SPOTLIGHT -
Regulatory Considerations for Digitally Driven Trials
Tech companies entering space must adapt and adhere to regulations set by FDA.
Clinical Trial Technology: New Kids on the Block are Changing Industry Dynamic
COVID has accelerated to the scene upstart digital efforts to transform patient engagement and data management/integration—but progress remains measured.
Quantifying Protocol Deviation Experience by Clinical Phase
Study uncovers pre-pandemic deviation levels.
Administering Complex Cognitive Tests Remotely in The Cognitively-Impaired
Pandemic aside, remote solutions are advancing care in clinical trials.
Assessing Use of Data Integration and AI In Clinical Trials Today
Martin Gouldstone, Global SVP, business development, Owkin, speaks to ACT on the use of AI in data practices and approaches for clinical research, and the distinction of “ethical AI."
School’s Out for Summer, But Learning Continues
Pandemic trends set stage for upcoming DIA Global Annual Meeting.
Applied Clinical Trials June 2022 Issue (PDF)
Click the title above for a link to open the Applied Clinical Trials June 2022 issue in an interactive PDF format.
New Guidelines Aim to Advance Pediatric Drug Development
ICH draft guidance proposes standardized framework for identifying ways development programs for adult treatments can inform pediatric studies.
Report Admonishes EMA Efforts to Reform Trial Transparency
Just-released analysis by Prescrire contends that the agency “is backtracking on commitments to clinical data transparency.”
Defining Quality Tolerance Limits and Key Risk Indicators that Detect Risks in a Timely Manner: Reflections from Early Adopters on Emerging Best Practices (Part 1)
Series Part 1—Introduction and the relationship between QTL and KRI.
Pandemic Challenges and Opportunities for Gender Equity in Clinical Research
Industry must act now to minimize effects of COVID-19 on clinical research.
