Topic

Articles

The data, not the plan, provide the direction. 

Data Integration Strategy: The Cornerstone Of A Successful Regulatory Submission

Developing new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.

The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment Considerations

FDA emphasizes importance of inclusion in trials.

Diversity in Clinical Trials Gains Ground Amidst COVID

President unveils lengthy program for combatting COVID-19 immediately following inauguration.

Biden Pandemic Plan Highlights R&D Support

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Cancer still a primary focus of EMA in light of COVID and vaccine development.

EMA’s Cooke Reviews European Cancer Prospects

Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.

Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?

Researchers aren't taking full advantage of advances in trial technologies. A lack of clarity in the current version of the International Council for Harmonization "Guidelines for Good Clinical Practice", could be the problem. 

Clinical Trial Evolution: The Drive to Update ICH E6

Recent webcast addresses what organizations can do to prepare for the next revision of ICH E6.

E6 (R3) on Horizon

Looking back on regulatory challenges created by COVID in 2020.

Pandemic Shines Spotlight on Clinical Trial Conduct and Regulation in 2020

COVID-19 pandemic forces compliancy within organizations following FDA’s 2018 revision of Good Clinical Practice in federal registry. 