users and outsourcing practices have transformed clinical

trials into an around-the-clock operation. This ‘always on’ business

model creates a technical support dilemma. Given the 24/7 availability

requirements to support the global trial environment, there is no

opportune time to schedule maintenance and perform repairs.


Alastair Clewlow is Director of Product Strategy forClinical Data Management in the Oracle Health SciencesGlobal Business Unit. He has 12 years of experience in thepharmaceutical industry, beginning as a Data Manager at LEO Pharma before becoming a Clinical ResearchAssociate. Mr Clewlow relocated to Denmark in 2000 toimplement a clinical trial management system, beforebecoming Head of the Clinical Data and DocumentManagement Department, with responsibility for clinical

data management, clinical and safety systems support, and management of clinical trialdocumentation. He graduated from the University of Portsmouth with a BSc (Hons) inmolecular biology.


Patti Devereux Gaves is Senior Director of Life SciencesProduct Strategy for Oracle’s Health Sciences GlobalBusiness Unit. She returned to Oracle in June 2008 fromPfizer, where she held the positions of Senior Director,Technical Operations in Global Clinical Data Services, andDirector of Patient Data Systems in DevelopmentInformatics. She has more than 15 years of clinical datamanagement and related technology experience, andspent five years in Oracle’s clinical consulting group

leading customer implementations and delivery teams, as well as several years in datamanagement at Parke-Davis. Ms Gaves holds a BSc from Eastern Michigan University andan MA from the University of Michigan.


A more technology-fluent user base is

demanding richer features, ease of use,

and flexibility within trial settings.

Clewlow_new.qxp 12/5/09 4:16 pm Page 3

Furthermore, in the event that a technical problem that affects EDC

system availability does occur, all sites using the technology platform

can potentially be affected. For example, a pharmaceutical company

running 300 trials concurrently might, in the worst-case scenario, have

to suspend workflow on all trials until access to the system can be

restored. Given the staggering implications of this example, companies

are focusing on issues such as infrastructure/server redundancy,

backups, and failover. With EDC, there is an absolute dependency on

IT support and service levels to ensure business continuity running

clinical trials. This reality has been an internal hurdle for some

organizations seeking to implement EDC, and some organizations

have opted to outsource.

Similarly, since EDC use extends to site staff as well as CROs and

business process outsourcing providers, the exponential growth of

user populations has led many organizations to rethink their

EDC support strategies. Both end-user training and ongoing helpdesk

support is critical to success with EDC. Vendors are coming into this

space specifically to handle initial training, arrange Internet

connectivity around the world, negotiate Internet service provider

agreements, provision and track hardware when necessary, and

provide all-hours helpdesk services in multiple languages.

Trial Complexity

Trials have evolved significantly over the past several years. Historically,

the traditional trial model followed a natural, sequential pattern in

which companies would collect data over the course of the trial, and

when completed would lock the database, carry out analyses, and

assemble a candidate submission. Clinical trials today, however, are

much more complex. The advent of EDC enables much earlier data

review, and it has also helped advance new trial designs that rely on

such early data availability. Instead of a single analysis after the trial

completes, trials today require multiple sophisticated data cuts and

ongoing analyses. Availability of data from EDC helps to facilitate such

‘soft-lock’ processes, effectively simulating a subset of the traditional

end-of-study procedures with interim data.

This mid-study process can occur multiple times during the trial for

safety monitoring boards, submissions, or interim reviews. However,

utilizing this sort of rolling lock system consumes more resources than

the traditional process. So, while EDC enables resource savings for

traditional discrepancy management activities (as projected), this trend

for more complex trials and process changes introduces added

complexity and new resource demands to support a study.

The use of adaptive trials is also increasing, which requires support for

real-time insights and a variety of mid-trial modifications for dynamic

response to changing circumstances.

Complex trials are also being leveraged strategically to optimize

resources and productivity given the constrained financial climate,

budget cuts, and pressure to run fewer trial programs. To meet trial

quotas while fulfilling project needs, companies can opt to run

multiple studies within a single trial. For example, within a single

oncology trial, there may be six separate study populations each based

on a different tumor type.

4 E C L I N I C A L V I S I O N S


Figure 1: US Electronic Data Capture Adoption

80

70

60

50

40

30

20

10

0

12

10

8

6

4

2

0

Perc

enta

ge o

f tria

ls u

sing

EDC Acceleration in grow

th (%)

2003 2004

New EDC trials (phase I–III)

2005 2006 2007 2008 2009 2010 2011 2012

Acceleration in growth

Source: Adapted from Health Industry Insights, 2008.1

The advent of EDC enables much

earlier data review, and it has also

helped advance new trial designs that

rely on such early data availability.

Complex trials are also being leveraged

strategically to optimize resources and

productivity given the constrained

financial climate, budget cuts, and

pressure to run fewer trial programs.


Data Integration and Interoperability

EDC is just one aspect of the eClinical ecosystem. There are many

systems employed throughout the clinical development process for

data acquisition, data analysis, trial management, and reporting. As

the volume of data from all sources increases, the need for an

intelligent aggregate data storage environment becomes imperative.

Oracle has introduced one such system, the Life Sciences Data Hub,

that enables access to all trial data from a single location, thus greatly

reducing the time and effort required for study reporting milestones

while providing the ability to accurately track and reconstruct

complete reporting data sets and outputs.

While there are a multitude of available software platforms designed

to manage various aspects of clinical trials, most of these disparate

systems work independently of one another, unable to communicate

or share information. Additionally, sponsor companies may use

separate, independent vendors for each IT system, particularly if they

seek to employ ‘best-of-breed’ options for every product type. When

overlap does exist between applications but identical data must be

entered into them independently, the issues of redundancy and

inefficient use of both time and resources are compounded.

Going forward, interoperability will be a key factor in realizing

maximum possible results using eClinical systems, allowing records to

be linked and shared, and eventually improving efficiency and

reducing overall costs. Industry standards will evolve to make disparate

platforms interoperable and less proprietary. Oracle is working toward

this objective by developing the Health Sciences Suite platform, a fully

integrated suite of best-in-breed eClinical applications that will also be

able to extend to applications from other vendors.

The Road Ahead

The industry is changing more rapidly than ever before and

organizations across the pharmaceutical spectrum are dealing with

many of the issues discussed herein. This report features contributions

from leaders of some of the organizations working at the forefront of

the EDC movement. These authors describe their organizations’

experiences of working with Oracle’s EDC solution, Remote Data

Capture (RDC), and provide insights into related challenges, successes,

and lessons learned.

