This document discusses clinical trial optimization and the challenges facing the pharmaceutical industry. It notes that the average time to bring a new drug to market is 6-7 years, with 7-9% of R&D budgets spent on clinical trials. Key industry trends include increased focus on safety and efficacy by regulators, scrutiny of cost effectiveness by payers, and industry priorities around cost efficiency and speed. The document outlines challenges such as lack of evidence-based decision making, costly delays, unrealistic trial criteria, and inefficient processes. It presents IMS Health's portfolio of clinical trial optimization solutions to help customers with trial planning, execution, and initiation through the use of technology, data, and analytics. Case studies show benefits such as increased recruitment rates

1. Clinical Trial Optimization - A Global View
Nikos Kostaras
General Manager, IMS Hellas
Athens, 10/11/2014

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Clinical R&D Process
Average of 6- 7 Years in Clinical Trials to Bring a New Drug to Market.
7-9% of R&D budget is invested in Clinical Trials.
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11/12/2014

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Critical Industry Trends
Growth Drivers
FDA Safety and Efficacy Focus
Payer Reimbursement and ROI Scrutiny
Industry Cost Efficiency and Speed Priorities
Patent expiries have slowed but not stopped growth, esp. in outsourced solutions.
$20bn+ are invested in Clinical trials every year.
11/12/2014
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(c) 2014 IMS Health Incorporated. All Rights Reserved.

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Industry Challenges in Clinical Trials
Lack of
evidence -
based
decision making
Costly mid-trial rescues
Unrealistic protocol criteria
Disparate, homegrown solutions
Enrollment plans based on guesswork
Can’t find relevant patients
Low performing investigators
No real-time access to global information
No historical evidence
Manual processes
WHY?
•Wasted $$$$$$$
•Lost revenue potential
•Fewer drugs in market
•89% drugs fail in the clinic
•80% trials run behind schedule
•30% investigators don’t enroll patients
•7% annual grant payment increases
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(c) 2014 IMS Health Incorporated. All Rights Reserved.
11/12/2014

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IMS Health Clinical Trial Optimization Portfolio
●Tracking and monitoring
●Rescue scenario modeling
●Patient identification
●Supply optimization
●StudyOptimizer
●Pharmacy outreach
●Protocol design
●Country allocation
●Enrollment planning
●Budgeting
●Real World Evidence
●StudyOptimizer
●Enrollment Benchmarks
●GrantPlan and SOC
●Site planning and selection
●Site budgeting
●Supply planning
●Real World Evidence
●SiteOptimizer
●GrantPlan and SOC
IMS Health Clinical Trial Optimization Solutions
Technology, Data, Analytics
Customer Needs
Current IMS Health Solutions
Trial Execution
Trial Planning
Trial Initiation
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11/12/2014

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Customer Impact
RESULTS:
•100% increase in studies recruiting to plan
•1/3 decrease in non-performing sites
•Estimated savings of $38M
RESULTS:
•30-40 day decrease in patient recruitment
•20% reduction in rescue studies
•30% decrease in variance to plan
•Used to manage partner accountability
Enterprise implementation of StudyOptimizer and SiteOptimizer
Best Practice implementation of StudyOptimizer, extended to manage CROs
Enterprise implementation of GrantPlan and Standard of Care
RESULTS:
•20% savings across Studies in the U.S. by passing those costs to 3rd party insurers
•Used as a template for countries that recognize Standard of Care
11/12/2014
UK pharma giant
US pharma giant
Top US biologic pharma
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(c) 2014 IMS Health Incorporated. All Rights Reserved.

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