News & Insights
Clinical Trial Insurance and CTA Language: Protecting Sponsors Against Unintended Liability
When negotiating a Clinical Trial Agreement (CTA) and aligning with clinical trial insurance coverage, sponsors must carefully balance ethical obligations with the need to manage financial and legal risk. While
Audit & Inspection Provisions in Clinical Trial Agreements: Finding the Balance
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
Real-World Data in Clinical Trials: Unlocking Potential While Managing Risk
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 Not Overlook IP
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 on
Navigating the Future: How AI Is Changing Clinical Trial Agreement Negotiations
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 reviews
What Is a CRADA?
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 investigators,