Navigating the regulatory labyrinth of technology in decentralised clinical trials

It can be challenging to keep up to date with new regulations governing the technology and data in decentralised clinical trials (DCTs).

While there are no globally applied DCT-specific regulations and the technology tools required to conduct them need to be customised for each trial, there are a series of regulatory guidance documents that have been issued by the European Medicines Agency, the U.S. Food and Drug Administration and selected countries, that form the current regulatory framework for DCTs.

However, given that DCT-specific regulations that can be applied globally are lagging, sponsors should be aware of the challenges that they may face from a regulatory, legal, and operational perspective when designing and operationalising their DCTs.

In this whitepaper, we explore:

• The varying regulatory and legal jurisdictions across countries that may restrict the use of certain DCT services or technologies
• The level of intelligence required to stay on top of the evolving regulatory environment
• Insight into regulation on eConsent and BYOD
• Practical guidance on the use of digital health technologies
• Applicable privacy laws relating to data
• Considerations in capturing and managing data in DCTs.