“Transforming an Enterprise with Business Process Solutions”

Presented by:

Jim ZweifelExecutive Director of Operations at Biomedical Systems

Shawn MillerBusiness Process Expert

Sponsored by:

Breakout Session Agenda

Biomedical Systems OverviewManaging ECG Clinical StudiesOperational ChallengesWhy “eStore” is a WIN!!“eStore” Desired GoalsCompany Technology InitiativesThe SolutionDriving the InitiativeBusiness Results--PaybackFuture GoalsQ&A

• Founded in 1975• Offices in St. Louis and Brussels,

Belgium• Logistics Offices—Japan and India• Main Business Focus — Manage

Clinical Studies for Pharmaceutical Companies

• 400 studies; 100+ Pharma Companies; 4,000 clinical sites worldwide

Managing ECG Clinical Studies

Why are ECG’s needed in clinical studies?What are the basics for managing an ECG study?

•Send ECG equipment to study sites

•Train the site personnel on taking ECGs

•Collect the ECGs over phone lines; over the web

•Quality check the ECG —”Queries” to the sites

•Possible “Alerts” back to sites

•Cardiologist reads/interprets ECG

•All study ECG data captured and submitted to Pharma Company

Operational Challenges

Uniqueness of Each Study – Labor intensive and manual and paper processes

Processes Required to Manage: • Study “Basics”• Uniqueness of each study protocol

• TAT (turn around time) requirements• Metrics reporting• Measurement methodologies• Different countries—time zones; holiday management • ECG blinding• Visit intervals• ECG comparisons with baseline/other

Operational Challenges

Operational Challenges

Operational Challenges

Different Equipment and Software for Capturing the ECGsFive different systems (equipment and related software)

• Unique processes for each• Unique software for each• Unique ECG algorithms

Large volume of ECGs being processed10,000 per month—in Brussels and St. Louis

Why eStore is a WIN!

Business Need – Ability to provide a single collection and processing system to service customers in the same manner regardless of the source system.

Multiple processes and systems created inefficiencies and waste.

Why eStore is a WIN!

Clinical Need – A unified global approach to meet the level of clinical service and quality demanded by clients, and the industry, based on current business processes and existing systems.

Lack of a system limited study growth and productivity.

Why eStore is a WIN!

Technical Need – Eliminate wasted IT efforts maintaining the accuracy and consistency of study data across redundant legacy systems and operating procedures.

Severely restricted strategic IT direction, collaboration, and internal growth across the organization.

Corporate Technology Initiatives

Adoption of Current Platforms and TechnologyPlatform ConsolidationCentralized Deployment ModelStaff Re-training & AugmentationControlled Development StrategyBuy vs. Build

Technology Platform

External

Internal Applicatio

ns

Intranet (bionet)

• Data tools• Study tools

• Operations• Metrics

• Employee Home

• Access to all

Reporting

Transactional

The Solution

“Our eStore solution, while transformational on its own, is merely a first step in standardizing on Microsoft software to help fuel and support business growth.”

- Mike Brown, Executive Director Software Development

The Solution

Business Process Management Software is a critical component of both the overall solution and IT platform.

BPM software provides rapid, repeatable, development, deployment, monitoring, optimization, and integration of business process solutions across business units and functions.

Driving the Initiative

Developing a Business CaseEngaging the TeamAddressing BarriersDetermining Risks and Mitigation PlanningDeveloping System RequirementsEstablishing Key Performance IndicatorsPerforming Technology EvaluationSelecting Technology StackRe-engineering Processes (Continual)Building Business Process Solution

Key Business Results

Key Performance Indicator – Timeliness of Information Provided Sponsors

ECGs processed within study turn-around time

ECGs processed by cardiologists within 30 minute STAT read window (internal goal)

Complicated, in-depth study metrics automatically generated for Sponsor review

Key Business Results

Key Performance Indicator – Substantial Reduction in Costs

Reduced Labor Costs (related Increased Productivity)

Today - Each ECG requires 3 hours (on avg.)

With eStore – Each ECG will take less than 10 minutes (on avg.)

Reduced Software Development and Overhead Costs

Reduced Paper, Handling and Storage Costs

On average each ECG requires 3 pieces of paper

Key Performance Indicator – Competitive Advantage

Positive feedback from sponsors

Biomedical Systems can provide documented, guaranteed response times to medical drug companies

Measurable study accuracy and effectiveness for clients

Key Business Results

Transforming the Enterprise

Future GoalsAdditional modalitiesImproved measurement and additional measurement featuresEnhanced project management toolsAdditional data cleaning rules managementAdditional acquisition device supportPaperless study archivingExternalizing the BPM solutionContinue to meet expanding services

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