News & Insights

Why These Provisions Exist Audit and inspection clauses in Clinical Trial Agreements (CTAs) are not “boilerplate.” They reflect the sponsor’s legal obligations under 21 C.F.R. § 312.50 (for drugs) and

Balancing Opportunity and Risk   Real-world data (RWD) has quickly become one of the most valuable tools in clinical research. Information drawn from electronic health records, insurance claims, patient registries,

  Why Sponsors Should Never Overlook IP Clauses in Clinical Trial Agreements When sponsors negotiate Clinical Trial Agreements (CTAs) with hospitals, universities, or research institutions, the immediate focus often falls

  As artificial intelligence (AI) continues to reshape the pharmaceutical and clinical research landscapes, one area undergoing rapid transformation is the negotiation of Clinical Trial Agreements (CTAs). From automating routine

  For sponsors and CROs exploring new sites for clinical research, Veterans Affairs (VA) hospitals are often overlooked—but they shouldn’t be. VA sites offer access to well-established infrastructure, highly experienced

Ask almost any clinical trial site or sponsor to name a major pain point in study operations, and you’ll likely hear the same answer: site payments.   Despite all the