Robert Goodwin, Pfizer

As the world’s largest pharmaceutical company, the way in which Pfizer

implements and handles the running of full-scale EDC will be a

touchstone for other companies in the industry. Robert Goodwin, Vice

President of Global Clinical Data Services, talks about the role of

technology when working with many different kinds of partners,

including investigators, technology vendors, and CROs, in collaborating

to run complex, global clinical trials.

James Streeter, PPD

The CRO is now a critical link enabling pharmaceutical firms to run

large, intricate clinical trials as efficiently as possible in many locations

around the world. James Streeter, Executive Director of EDC, talks

about the pressures on a CRO to ensure that staff are properly trained

and supported to keep pace with the high-pressure, fast-moving

clinical trial environment.

Dave Hanaman and Rob Vollkommer, C3i

Technology is the enabler, but who empowers people to use it? Step

forward technology service company C3i, which works to ensure that

clinical trial staff have access to the right equipment when they require

it, have the requisite knowledge to get the most out of it, and have

support on hand for when they need it.

We extend our sincere appreciation to our contributors for sharing

their valuable insights and experiences in this report. The eClinical

transformation offers a chance to maximize the value of clinical trials,

improving pharmaceutical development efficiencies and ultimately

providing patients with timely, new, and improved treatment options.

We have seen significant progress to date and tremendous

opportunities lie ahead. Companies of all types and sizes must respond

to the pressures the industry is facing, trim operating expenses, and

establish cost-effective and efficient working practices. It is critical to

weigh technology investments against both short- and long-term

objectives. Oracle is committed to the health sciences market and is

uniquely positioned to deliver a full-spectrum, comprehensive solution.

Although there will be short-term challenges to overcome in the

process of continuously adapting to new technologies and gaining

acceptance of new ways of working, we hope that this report will

resonate with those professionals who are helping to lead the way

through the eClinical landscape toward a complete, open, and

integrated clinical trials ecosystem.

We look forward to your thoughts and feedback. ■

5E C L I N I C A L V I S I O N S


1. Louie A, US Electronic Data Capture 2007–2012 Spending Forecast and Analysis, Health Industry Insights, 2008.

Going forward, interoperability will

be a key factor in realizing maximum

possible results using eClinical systems.

The eClinical transformation offers a

chance to maximize the value of clinical

trials, improving pharmaceutical

development efficiencies and ultimately

providing patients with timely, new, and

improved treatment options.


The perception of ‘big pharma’ used to be that of change-averse,

slow-moving clinical trial leviathans, but that view is now largely

obsolete. Many pharmaceutical firms have slimmed down and

outsourced a lot of their non-core work. Behind the scenes they have

been investigating electronic and remote data capture (EDC/RDC)

technologies, working not only to improve the quality of trials and thus

the data acquired, but also to make the whole process less onerous for

clinical investigators. To this end, Pfizer has been working with Oracle on

improving its RDC offering, ensuring that it can keep up with the

demands of investigators, the rigors of performing global clinical trials,

and the changing economy as a whole.

In many ways, the changing clinical trial environment is only a reflection

of the changes endemic to the rest of the economy. In testing times,

when cash and credit are scarce, it is vital to contain the number of trials

that are being run and remain focused on core areas of interest.

Specifically, in terms of data management, the important facts to

consider are how and where trials are placed. This means working with

investigator sites to make sure that they have the technology needed to

enable them to deliver the data. Technology becomes more important as

an organization’s presence grows worldwide. These days, most of the

data management functions of a pharmaceutical firm are outsourced, so

the other crucial element is how these vendors are managed. From a

regulatory perspective, a pharmaceutical company must be able to prove

it has transparency over the trials and is maintaining effective oversight

to the vendors, as well as obtaining appropriate-quality data.

The Changing Nature of Pharma

As recently as the late 1990s it was the sponsor organization’s

responsibility to set up a trial. A sponsor such as Pfizer would have had

to locate study sites around the world with access to a suitable

population. The sponsor would also be responsible for hiring and training

trial staff and ensuring that they were conducting their work using the

appropriate processes and procedures. However, whereas clinical trials

are critical to the pharmaceutical development process, this sourcing and

resourcing process is not a core competency of a pharmaceutical firm.

Gradually, pharma have moved away from this ‘hands-on’ work and, to

a certain extent, become detached from the market.

In parallel—and almost certainly partly responsible for this trend—

contract research organizations (CROs) have gained an advantage: they

understand the market dynamics, have contacts in low-cost countries,

and have a core competency in staff management. CROs are now the

universal link between the pharmaceutical firm running the trial and

the staff that administrate it. Of course, outsourcing is not a new

phenomenon, but in the last decade it has taken on a new importance

as pharma have grown in size and off-shoring has become the norm.

However, some of the challenges faced by pharmaceutical companies

have changed. Financial pressures—always a challenge for any

business—have taken on a new meaning: now the emphasis has shifted

toward ensuring that the vendors chosen are not only high-quality and

technologically advanced, but also that they have the financial ability to

withstand the ups and downs in the market. This has led to many of the

service and technology providers merging and the market as a whole

consolidating. These new super-vendors now mirror the peaks and

troughs in the primary pharmaceutical market.

Furthermore, price is now no longer the only variable. Pharma are

demanding more efficiencies from their vendors, looking for nimble and

agile companies as well as large or strong ones. In order to eliminate

waste and inefficiencies, many vendors are employing modern

management techniques such as lean manufacturing and six sigma

quality control processes. The whole industry is raising its game.

The Quality Game

Along with expectations and internal processes, the quality of the

relationship between sponsor and vendor has also risen. In nearly all cases

these relationships have moved from being simply a transaction for a

service or technology to a deeper, value-generating partnership with

shared goals and a co-identity—true joint ventures. When a pharma

outsources the bulk of its work, it needs to become intimate with its

suppliers. Even across multiple vendors there is a sharing process; good

ideas usually come from several areas. Each one of the different providers

that are part of the project needs to share that process or that good idea.

In turn, in order to become more efficient suppliers need to have access to

all relevant information; the pharma also needs to share more and properly

trust its partners. In the best examples, this sharing attitude permeates all

organizations that are part of the partnership: staff from those companies

a report by

Robert R Goodwin

Vice President, Global Clinical Data Services, Pfizer, Inc.

