ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Advancements In Digital Health Applications In Clinical Trials

  Reflecting on the past year, take time to review the significant strides the digital health industry has made, especially in digital measures for clinical research.

• Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence

  A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.

• Responsible AI In Clinical Trials Starts With How It Is Designed

  Explore how trials can responsibly use AI to move faster while keeping human judgment, data protections, and auditability intact.

• How Site And Patient Research Optimizes Clinical Trials

  Signant’s patient and site research enhances digital health technology in clinical trials by optimizing usability and design. These insights drive improvements in product features, study designs, and training materials.

• Expedite Drug Development With An Integrated CDMO-CRO Model

  From optimizing first-in-human strategies to leveraging AI-enabled digital architectures, the integrated CDMO-CRO services model reduces risk and maximizes program value.

• Mitigating Study Risk With Performance Analytics

  Performance metrics for supporting risk-based management can be great, however, this author tells readers why collecting and analyzing data after a study has begun may not be the best approach.

• 4 Key eCOA Benefits To Speed Up Your Clinical Trial

  As the healthcare landscape moves towards a patient-centric approach, explore how sponsors and regulatory bodies look to eCOAs more and more for obtaining patient data.

• AI‑Readiness Checklist: Is Your Clinical Data Environment Ready?

  AI impact depends on solid data practices, good governance, and team alignment. This piece highlights what to assess and how organizations can build readiness for future initiatives.

• Implementing ICH E6 (R3) In A Risk Averse Culture

  Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

• The Regulatory Governance Gap In Clinical Trial AI

  Regulators are no longer questioning whether AI belongs in clinical trials; however, they’re demanding a governed infrastructure that makes every AI-driven decision auditable and defensible.