Potential Challenges with FDA’s Multiregional Clinical Trials Guidance
October 14th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.
Ensuring Greater Access and Diverse Patient Populations
October 10th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.
The Use of Artificial Intelligence in Clinical Trial Enrollment
September 23rd 2024In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.
Aligning Decisions with Clinical Trial Timelines
September 19th 2024In an interview with Applied Clinical Trials Associate Editor Don Tracy, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial.
Navigating The New EU Clinical Trial Framework
September 13th 2024In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses new strategies that companies can implement to properly shift to the new EU clinical trial framework.
Impactful EU Clinical Trial Regulation Changes
September 12th 2024In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, offers her thoughts on what EU clinical trial regulations companies need to be the most aware of.
The Role of Collaboration in Achieving Greater Diversity in Clinical Research
August 23rd 2024In the third and final part of this conversation, Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara sheds light on industry collaboration and what elements of trial design have the greatest impact on diversity.