Project Management in Clinical ResearchSanjay Akhani, Sr. Clinical Project Manager, Quintiles

DISCLAIMER

• Although I am employed by Quintiles Research India Pvt. Limited, the material contained in this presentation has not been sponsored or endorsed by Quintiles Research India Pvt. Limited. No association of this material with Quintiles Research India Pvt. Limited, its policies or practices is expressed or implied.

• The concepts and information herein are freely available from many sources, and their sharing and dissemination is highly encouraged. However, please do not use the slides themselves without my permission as their format and configuration are particularly identified with me. Thanks!

Sanjay Akhani

Clinical Research: Project Management

• What is project management in Clinical Research

• PM tools and techniques applied in Clinical Research

• Project Management Plan for Clinical Research

• CRO and SMO Management

• Optimize patient recruitment

• Working with remote and multicultural teams

TimeCost

ScopeRisk

Quality

Recourses

Project Management Constraints

Timeline

+ US

+++ Asia, Africa

Cost

+++ US

+ Asia, Africa

Risk

+ US

+++ Asia, Africa

Disclaimer: This is just an example, not based on fact.

Project Management in

Clinical Research

Business case

Define Objectives

Stake Holders

Develop Project Charter

Initiation

Scope Management

Budget/Milestones

Project Management

Plans Kick-Off Meeting

Planning

Regulatory And Site

Systems/ VendorsCommunication

Execution

Training

Project Performance

Review

Change Management

Stake HoldersRisk Audit

Monitoring and

Control

DB lock and CSR

Sites Close out

System and Finance

Archival & Lessons Learnt

Closeout

Responsibilities of

Project Manager

Responsibilities of Project Manager

• Coordination, Communication, Escalation oAcross Functional AreasoAcross Stakeholders

• Team Motivation and Management

• Status Review/Risk Management

• Financial Management

Clinical Operations

DMPhV

Regulatory Bodies &

Sites

Project Manager

Vendors

PM Tools and Techniques applied in Clinical Research

Project Management Tools/Techniques

Project Management Software - MS-ProjectCritical Path AnalysisEvent Driven AnalysisPatient/Treatment PathwaysWBSRolling Wave Planning Bottom up EstimateAlternative Analysis Contract and Contract Change Control System Variance/Trend Analysis Analogous Estimate HistogramProcess analysis/Quality Audits Issue/Action item logRisk logRACI ChartAssumption Analysis Survey/InterviewsProject Information System

Project Systems

Communication

• E-mail/mobile/telephone/fax/podcast• Sharepoint/WebEx

Data Reporting/Analysis/Archival

• e-CRF/IVRS/IXRS/Web portal• Clinical Trial Management System (CTMS)• e-Dairy/Patient cards• Electronic File Management System

Project Management Plan in Clinical Research

Project Management Plan

• Scope/Budget/Milestones

• Regulatory strategy

• Patient recruitment

• Risk management

• Quality management

• Vendor management

Clinical Operation

Vendors

DM, PhV,

Medical

RegulatoryPM

Spon

sor

Study Milestones• Project Charter Approval • Kick-off Meeting• Final Protocol Ready• First Site Selection• Investigator’s Meeting• First Site Activation• First Patient In (FPI)• Last Patient In (LPI)• Last Patient Out (LPO)• Database Lock• Draft Table and Figure Listing • Draft Clinical Study Report• Final Clinical Study Report• Last Site Close out• Archival of Study Document • Project closure

Country/Site Strategy

Country Strategy• Regulatory Agency

• Sequential submission (Long start up time)• Parallel submission (Short start up time)

• Central Ethics Committee/Local/Institutional Ethics Committee• Contract with Investigators/Institutes

Site Strategy • Patient pool• Relationship/past performance

CRO and SMO Management

Contract Research Organization (CRO) Management SelectionTherapeutic experience and geographic presence Relationship with stake holdersIT infrastructure

Management/KPIEducation/Experience/Training/Attrition of Key CRO staffWeekly/Monthly status review (Start up, Recruitment, Maintenance and Closeout)

Start up

• Feasibility• Site selection• EC/Contract• Regulatory

Documents • Site Initiation

Recruitment

• Site activation• Patient

Recruitment• Site monitoring

Maintenance

• Patient retention• Data entry/query

resolution• IP accountability

Closeout

• Site closeout• IP return• Archival of study

documents

Site Management Organization (SMO) Management

• Relationship with Investigators/Hospitals/Institutes• Experience/Training of staff

KPI

• Patient recruitment/retention/compliance • Data entry/Query resolution• IP accountability

Optimize Patient Recruitment

Patient Recruitment • Recruitment Expectations/Planning/Contingency

• Challenges and Risk Potential and Actual Barriers from the Country’s/Site’s/Patient’s

Perspective

• Recruitment Plan Country/site identifications/selection Recruitment projection/adjustments Pre-initiations activities Recruitment tools and methods

Patient Recruitment: Methods and Tools

• Site staff training/contacts • Referral Network/Database search• Advertisement and other recruitment aids• Investigator /SC Teleconferences• Web based study-specific patient recruitment

tools

• Patient flyer/brochure• Informed consent flipchart• Newspaper /Social media ad

Patient Facing Tools

• Study reference cards• Mini protocols/Resources CD• Physician slide deck

Site Facing Tools

• Welcome binder/Thank you card• Visit reminder card• Patient drug instruction card

Patient Compliance

An educated patient is more retainable and compliant

Recruitment Toolkit

Recruitment Contingency

Booster visits

Activate back-up sites/countries

Implement Escalation Plan for slow/non-enrolling Sites

Working with Remote and

Multicultural Teams

Working with Remote and Multicultural Teams

Challenges

• Time zone difference

• Communication style

• Cultural differences (High to Low context)Cultural differences • Thinks, Acts and Reacts differently• Different approach to tasks • Varying approach on Relationship Building• Personal space, Social etiquette and Belief• Different attitude for conflict, disclosure and negotiation

Cultural DifferencesLow Context High Context

Work Ethics Task-oriented Relationship-orientedWork Style Individualistic Team-orientedRelationship Many, looser, short-

termFewer, tighter, long-

term

Decision Making Logical, linear, rule oriented

Intuitive, Relational

Communication Verbal over non-verbal Non-verbal over verbalKnowledge Explicit, written, formal Implicit, oral, informalSense of Time Present/Future

orientedDeep respect for past

View of Change Change over tradition Tradition over Change

High Context ……….……..…Low Context

Solution

• Global culture/processes/technology• Harmonize learning and development• RACI matrix • Links, Sharepoint site, Communicator• Trust building exercise (time zone, geography and culture)

• Flexi work hour

Working with Remote and Multicultural Teams