Cardiac Safety Research Consortium

Csrc’s educational programming and scientific activities provide support and resources for cardiac safety, education, and related tools to clinicians, patients, and researchers, and the public at large.

Use of artificial intelligence (AI) tools for cardiac safety assessment in clinical trials. Key AI areas include AI for cardiac safety & efficacy using AI to strengthen safety monitoring and efficacy assessments in cardiovascular trials, dual-purpose technology designing tools that work seamlessly in both clinical practice and clinical trial settings, validation & regulatory standards advancing biomarker qualification and drug development tools to ensure reliability in high-risk contexts, Human-in-the-Loop oversight defining clinician roles in AI decision-making while capturing efficiency….

Regulatory considerations for use of ePROs as cardiovascular endpoints. These include variability & disease coverage designing global PROs that account for cultural, linguistic, and disease-specific differences across patient populations, defining meaningful outcomes establishing consensus on what constitutes a substantive treatment effect, focusing on clinically relevant domains, rare disease validation tailoring ePRO strategies to the unique challenges and patient preferences in rare disease contexts, and wearables as anchors using digital health devices to capture real-time patient….

Cardiac Safety Research Consortium is a 501(c)(3) nonprofit (EIN 99-3066699) based in Narberth, PA.