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Client Alerts 4 results
Client Alert | 6 min read | 05.11.26
FDA’s AI in Early Phase Clinical Trials RFI: An Opportunity to Help Set the Rules of the Road
Consistent with recent FDA initiatives directed at leveraging AI technologies and improving early-phase clinical trial conduct, the FDA has issued a Request for Information (RFI) for input on a proposed AI-enabled optimization pilot program for early-phase clinical trials. The issues for which FDA is requesting information fall into two categories: (A) Pilot program design and implementation and (B) Program evaluation metrics and success criteria.
Client Alert | 4 min read | 05.04.26
Decentralized Clinical Trials: Key Sponsor Considerations Under FDA and EMA Guidance
The FDA and the European Medicines Agency (EMA) (jointly with the European Commission and Heads of Medicines Agencies) each have issued or updated their respective guidance addressing decentralized clinical trials (DCT), i.e., clinical trials that include trial-related activities conducted at locations other than the traditional investigative site.
Client Alert | 3 min read | 03.02.26
Clinical trial sponsors and all other stakeholders involved in conducting commercial clinical trials of investigational medicinal products (IMP) in the UK.
