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International Clinical Trials

Informed Integration

The biopharmaceutical industry has benefited substantially in recent years from a wide range of eClinical solutions, including electronic data capture (EDC), interactive voice and web response systems (IVRS/IWRS), clinical trial management systems (CTMS), clinical data management systems (CDMS), medical imaging, lab software and electronic patient reported outcomes (ePRO) solutions. While these technologies have significantly improved efficiency and data quality within specific parts of the clinical development process, there remains throughout the industry a critical need to improve the ability to share information and reduce redundant data entry across the clinical enterprise. This lack of data integration and interoperability is preventing biopharmaceutical companies from reaping even greater rewards from their technology systems, such as improved support for ‘go/no-go’ decisions, greater trial productivity and faster product development.

It is apparent that the adoption of eClinical technologies needs to keep pace with the rapid evolution in the global marketplace of biopharmaceutical products. The industry faces an array of challenges, including mounting pressure to improve product development processes, and bring innovative compounds to market more quickly, significantly higher development costs, and growing regulatory demands, especially the need to increase drug safety.

To improve the productivity and efficiency of clinical trials, biopharmaceutical companies must accelerate their implementation of the next generation of eClinical systems and leverage available technologies to better integrate their trial data. While these technology improvements can present their own challenges, the demands of today’s complex healthcare environment make data integration improvements absolutely vital. With greater strategic access to integrated trial information, biopharmaceutical companies will be able to make better development decisions, eliminate inefficient redundancies, reduce trial delays, improve patient safety and speed up time to market.


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David Stein is Perceptive Informatics’ Senior Director of Product Management and plays a pivotal role in managing the company’s products and services, as well as developing new technology solutions to improve the clinical trials process. Prior to joining Perceptive Informatics in 2002, David worked in Strategic Business Development and Marketing at PhaseForward. He also founded, and later sold, an electronic patient reported outcomes company. Earlier in his career, he established and managed the data management department for a mid-sized contract research organisation. David has also served as an independent consultant in the field of pharmaceutical technologies, and has co-developed several custom software packages.

 

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