State-of-the-Science—The New Remote Data Capture Paradigm

© T O U C H B R I E F I N G S 2 0 0 9

Robert R Goodwin is Vice President of Global Clinical DataServices at Pfizer. In this role, he is responsible for thedelivery of cost-effective and efficient centralized datamanagement activities for Pfizer and for the strategy andexecution of near-shore and off-shoring opportunities. Hehas introduced concepts of lean and six sigma to create amanufacturing mindset for data management, with a focuson cycle times, removing handoffs, and creating repeatabletasks for improved productivity. Mr Goodwin has 20 years of

industry experience in statistics, SAS programming, data management, electronic datacapture, and strategic project management. His previous positions include roles in theacquisition teams concerning the Warner Lambert and Pharmacia acquisitions, withresponsibility for data and processes. Mr Goodwin holds a BSc in psychology from EasternConnecticut State University, an MSc in research, measurement, and evaluation fromSouthern Connecticut State University, and an MBA in pharmaceutical and chemical studies.


State-of-the-Science New RDC Paradigm

6

Pfizer_Goodwin_subbed.qxp 18/5/09 12:28 pm Page 6

sharing their goals have a greater sense of belonging, which in practical

terms translates into more loyalty and a lower staff turnover.

Of course, there are many different outsourcing models. The traditional

one-off single-trial approach where the sponsor company will pay to

receive a data set at the conclusion of the trial is still extant. A sponsor

may take a more strategic attitude and outsource in a certain area or

indication, yet still rely heavily on the CRO and its data management

systems to provide the data sets. The third option is for a sponsor to take

a strategic approach but to employ its own systems and retain more

control over data. Each model has inherent risks and benefits, and will

determine what is required in terms of technology and human resources.

The Pfizer Approach

Pfizer currently outsources its clinical trial activities through a select

group of preferred strategic providers, employing elements from all of

the aforementioned outsourcing models. The choice of model is very

project-specific: in some cases Pfizer uses the traditional full-service CRO

approach, with the CRO as the sole point of contact, while in others it

uses a hybrid model, which is a full-service CRO model using Pfizer

processing systems. The majority of the studies are run within the

Pfizer functional service provider (FSP) model. With the FSP model, unlike

in the traditional full-service model, vendors perform activity-based

services by function and have internal resources dedicated to the

sponsor firm on a full-time basis (see Figure 1). Furthermore, the vendors

use Pfizer processing systems and standard operating procedures.

Securing such a long-term, strategic, and intimate relationship is no

simple matter. Finding the right partners is an important first step. It is

essential that a partner organization share the same philosophies as

Pfizer, particularly from senior management; if there is the right

relationship and work philosophy at the top, this will filter down through

the organization to the rest of the employees. After mutual respect come

the metrics: being able to measure the business, the output, and the

throughput of each of the providers. However, overall, competition

between vendors is no longer about the work to be undertaken or its

price—it is about how an organization distinguishes itself, the ideas it

brings to the table, the quality of the data it provides, and the ease of the

collaborative process and the efficiencies it can permit.

Enabling Technology

In the new partnership paradigm, IT infrastructure becomes very important.

This applies as much to the basics (email, shared calendars, live meetings,

shared documents, etc.) as to the core technology of a trial—the data

capture system. However, while the former is simply a matter of connectivity

and is not process-specific, it is essential that the latter is standardized, and

it is not unusual for a sponsor company to dictate to its vendors which

platform should be used.

Initially, Pfizer developed its own proprietary EDC system, I-Net, which was

developed at a time when there were no dominant EDC vendors in the

market. Over and above simply providing an EDC system, the process of

development and management of I-Net gave Pfizer an insight into the

underlying EDC technology to understand it at a fundamental level and

learn how it works. It was not a completely smooth undertaking

and mistakes were made, which are in many ways more valuable in terms

of the learning curve than the successful decisions and actions. The main

outcomes of the I-Net pilot are that Pfizer learned about working with EDC:

that the IT systems and clinical development processes need to be aligned;

that the information acquired needs to be aggregated at the investigator

site; that any EDC tool used should not require retraining of the whole data

management organization; and that there should not be multiple

environments for paper and EDC. Above all, this pilot showed that the IT

skills required to maintain such a system were beyond what should be

considered the core capabilities of a large pharmaceutical organization.

I-Net was finally retired in 2007, and Oracle RDC is now routinely used

within Pfizer. The transition period was relatively painless as Pfizer

was already using much of the Oracle eClinical suite. Today, all

Pfizer-sponsored clinical trials use Oracle RDC for data capture, and

all Pfizer vendors also use it. This provides consistency regarding the data

sets and how they are processed. For investigator sites, it is a common tool

that they will use every time they participate in a Pfizer trial. For clinical trial

monitors, being able to routinely use and become familiar with a


State-of-the-Science—The New Remote Data Capture Paradigm

It is essential that a partner

organization share the same

philosophies as Pfizer, particularly

from senior management; if there is the

right relationship and work philosophy

at the top, this will filter down through

the organization.

Figure 1: Evolution of the Pfizer Service Model

CRO3 CRO2

CRO1CRO4 CRO5

CRO6CRO4

CRO6

Sponsor

Sponsor

Sponsor

Uncoordinated CRO model

Sponsor

FSP-3 FSP-X

FSP-1

FSP-2

FSP model

CRO = contract research organization; FSP = functional service provider.


standardized toolkit also improves their efficiency and ability to perform. In

fact, it was only the way in which the system was perceived that required a

radical overhaul. Users needed to change their mindset and acknowledge

that Oracle RDC is more than simply a data management tool: it can be used

by many different stakeholders to improve and adapt the trial. Essentially, it

has become an enterprise-type application for clinical trials.

Benefits to Business

The adoption of RDC is more or less complete at Pfizer. When a new clinical

trial is set up, there is no question as to whether it is paper or not; it is

automatically assumed to be RDC. It is now considered to be a mature

technology, and one whose value is measured not by return on investment

(ROI) but by the efficiencies it brings and the new processes it enables.

The clinical testing phase represents approximately 40% of the cost involved

in developing a compound, which in total is measured in hundreds of

millions of dollars. The further through clinical testing a compound

progresses, the larger, more complex, and more expensive the trial

becomes. Therefore, it is always in the sponsor’s best interests to identify the

potential of a compound as early as possible and either commit to or

eliminate it. One way to facilitate identification is by using adaptive clinical

trial designs, where the database is periodically ‘soft-locked’ and the CRO or

sponsor can simulate a final analysis to see whether results are trending in

the right way. In some cases this happens with every patient, every visit

(EPEV)—a continuous cleaning strategy. It is extremely difficult to do this

with a paper-based system, but with RDC it is possible to visualize safety

profiles early on and make decisions about the progress of the trial.

