Regulatory

While randomization is required by regulatory bodies, it is up to the sponsor on how to conduct it.

How digital intake solutions driven by technological advancements can help overcome the challenges of operating across different regulatory markets.

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.

In this video interview, Michael Liu, discusses the need for continued monitoring of these medical research cuts to gain a better understanding of exactly what trials they are impacting.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, highlights key findings from a recent breakdown of funding cuts and how they are impacting research institutions.

In this video interview, Michael Liu, medical student and researcher at Harvard Medical School, discusses a recent study he conducted on the characterization of research funding cuts.

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 clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, highlights how patients’ perspectives on vaccine trials may shift if a policy change was to take place.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, talks patient recruitment and retention in vaccine studies as well as how behavioral, analytical tools can help patient support.

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.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

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.