It’s great to see how different stakeholders in the industry can collaborate to improve clinical data management and look at data holistically.
FDA has a message for sponsors that want to incorporate mHealth technology into their clinical trials: as long as the technology can be clinically meaningful, don’t let us get in your way.
I recently attended a PhUSE (Pharmaceutical Users Software Exchange) Single Day Event (SDE) in Northbrook, Illinois, where industry colleagues shared their implementation experiences, what challenges they have faced and what lessons were learned. Presentations included the implementation of the Clinical Data Interchange Standards Consortium (CDISC) standards across the clinical data life cycle.
For someone like me, who preaches interoperability of eClinical systems, the DIA Annual Meeting is a rich opportunity to learn, explore interoperability opportunities and spread my message. I’ve recently been asked by both sponsors and leading clinical technology organizations why more sponsors aren’t integrating the various systems they use to manage and conduct their clinical trials.