It is not just the technical side of the RDC tool that benefits the

business; it also has a positive impact on human resources, namely

investigators. The Pfizer philosophy is to treat investigators as customers,

and to focus on providing them with the best experience possible. The

investigator pool is limited in size, and all CROs and sponsor companies are

effectively competing for their services. From the investigator point of view,

the interest in a clinical trial lies in the science, and that is what they are set

up to do. The easier and more intuitive the toolset is to handle, and the less

impact it has on the investigator site, the better. A system such as Oracle

RDC, which is Internet-based and therefore has a zero footprint, makes it

easier for the investigator to conduct their business.

Therefore, it is important to consider what investigators and monitors

need over and above purely data entry, for example programming of edit

checks, rethinking screen design, and access to more detailed information.

Investigators’ feedback on the case report forms (CRFs), technology used,

instructions, and response to queries and other items is a valuable input

that is used to improve the experience of working for Pfizer. Pfizer used

this information as part of the development process for the latest version

of Oracle RDC 4.5.3. Other companies also contributed to the upgrade,

which not only improves the software but also ensures that the platform

is more generalized, so the training overhead that any one sponsor needs

to provide when using RDC is already reduced. As more companies adopt

the same technology, technology becomes less of a competitive

advantage and the focus can shift to the science within the trials. The next

step, and what the industry as a whole is moving toward, is the

establishment of data standards to enable a common infrastructure

covering elements such as CRFs and the questions that form part of the

enrollment and follow-up process.

Science and Progress

Developing standards for trials, tools, and infrastructure will not be easy,

but every industry goes through a version of this process. Over time,

collaborative working has grown over wider geographical areas and

encompassed more people, and the only way to maintain the integrity of

the venture is to use the latest information and communication

technologies. However, these tools should be part of the process, not the

focus of it; they should facilitate the endeavors, not complicate them. In

this way they will enable progress and the development of new capabilities.

In the next few years electronic health records will overtake paper

records in the developed world. In many trials, more than half of the data

will come from sources other than the investigator sites, such as

laboratories, electrocardiograms, scanners, or other digital equipment.

The next big challenge will be working out how to interface with these

technologies. It is possible that what are now data management roles

may morph into ‘data broker’ roles, shepherding the flow of information

securely between systems and across organizations and countries. This

will be necessary in order to eliminate dual processing of information. It

may take another decade, but deploying a web browser fronting

proprietary software to gather data will not be the ultimate solution. It

may have taken a while for EDC to become accepted, but the field is

moving faster now. Pharmaceutical firms no longer have the same

apparently limitless resources and are increasingly not just adopting new

technology and practices but looking at ways to drive them forward.

Overall, the acceptance of technology is gaining pace. People all over the

world are more comfortable with electronic tools. Developing countries

still have an infrastructure issue that may never be—or need to be—

resolved. With wireless communication and better power acquisition and

storage capabilities, emerging countries can leapfrog many of the more

established countries and move full pace into the digital age. Big pharma

may have been lethargic in the past, but have now realized that it

benefits the whole industry to be able to easily, quickly, and securely

share data, and are helping to drive this process forward. Ironically, as

technology has improved, its status as a defining feature has reduced;

instead, it has mutated from being pivotal to being essential. ■


State-of-the-Science New RDC Paradigm

As more companies adopt the

same technology, technology becomes

less of a competitive advantage and

the focus can shift to the science

within the trials.

Users needed to change their

mindset and acknowledge that

Oracle RDC is more than simply

a data management tool.


As the pharmaceutical industry moves into the eClinical age, much is

changing and more change is possible. Technologies such as electronic

data capture (EDC) have enabled clinical studies to become larger and

more complex. Furthermore, they have supported the global expansion

of trials, particularly to patients in developing countries. However, the

introduction of EDC has also put more pressure on companies to

increase the scope of their trials, all while containing costs.

PPD is a large global contract research organization (CRO) working

within the trends of globalization and more complex eClinical trials.

The company’s large global presence means that clients can take

advantage of its economies of scale, while the web-based nature

of its primary platform—Oracle Remote Data Capture (RDC)—allows

easier access to trial data in a real-time fashion for safety and

monitoring purposes. Furthermore, PPD has worked as a beta tester

for Oracle’s latest offering, Oracle RDC 4.5.3, focusing on leveraging

the technology for investigator use and improving its data

management functionality.

Changing Face of Clinical Trials

Clinical trials are becoming larger and more complex but can be carried

out more quickly than ever before, all thanks to the adoption of

eClinical technologies. At the start of 2009, PPD is seeing 50% of its

trials undertaken in an electronic format. Within the next few years, it

is predicted that electronic trials will overtake paper-based trials, but

there will still be a need for paper trials for some specific trial types and

sizes. EDC platforms such as Oracle RDC allow investigators to monitor

trials more easily and to access and analyze vital data on a regular basis.

Such platforms also allow regulatory bodies and data safety

monitoring boards (DSMBs) easy access to trial data. Easier access

means that agencies such as the US Food and Drug Administration

(FDA) will be able to play a more participatory role in the setup and

running of trials to ensure that quality and standards are maintained

in this new wave of eClinical technology.

Business Goals

EDC has been a major enabling technology, allowing companies to

extend their business goals beyond what was possible with paper

systems. The web-based Oracle RDC 4.5.3 gives companies a larger

global reach to monitor and manage data across the world. Processes

such as collating all global data used to take four to six weeks, but can

now be performed in one to two weeks. Database lock time has been

reduced to 10 days (100–400% less time than when using paper).

However, while eClinical technologies have allowed the pharmaceutical

industry to make leaps forward in clinical trial management, they have

also increased the pressure to run faster trials that enroll even more

patients. This puts pressure on trials to become more global, particularly

as it becomes more difficult to find treatment-naïve patients closer to

home. In addition, the cost of drug development is rising, but the

pressure remains on pharmaceutical and biotechnology companies

to contain costs.

In the face of these changing times, CROs can help ease the pressure

for their clients. A client can take advantage of the experience and

economies of scale of a large CRO, such as PPD. Global CROs have

more contacts and investigators in various countries worldwide,

including in the developing world, and they can generate efficiencies

in terms of data management.

