Regulatory

In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.

Industry leaders share their thoughts on the NIH funding cuts and how they are impacting clinical research.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how trial design and timelines could be impacted by a potential mandate for placebo use across all vaccine trials.

An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.

How today’s SSO reduces site burden and spearheads clinical system interoperability.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, shares his key takeaways from Cencora’s recent TMF Leadership Summit and touches on the importance of oversight when working with outside stakeholders.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses how risk-based approaches must be prioritized amidst the increased demand for quality and compliance.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, highlights recent ICH guidelines and how risk should be an area of focus as trial designs continue to get more complex.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses challenges the TMF space is currently facing and how it can utilize collaboration in making advancements.

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, highlights the Rally for Rare event and how it succeeded in providing the community a space for collaboration and innovation.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses the most prominent challenges he is seeing in the space right now including competing research priorities and finding endpoints.

Examining the implications of the recent US executive orders concerning diversity, equity, and inclusion pursuits—and the key questions each clinical trial stakeholder must now navigate.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights the need for maintaining data privacy in a highly regulated clinical research industry.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, talks the current landscape of sustainability in clinical trials and how stakeholders are beginning to pay more attention to carbon footprint amid increasing protocol complexity.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights where regulatory agencies currently stand on sustainability in clinical trials and how pharma companies are looking to reduce their carbon footprint.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), highlights how research communities have self-organized in light of recent changes.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how companies in the clinical research industry have been responding to recent political headwinds.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses how the current political climate is affecting diversity in clinical research and how diversity action plans may be impacted.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), shares his thoughts on the recent funding cuts made by the NIH and how they are impacting medical research.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, talks innovation in clinical technology and how the FDA can continue to promote its adoption.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, discusses the need for change in the clinical research industry and how the adoption of new technology can increase operational efficiency.

In this video interview, Iddo Peleg, CEO and co-founder at Yonalink, shares his thoughts on the current climate of clinical research following NIH funding cuts and the removal of FDA diversity guidelines.

Webinar Date/Time: Tuesday, April 1, 2025 at 11:00 AM EST

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, talks FDA’s latest protocol deviation guidance and potential changes to the draft.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, highlights FDA’s recent protocol deviations guidance and how it reinforces previous recommendations from industry.

In this video interview, Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the new guidance and its level of detail on the different types of protocol deviations.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Rajneesh Patil, vice president, digital innovation, IQVIA, highlights the impact of artificial intelligence/machine learning in improving outcomes and maintaining safety with its implementation.

Recent actions by the FDA and NIH in response to the current political climate have left key stakeholders in clinical trials with limited resources to conduct equitable research.