Medical device companies face pipeline and development challenges similar to those of pharmaceutical companies, but with unique needs in planning and conducting clinical trials that are often overlooked. Device protocols must be coordinated with manufacturing and supply availability, and the data management challenges of assimilating visit-based follow-up with ongoing endpoint data collection must be considered when deploying trials.
Medical device companies' operational necessities in clinical trials create significant opportunities for increased efficiency today. Medidata Rave® provides additional value to industry leaders with a platform on which to build their competitive advantage.
Medidata Designer® can assist in the development of the research protocol, and insure the data elements encompassed in the protocol are accurately reflected in downstream trial systems, including clinical trial management systems used to track device supplies and manufacturing. Medidata trial benchmarking products—Medidata Grants Manager® and Medidata CRO Contractor®—provide detailed information using other companies as comparators.
Medidata Rave's capabilities for the capture, management and reporting of device trial data provide sponsors with insight into their clinical data, and the Rave clinical services platform offers an ideal central system that seamlessly connects multiple sources of study data (including core labs and IVRS). By managing all their studies in Rave's enterprise architecture, medical device companies can cost-effectively manage long term monitoring of device trial subjects within a single system.