Globalization

Clinical trials are increasingly pushing out into new global locations,

and the spread has been particularly rapid in developing countries. This

means that CROs need to be global too (see Figure 1). PPD has been

running studies spanning the globe, with offices in 33 countries

worldwide. As well as multiple offices in North America and Europe,

the company has a large number of bases in Latin America and Asia,

an office in South Africa, and one in Israel. PPD is continuing to expand

its presence, anticipating a rise in trial volume in these regions.

a report by

James Streeter

Executive Director, Electronic Data Capture, PPD, Inc.

Improving and Monitoring Clinical Data Management in the eClinical Age

9© T O U C H B R I E F I N G S 2 0 0 9

Improving and Monitoring Clinical Data Management

James Streeter is Executive Director of Electronic DataCapture (EDC) at PPD, Inc, a position he has held since2006. He applies his extensive experience in EDC, dataacquisition, data management, and analysis, workingdirectly with clients to incorporate EDC into theirdevelopment programs. As the leader of PPD’s globalEDC core team, he provides project teams with thetechnical process and training support services necessaryto ensure proper deployment and execution during the

critical start-up, monitoring, and close-out phases of clinical studies employing EDC. MrStreeter gained much of his EDC experience at Pfizer as Senior Director of Global ClinicalData Services, heading the Global Data Acquisition Department for the company’s globalresearch and development organization. Prior to joining Pfizer, he was a senior hardware,software, and systems engineer for the US Navy Underwater Sound Laboratory, with afocus on data acquisition and analysis.

At the start of 2009, PPD is seeing

50% of its trials undertaken in an

electronic format. Within the next few

years, we predict that electronic trials

will overtake paper-based trials.

PPD_Streeter_revised1.qxp 12/5/09 4:35 pm Page 9

With a totally web-based platform such as Oracle RDC 4.5.3, these

disparate locations can communicate effectively. Employees can log in

from various locations both on- and off-site to manage, monitor, and

analyze data. The platform has a footprint of zero—it needs no

installation at the actual trial site—thus avoiding many potential setup

issues. Full training for the system can be achieved in 45 minutes to an

hour, and if a site already has experience using another EDC program,

the process is even easier.

New Research Areas

As companies push further into these new regions, it is important to

remember that many sites will be new to clinical research. In such

cases, implementing eClinical technology can prove challenging.

Moreover, relationship building and proper training is needed to

promote investigator confidence in using these platforms. Getting

clinical sites up and running can be especially problematic in

developing countries that lack the standard IT infrastructure.

However, technology challenges in these areas are starting to improve.

Technology is spreading rapidly and many of these regions are gaining

high-speed Internet links and other forms of access. Countries are

generally willing to adapt to eClinical demands quickly, with

investigators keen on using new technology platforms that can boost

their clinical trial parameters. Particularly poor areas, such as some

regions in Africa, completely lack basic communications infrastructure

such as telephone lines, and are likely to do so for some time to come,

but they have already made the leap to using cellular phones based

on wireless networks. New eClinical technologies that can run using

wireless communication networks or satellite links are emerging,

effectively bypassing the need for a classic IT infrastructure.

Enhancing the Investigator Experience

The importance of the investigator in implementing eClinical trials has

long been overlooked, but now enhancing the investigator eClinical

experience is becoming a key part of leveraging such technologies.

EDC platforms need to be user-friendly to give an investigator

confidence in using the system and to increase the efficiency and trial

workflow rather than slow it down. Finding clinical investigators is very

competitive and CROs are having to work harder to retain them.

There is also demand for an eClinical tool that allows investigators to

handle larger volumes of complex data more easily. With Oracle RDC

4.5.3, case report forms (CRFs) are easy to navigate and provide search

and sort functions and a robust system of edit checks to ensure data

accuracy. There is a combined interface for discrepancy management

and the CRF itself on one screen, so that users can scroll through and

work on discrepancies without having to add pop-up windows or use

different tools. In addition, investigators can interact with monitors

and data management teams in a more real-time fashion, which

means that they are able to close queries within days—something that

could take one to two months with paper-based systems.


Improving and Monitoring Clinical Data Management

PPD global offices

Number of clinical trials

Canada = 4,768US = 33,369Mexico = 774Carribean = 1,010South America = 1,576Europe = 13,080Africa = 1,362Middle East = 1,952Russia = 947East Asia = 838China = 3,249Australasia = 1,882Japan = 907South-East Asia = 901

0–1,000

1,000–2,000

2,000–10,000

10,000–20,000

20,000–40,000

US (26)

Canada

Mexico

Peru

Chile

BrazilSouthAfrica

Belgium (2)UK (4)France

GermanyItaly

The NetherlandsSpainPortugal

SwedenDenmarkPolandCzech RepublicHungary

TurkeyGreece

Australia

Taiwan

Thailand

Singapore

India (2)

China (2)

Korea

Israel

Figure 1: Globalization of Clinical Trials and of PPD

Source: www.clinicaltrials.gov, July 2008.

Electronic data capture platforms

need to be user-friendly to give

an investigator confidence in using

the system and to increase the

efficiency and trial workflow rather

than slow it down.


Of course, the platform also literally reduces the volume of paper used,

so investigators no longer have to find storage for bulky casebooks. All

clinical data can be stored on a CD.

An Agent of Change

PPD has worked closely with eClinical providers such as Oracle

specifically on Oracle RDC, as well as its business intelligence, safety

packages, and clinical trial management system (CTMS). As part of its

strategic development partner (SDP) program, PPD has acted as a

customer advisor and worked as a beta tester on a pre-release version

of RDC 4.5.3. PPD’s investigator focus made it able to provide feedback

to Oracle on various issues and act as a voice for its various investigator

sites. PPD’s participation has helped increase investigator site

performance, simplify the user interface, eliminate software installation

issues, and realize a fully web-based system.

PPD particularly focused on how various eTechnologies would be used in

practice by investigators and assessed how the various tools could make

the job of the investigator easier. In the first instance, the firm directly

questioned investigators, asking what eClinical abilities they would need

to optimize their resources. The company also visited various investigator

sites as part of its research, getting feedback from investigators and

testing the systems first-hand to establish which add-on elements would

improve the platform and help trial management run more smoothly.

By focusing attention on investigator usage, PPD has become a

technology leader in the eClinical field. Understanding the

investigator’s technology needs improves the investigator’s relationship

with eClinical systems and its relationship with the CRO. As a result,

PPD is better able to retain investigators in wide-ranging global

locations, making it a more attractive proposition for potential clients.

