eClinical Feedback: Why Sponsors Need an Integrated, Closed-Loop Clinical Process

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David Gemzik, Vice President, Implementation Services
Sean Cheng, Senior Product Marketing Manager

Faced with slowing pipe lines and spiraling costs in new drug development, sponsors in recent years have been trying to conquer the last frontier in process improvement: R&D. However, increasing complexity, regulatory pressure and public scrutiny have placed further stress on the industry’s existing clinical trial process. As a result, today’s, clinical trial processes fail to address today’s challenges and, in many ways, stifle future innovations and the implementation of new approaches.

Like any industry at the advent of transformation, technology is the key to providing increased efficiency and productivity. In recent years, the clinical research industry has witnessed the wide acceptance and adoption of electronic data capture (EDC), which now forms the critical foundation for a widespread eClinical strategy. However, EDC is only one piece of the puzzle. In order to enable an intelligent eClinical process, sponsors require a closed-loop clinical trial system with complete end-to-end integration throughout the life cycle of the trial. With this suite of eClinical tools, sponsors will be able to optimize the entire clinical process across the enterprise and gain significant competitive advantages in R&D. Benefits of an Integrated End-to-End System A true closed-loop clinical trial system allows dynamic information to flow bi-directionally in real time throughout the entire clinical trial process, from design and budgeting to execution and closure. The system must communicate with other enterprise solutions, including operational, manufacturing, finance and accounting systems. As each system intelligently draws insights from one another, the overall performance of the trial is optimized. Experience from industries that have transformed processes through technology can be applied to the clinical trial space as well. Manufacturing and banking industries often implement enterprise resource planning (ERP) systems, proving that an integrated best-of-breed approach across systems based on industry standards yields greater returns and transcends industries. In a well-integrated eClinical system, sponsors can begin to utilize industry benchmarks and historical performance data to further optimize the performance of the trial. For example, protocol feasibility can be validated by querying existing data to understand patients’ availability based on defined inclusion/exclusion criteria. Such data mining capability allows the system to “learn” from each trial and continuously improve its “intelligence.” It also enables sponsors to apply best practices across the organization by tapping into a centrally-managed knowledge repository. The EDC system can consider stricter validation rules for data queries associated with primary study objectives defined in the protocol. As a result, the overall performance of the entire clinical trial can be enhanced through intelligent “dialogues” among various trial processes and systems. The impact of a closed-loop clinical trial system goes beyond a smarter planning stage. Downstream processes also benefit tremendously from full integration with the front end processes by gaining intelligence from enriched metadata that provides end-to-end clinical data context and reveals critical operational insights. Standardized metadata models in the system allow accurately captured design information to be easily retrieved by all downstream processes. Propagating design information throughout the entire system not only enables reuse of the vast amount of work already performed throughout the clinical process, but it also reduces the risk of losing the focus of the trial as protocol information is manually interpreted and reinterpreted at multiple phases. Such dynamic linkages with the trial design process add efficiency and intelligence to the execution and analysis phases. Conclusion The pharmaceutical industry has just begun to move beyond simple EDC adoption and disparate point-solution systems and is beginning to embrace more standards-based, integrated technology solutions in order to elevate the efficiency and effectiveness of existing clinical trial processes. To solve many of the challenges that lie ahead, sponsors must realize that performing digital upgrades to individual clinical trial processes alone is not sufficient. Only a closed-loop clinical trial system where all components are well integrated can enable sponsors to impact the entire trial process, maximize time and realize cost saving benefits. n Medidata Solutions Medidata Solutions is a global provider of hosted clinical development solutions that enhance the efficiency of customers’ clinical development processes and optimize their research and development investments.For more information, visit

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