Regulatory

Case study highlights how clinical operations teams can overcome complex regulatory and operational hurdles to finish a trial on time and on budget.

Despite positive results from a Phase I/II trial of its investigational pandemic influenza vaccine, mRNA-1018, Moderna’s award for almost $600 million to accelerate vaccine development will be terminated.

In this video interview, Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discusses the administration’s policy and how it could force pharma companies to reduce funding for clinical R&D.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines.

In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

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.