It is not just investigators that have to cope with the switch to

eTechnologies; CROs must adapt too. Employing eClinical platforms

means huge changes for the day-to-day workflow of monitors and

project management staff. PPD has implemented comprehensive

training programs and hired employees experienced in using such

platforms. Once employees have sufficient training and are exposed to

eClinical studies, they start to feel the benefits to their workflow,

finding they can work faster and more efficiently, managing data and

responding to queries in real time.

Technology Integration

Unusually for a CRO, PPD also has its own informatics division—

CSS Informatics—which provides software for pharmaceutical,

biotechnology, medical device, and other CRO companies and offers

consulting services for clinical trial and drug safety applications.

CSS Informatics can host all types of eClinical EDC system for

clients and provide training on their use. As a result, PPD has

experience using a variety of eClinical systems on the market,

performing approximately 125 studies using Oracle Clinical RDC and

80 studies using third-party EDC platforms. The combination of PPD

and CSS Informatics’ service offerings creates a broad, integrated

service for clients.

Along with Oracle’s RDC platforms, PPD also has an in-house EDC

system. While Oracle’s RDC is more geared toward phase I–III trials,

which are more standardized in their trial management processes,

PPD’s proprietary EDC platform—GlobalView—is used for post-

marketing and medical device trials, as it allows for more dynamic

control of these extended and highly variable studies. As GlobalView

has a programming ability, PPD can integrate its system with Oracle

RDC to share data across both systems.

Future Perspectives

With each phase of eClinical development, technologies are

increasingly able to cope with larger, more complex trials, a trend

that is likely to continue into the future. For CROs, one of the biggest

issues will be ensuring adequate training for employees and

investigators using these systems. The future direction of all of these

systems will be determined by how well we can consolidate them and

integrate data.

Currently, there are a variety of eClinical systems, including CTMS and

safety and database management systems, that tend to work

separately. In the future, companies are looking to combine and

integrate these systems using data warehouses and business

intelligence, ending the need to sort data manually. In addition, web-

based platforms will make it far simpler for systems to communicate

with each other.

Eventually, technology will progress to where firms only need to set up

one central system to control all variables within the eClinical

paradigm. A single massive coordinated system would have a single

login for users to view all aspects of the trial in real time at any time.

Clinical trials using such a system would create cost and time savings,

allowing CROs to run their studies more efficiently and to collect

higher-quality data. The end result would be a more integrated

approach to eClinical technologies and faster, larger, and less costly

clinical trials. ■


Improving and Monitoring Clinical Data Management in the eClinical Age

Understanding the investigator’s

technology needs improves

the investigator’s relationship

with eClinical systems and its

relationship with the contract

research organization.

With each phase of eClinical

development, technologies are

increasingly able to cope with

larger, more complex trials.


C3i_ad.qxp 8/4/09 4:50 pm Page 12

The use of electronic data capture (EDC) technology is becoming more

widespread: estimates are that approximately half of all trials now

employ EDC, and 32% of sites use Internet-based EDC,1 with spending

on EDC solutions set to exceed $3 billion by 2011—a 15% growth rate

from 2007.2 This means that sponsor companies have the capability to

run more complex and cost-effective clinical trials across the world.

Systems such as Oracle’s Remote Data Capture (RDC) platform are

designed to help sponsors and contract research organizations (CROs)

retain efficient and effective control over clinical trials in an

increasingly regulated industry. While new technology can be a great

enabling tool, it must be simple and useable for those at the heart of

the trial—the investigators. Burdening investigators with unwieldy,

intractable new technologies will not improve efficiency and can even

be detrimental to the progress of the trial.

In order to optimize the use of this innovative and promising

technology, investigators need access to training and specialized

technical support. Consequently, as the use of EDC platforms has

grown, so too have expert technology service companies such as C3i,

which act as a bridge between the investigator and the sponsor

company to provide that support network. C3i aims to maximize the

benefits derived from these enabling technologies and smooth the

transition from old to new technologies for investigators, whose main

focus needs to be on conducting the trial as efficiently as possible.

Clinical Trials and Tribulations

In an industry where new technology is constantly replacing old and

new challenges are being met, clinical trial design and management is

also progressing. EDC methods represent an important leap forward in

clinical trial technology, allowing for more reliable record keeping,

easier access to data from multiple sites across the globe, and larger

trials that can be completed more quickly and efficiently than ever

before. However, the transition period while implementing any new

technology is unlikely to be entirely smooth. Programs such as Oracle

RDC will undoubtedly improve and modernize clinical trial operations

in the pharmaceutical industry in the long term, but setting

up the new platform or upgrading the old one can present many

challenges in the short term, one of the biggest of which is to make

the entire environment user-friendly for investigators and investigator

site staff.

The Growing Demand On and For Investigators

While pharmaceutical companies and CROs will be highly familiar with

the technology they are working with, the same is not true of

investigators. It is important to remember that investigators will have

other daily duties alongside running trials, many of which will require

their own tools. Any time spent struggling with a program or

technology for a specific trial will be a substantial burden on their

resources, and is unlikely to give them a positive view of the trial

sponsor. For them, EDC should be an enabling tool that helps

streamline workflow. However, this has not always been the case; in

the past, such programs have rarely been designed with investigators

in mind.

In addition, recruiting investigators for a study is a critical process, and

one that is getting harder as the number of trials rises (see Figure 1).

Sponsors and CROs effectively have to compete for the best

investigators, who should therefore be treated as customers rather

than employees or associates. Thus, the sponsors and CROs must be

easy to work with, and that is reflected in the technology they use. It

Optimizing and Supporting Remote Data Capture

a report by

Dave Hanaman 1 and Rob Vol lkommer 2

1. Executive Vice President and Co-Founder; 2. Vice President, Clinical Services, C3i, Inc.


13© T O U C H B R I E F I N G S 2 0 0 9

Dave Hanaman is Co-Founder and Chief Sales andMarketing Officer for C3i. He is responsible for sales,marketing, product development, and alliances.Additionally, he consults directly with many of C3i’s blue-chip clients. He is experienced in a wide variety ofsubjects related to clinical support operations andcustomer relationship management, focusing on thetechnology environment, performance improvement, andreturn on investment. A frequent lecturer and prolific

writer, Mr Hanaman has developed and taught courses for universities, spoken at industryconferences, and written numerous articles, and is frequently quoted in the industry press.A graduate of the University of California at Berkeley, he also served as an IntelligenceOfficer in the US Navy.


Rob Vollkommer joined C3i in November 2002, and iscurrently Vice President of Clinical Support Services.He is responsible for the development and delivery ofsupport services to meet the specific requirements of thecompanies conducting clinical trials (e.g. multilingual helpdesk, user accounts creation/administration, technical siteassessments, and Internet-based training). He holds a BScin electrical engineering from Columbia University and anMBA in management and operations management fromNYU Stern School of Business.


