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Implementing end-to-end trial technology solutions

Friday, September 1, 2017

While innovation in clinical trial technology can vastly improve processes and workflows, these technologies often create new challenges for sponsors and CROs—especially when the technologies are not compatible. The innovations are so diverse that sponsors and CROs have difficulty implementing comprehensive solutions. Interoperability is now more critical than ever.

One way to drive innovation is through legislation such as the 21st Century Cures Act, which encourages the development of new tools and efficiencies in trial design, adaptive design and software development, as well as an emphasis on patient-reported outcomes. Recent changes to ICH guidelines also focus on systematic oversight of trial risk and transparency into performance.

As a result of these types of innovation drivers, I predict that next-generation systems will be both multifunctional and unified. These new systems will cover multiple aspects of clinical trial operations, including electronic data capture, inventory management, payment systems, pharmacovigilance and clinical trial management systems. Furthermore, these disparate data sources will be integrated into one platform that will adapt to specific sponsor and CRO needs while meeting regulatory requirements.

I also anticipate that implementation of data aggregation platforms will increase and become more important to organizations. Although unified systems will continue to grow, there will still be significant diversity among technologies that provide different functions. By adapting data integration platforms, users will improve their data mining capabilities and gain visibility to analytics and insights from emerging data.

Over time, organizations will apply end-to-end clinical trial technology solutions to reduce costs and get their products to market faster. Sponsors and CROs will move toward unified systems that are intuitive for all users—ultimately resulting in faster trials, improved speed to market for medications and better, more patient-centric care.


Guest Contributor Greg Ambra is vice president of clinical operations at DZS Clinical Services, a full-service provider of clinical development activities, data analytic services and clinical staffing. He is the founder of InQuiry Research, a CRO acquired by DZS Software Solutions, which developed ClinPlus® eClinical trials software. Ambra brings more than 20 years of clinical research industry experience and has held strategic leadership positions in various sponsor and CRO companies. He earned his master’s degree in medical sciences from Boston University.

This article was reprinted from Volume 24, Issue 09, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns  focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact editorial@centerwatch.com. Subscribe >>

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