Even though there is now much regulatory support for eConsent, and a guidance issued by the FDA which became official at the end of 2016, there are still challenges internationally with eConsent adoption. Because the consent process captures Personal Health Information, it is subject to many international regulations for data capture and storage including electronic signatures.
Medidata has used their extensive eConsent experience to guide their current regulatory approach and has a large workstream effort to work with regulatory authorities in multiple countries for adoption. In addition, they are working with large IRBs and the FDA in the US to transfer US based guidance to other countries to speed adoption. There is no silver bullet, and the ultimate answer is that the goal state will be achieved through a combination of changes in policy, program, and data collection.
Join Medidata eConsent Expert Michael Tucker to learn:
- The current state of eConsent globally
- A brief history of eConsent adoption to date globally
- Recent EMEA inspectors meeting outcomes and Swedish comments
- The ideal future state of eConsent
- Steps needed to get to that future state - what the industry response should be
Michael Tucker
Senior Product Solution Specialist Mobile Health, Medidata
Michael recently joined Medidata through the acquisition of Mytrus, a leading eClinical startup which has pioneered eConsent and virtual trial technologies in clinical research. Michael is an authority on the use of eConsent and virtual trials and has been instrumental in introducing mobile technologies into global biopharmaceutical, medical device, educational and government organizations as well as building strong alliances with CROs and other partner organizations.
Michael's 30 years of experience in medical research has included executive management roles in business development, sales, and client services for pre-clinical and clinical research organizations.
- The current state of eConsent globally
- A brief history of eConsent adoption to date globally
- Recent EMEA inspectors meeting outcomes and Swedish comments
- The ideal future state of eConsent
- Steps needed to get to that future state - what the industry response should be
- Clinical Operations
- Data Management
- Innovation/Transformation
- Digital
- CIO
- Portfolio Innovation
- IT