Electronic data capture should

be an enabling tool that helps

streamline workflow.

C3i_Volkommer_revised2.qxp 18/5/09 12:30 pm Page 13

is vital for the sponsor to have user-friendly technology and an

effective support network to train and assist investigators.

Until recently, the problem of investigators struggling with new EDC

technologies had been underestimated and under-appreciated. The task

of supporting them tended to fall on site monitors—the clinical research

associates (CRAs). However, this meant that CRAs could themselves

become overburdened with technical support issues, leaving them with

less time to carry out their core role. This is where C3i steps in: its support

network works to alleviate pressure and minimize time-consuming

interruptions for the CRA, help the investigator to use the technology

effectively, and prevent the new technologies from becoming a burden.

In addition to usability, the total cost of ownership is an important

factor. Any new technology requires substantial start-up capital. It

is important to leverage such technologies to maximize their potential

for the sponsor and the CRO and reduce costs in the long run.

Effective setup, training, and support shortens the time to a return

on investment.

Integrating Technology

Along with new technologies, trials themselves are becoming more

complex. In fact, this is a self-sustaining cycle: innovative technologies

have enabled trials to become larger, covering multiple sites in many

countries across the globe, which, in turn, increases the volume of

information flow from site to site. Furthermore, while EDC is growing

in acceptance, it is far from universal. There are currently many

different data modalities within a trial that must be dealt with,

including lab data, which is often faxed through, adverse event

reporting and safety issues, which are not yet fully electronic, and

decisions taken about protocol adjustments on the trial.

In fact, the running of clinical trials is likely to become even more

complex for many investigators even as they begin to realize the

benefits of EDC technology. It will take a while until EDC has

penetrated all aspects of a trial. Indeed, EDC is not the only electronic

system that runs during a trial. For example, although the sponsor and

the CRO will use the same data collection platform, the CRO may use

its own system for clinical trial management or other parts of the study

such as enabling payments. In such a case, integration of the sponsor

company and CRO systems may remain a challenge for the foreseeable

future—a barrier that could hinder progress for some time.

Companies such as Oracle are working hard to streamline technology

to allow integration of all aspects of clinical trials. The ultimate goal

is to simplify the total solution so that there is one central point for

access to all the different aspects of the trial—a kind of ‘dashboard

portal’ where investigators, CROs, and sponsors can reach all of these

disparate systems through a single login. However, the industry is not

there yet. There is still a strong need for technical support to help the

investigator navigate and deal with this complexity and lack of

integration, and this is where a company such as C3i can intervene and

help investigators navigate such systems, with the goal of making the

overall research process more efficient.

Implementing and Supporting Large-scale Global Trials

There are many consequences of running large-scale global trials. For a

start, there is added pressure to recruit the best subjects. It is becoming

increasingly difficult to find treatment-naïve patients in Western

countries; therefore, attention is being focused on the East, toward

countries such as Russia and China. This, in turn, introduces complexity

to the support process, which must now handle different languages

across multiple time zones.

Connectivity is another issue: modern multicenter trials heavily rely on

adequate Internet access so that sites can communicate effectively

with each other and with the sponsor. Investigators in developing

nations may not have regular access to a reliable Internet connection,

or in some cases even a computer. Using such investigators may mean

having to ship out equipment and laptops just so they can access EDC

applications, including Oracle RDC, which will significantly affect the

budget for the study. As a rule of thumb, if a sponsor is considering

using investigators in Russia, China, or maybe Latin America, it will

need to plan to provide 10–14% of sites with computers; that figure

would be just 1–2% in the US (see Figure 2). In addition, companies



Number of investigators

2000 2004 2007 2009

Num

ber o

f inv

estig

ator

s/tr

ials

Number of trials80,000

70,000

60,000

50,000

40,000

30,000

20,000

10,000

0

*Estimated. Sources: Thomson CenterWatch, Clinicaltrialstoday.com, Clinicaltrials.gov, Laine et al.3

Figure 1: Competing for Investigators

Modern multicenter trials heavily rely

on adequate Internet access.

Until recently, the problem of

investigators struggling with new

electronic data capture technologies

had been underestimated and

under-appreciated.


need to assess the Internet activity and bandwidth at these sites to

ensure they can cope with the demands of the EDC technology. These

are all important considerations in terms of potential returns on

investment from the trial.

Critical Need for Training

Trying to understand any new EDC technology platform can seem

daunting at first, and training and support are essential to smooth its

acceptance. The next-generation Oracle RDC technology offers

increased functionality and investigators will require guidance to

optimize their use of the platform. Investigators are the lynchpins of

a clinical trial, but without proper support they can easily become a

trial’s weakest link.

C3i’s role is to help smooth the course of the clinical trial, increasing

the confidence of the investigator and taking the pressure off the

CRA. The company also helps to get the site up and running, sending

out new equipment and laptops if required. As part of this, C3i

performs speed tests for Internet connectivity—something that can

mean the difference between using or not using a site. C3i has

compiled some interesting statistics related to this. During study start-

up, it is not uncommon to have anywhere from five to nine inquiries

from each site over the course of a month, depending on sponsor-

specific start-up procedures (see Figure 3). Traditionally, these inquiries

are handled by the CRAs, but as CRAs manage multiple sites and have

to travel between them, a backlog can quickly develop, increasing

their workload and response times. C3i removes this burden from the

CRA and enables investigators to experience quicker resolutions and

more customer-friendly experiences.

The company operates a 24-hour multilingual helpdesk that

understands the needs of the clinical business and is equipped to deal

effectively with inquiries from sites across the globe whatever the issue,

from losing a password to a program-specific technical problem

(see Figure 4). C3i’s helpdesk services are ISO9001-2000-certified and are

grounded in mature audit-tested processes and procedures for

everything including hiring, training, knowledge management, and

quality assurance. The bottom line is that better training and a more

efficient setup will mean fewer problems downstream, including fewer

helpdesk calls, since less support is needed. These are all potential savings

on long-term costs.

Training the Investigator

C3i begins investigator training with a basic awareness-raising

presentation that introduces the basics of using Oracle RDC. This acts

as a primer for the next stage, which is a self-paced, Internet-based

eLearning system. The 90-minute program can be accessed by users at

their leisure at any time before patient recruitment starts.

