Clinical Trials


Clinical Disclosure in 2026: How Misalignment Impacts Company Valuation and Litigation Risk

 
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Consistent, AI-verifiable clinical and SEC disclosures are now essential to protect valuation and avoid litigation. Misalignment creates measurable regulatory, financial, and legal risk, while disciplined, synchronized disclosure strengthens credibility and reduces exposure.

Introducing Citeline’s Disclosure Alignment Risk Index: A Framework To Measure Trial Transparency

 
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DARI is an AI enabled framework that scores how well clinical trial disclosures align across SEC filings, registries, press releases, and presentations, identifying risks in timing, accuracy, consistency, governance, and tone to flag regulatory or litigation exposure.

Predictable Yet Flexible: Sponsor-Driven Timelines Underpin UK’s New Clinical Trials Regime

 
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The UK MHRA says it is ready to deliver the new Clinical Trials Regulation, which aims to balance faster review of trial applications with greater flexibility to deliver a competitive, innovation-friendly clinical research ecosystem.

EMA Targets Inconsistent Cardiovascular Toxicity Assessments In Oncology Trials

 

The European Medicines Agency wants feedback on a reflection paper that aims to address a lack of “uniformity” in cardiovascular toxicity endpoints in clinical trials for cancer drugs.