LIFE SCIENCES
Major pharma company evaluates impact of
protocol amendments on cycle times to improve
clinical trial effectiveness
Client
A leading U.S.-based multinational
pharmaceutical corporation
A research-based organization, the client regards clinical trials as a core
competence. Attaining the highest possible effectiveness in trials is crucial
to the company’s market position and financial performance. However,
the company is subject to the industry-wide problem of amended
Industry
protocols, including rising number of procedures, length of study, and
Pharmaceuticals
contribute to high and variable cycle times. Genpact addressed these
Business need addressed
Improve performance of clinical trials
Genpact solution
Genpact conducted a study to discern
the link between amendments and cycle
time, comparing different phases and
therapeutic areas
number of investigative sites. Amendments are costly to implement and
concerns with an analysis of trial factors such as protocol deviations, data
integration, and regulatory issues—providing a clear, actionable path
to resolution.
Cycle times raised warning flags about
the impact of amended protocols on trial
performance
• Increasing volumes of protocol amendments bore a rising cost of
implementation
Business impact
• Cycle times in trials were high and increasingly variable
• Regulatory compliance
• Data integration from multiple sources proved challenging
• Adaptation and flexibility
• Protocol deviations and regulatory issues added to compliance pressures
• Growth and scalability
Genpact analysis quantified the cause-effect
link and clarified differences among therapeutic
areas and trial phases
• Increasing protocol amendments had a direct impact on lengthening
cycle times
• The treatment areas most affected were neurology and cardiovascular
• Phase IV post-marketing surveillance studies were the most impacted of
the trial phases
Business impact delivered
The in-depth study clarified the link between the incidence and type of amendments to cycle times across different therapeutic areas
and trial phases. This led to several improvements in handling clinical trials:
• Decision support for applying amendments based on volume and cost considerations
• Selection of amendment type according to impact on specific therapeutic areas
• Performance benchmarking of clinical trials, taking into account the effect of amendments
• Measurement of deviation from planned completion dates and cycle time
• Quantified cost impact of amendments
With the study results in hand, Genpact worked with the client to improve the effect of cycle times on clinical trials. Deeper insight
into the phases and therapeutic areas led to targeted initiatives to improve trial performance and regulatory compliance.
About Genpact
For more information, contact:
Genpact Limited (NYSE: G), a global leader in business process management and technology
services, leverages the power of smarter processes, smarter analytics and smarter technology to
help its clients drive intelligence across the enterprise. Genpact’s Smart Enterprise Processes (SEPSM)
framework, its unique science of process combined with deep domain expertise in multiple industry
verticals, leads to superior business outcomes. Genpact’s Smart Decision Services deliver valuable
business insights to its clients through targeted analytics, reengineering expertise, and advanced
risk management. Making technology more intelligent by embedding it with process and data
insights, Genpact also offers a wide variety of technology solutions for better business outcomes.
swati.shrivastava@genpact.com
For more information, visit www.genpact.com. Follow Genpact on Twitter, Facebook and LinkedIn.
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