Furthermore, investigators do not need to complete the 90 minutes in

one session; the program can be spread over a more manageable

time-frame if required. Once completed, users are given a short

certification exam to ensure that they have understood the training.

The assessment is not intended to be a complicated exercise, but

rather a tool to show due diligence.

The training information is stored online, which is also useful for

regulators and any auditor who wants to check that all investigators

are qualified to use the equipment. Once complete, investigators



Figure 3: Number of Interactions Handled by Support DeskDuring Study Start-up

10

9

8

7

6

5

4

3

2

1

0Client 1 Client 2 Client 3

9.2

5.4

Interactions per site handled by support desk during study start-up

9.1

Sample size >1,400 sites.

Better training and a more

efficient setup will mean

fewer problems downstream,

including fewer helpdesk calls.

During study start-up, it is not

uncommon to have anywhere from five

to nine inquiries from each site over

the course of a month.

Num

ber o

f site

s as

sess

ed

Region

Number of sites assessed Percentage of sites provisioned

15%

11%

7%6%

Sites provisioned (%)

3,500

3,000

2,500

2,000

1,500

1,000

500

0

16

14

12

10

8

6

4

2

0Asia-Pacific Latin

AmericaEurope Africa South

AmericaNorth

America

8%

2%

Sample size >8,000 sites. Source: C3i.

Figure 2: Laptop Provisioning Rates by Region


receive their user ID and credentials and are able to access and use the

system as part of their project.

Case Study—Global Contract Research Organization

One successful case where C3i used its technical support expertise for

Oracle RDC involves a global CRO. The firm was setting up a large

project involving 1,000 sites in 40 different countries that needed to

be up and running in just 90 days—a major challenge. With C3i’s help,

the project was initiated within the time constraints by helping to

streamline the setup and workflow.

The first steps were to establish the RDC training program, starting

with building the eLearning environment for the investigators.

Following this, C3i began technical site assessments, checking that all

sites had appropriate computers and Internet connectivity.

Accordingly, the company shipped laptops to any global sites without

suitable hardware. The next step was to create user IDs for all

individuals who needed to interface with the RDC program.

On average, there is one investigator, one study nurse, and one study

coordinator per site, making a total of around 3,000 user IDs for this

project alone. As part of its work, C3i was also able to take on tasks

normally performed by the CRAs, leaving them better able to focus on

aspects more central to their job, such as recruitment and clinical audits.

For this project, C3i was working with Oracle RDC 4.5.3—the most

recent upgrade—and the improvements in this version could be clearly

seen with the more efficient implementation. The site assessment

process, for example, was far smoother with the new version, which

directly accelerated the process of getting the study up and running.

There was also a 5–15% reduction in basic usability questions from

investigators at the helpdesk, which is particularly impressive when

installing a new platform.

Overall, this global CRO was able to impress the sponsor company by

getting the trial up and running in a relatively short time-frame. The

eLearning environment proved very successful, and the number of

helpdesk calls was far below the number forecast. The end result was

a satisfied investigator, a CRA who was not too stretched in their

duties, and a CRO that met its timelines for a very important sponsor.

Benefits in the Future

New EDC platforms such as Oracle RDC can dramatically increase the

functionality of clinical trials, allowing for more complex and

demanding trials that are run more efficiently. However, it must not be

forgotten that at the heart of the clinical trial is the investigator—and

it is critical that his or her needs are met. Effective investigator training

is therefore a must in order to reap the benefits of this promising

technology. Continued support for the investigator throughout the trial

via companies such as C3i will also mean more efficient use of the

technology, more satisfied, engaged investigators, and improved

returns from investment in these enabling technologies.

Appropriate training and support will also lead to a better investigator

experience, which will be inextricably linked with the CRO and the

sponsor company, giving them a strong competitive edge. In the long

term this could boost investigator retention rates—an important result

in a field where investigators are a valuable commodity. ■



1. CenterWatch, EDC Adoption in Clinical Trials, A 2008 Analysis,2008. Available at: www.bio-itworld.com/EDC-ADOPTION.aspx

2. Health Industry Insights, US Electronic Data capture2006–2011, Spending Forecast and Analysis, 2007.

3. Laine C, et al., Clinical trial registration—looking back andmoving ahead, N Engl J Med, 2007;356(26):2734–6.

Figure 4: Typical Problems Handled by Helpdesk

26%

24%

22%

10%

EDC study

Oracle RDC support

7%

1%

24%

36%

11%

9%

9%

7% 5%5%

3%1%

0%

Oracle RDC

Password reset

User account management

Clients’ web portal

Citrix (Gateway for previousversions of Oracle RDC)

Provisioning

User account issue

Other Oracle RDC issue

Error message

Time-out/disconnection issue

Data entry issue

Training issue

Inserting page/visit

Verification/approval

Discrepancy/query

Blanking or unblanking pages

Major event (0%)

In the long term this could boost

investigator retention rates—

an important result in a field where

investigators are a valuable commodity.

The firm was setting up a large

project involving 1,000 sites in 40

different countries that needed to

be up and running in just 90 days—

a major challenge.


Clinical Trial Management(Siebel Clinical)

Electronic Data Capture(Oracle Remote Data Capture)

Clinical DataManagement System

(Oracle Clinical)

Safety Reportingand Call Center

(Oracle Adverse EventReporting System)

Term Classification/Dictionary Management(Oracle Thesaurus Management System)

Clinical Integration, Warehousing, and Reporting(Oracle Life Sciences Data Hub)

eClinical Visions

Oracle Health Sciences—Clinical Development and Safety Applications

Oracle Corporation500 Oracle Parkway, Redwood Shores, CA 94065

HEALTH SCIENCES

Contact

[email protected]/industries/health_sciences

Accelerating Insights for Better Health

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MOC.S

GNIFEIR B

HCU

O T.W

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Cardinal Tower12 Farringdon Road LondonEC1M 3NN

EDITORIAL Tel: +44 (0) 20 7452 518177Fax: +44 (0) 20 7452 50577 0

SALES Tel: +44 (0) 20 7526 2347Fax: +44 (0) 20 7452 5606

E-mail: [email protected] www.touchbriefings.com

B R I E F I N G S

Oracle Corporation500 Oracle ParkwayRedwood ShoresCA 94065

General inquiries: +1.800.ORACLE1

International: +1.650.506.7000

www.oracle.com/industries/health_sciencesEmail: [email protected]

WW

W.O

RACL

E.CO

M

HEALTH SCIENCES

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Remote Data Capture: Acquisition and Analysis (PDF) - Oracle

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