AUSTIN, Texas--(BUSINESS WIRE)--CDISC today announced an expansion of its offerings with the official affiliation of volunteer-based Trial Master File (TMF) Reference Model Group. The combined ...
The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were officially signed into law on 10 April 2025, marking a significant development in the UK clinical trials framework (the ...
The collaboration intends to improve clinical development outcomes by reducing amendments and costs while expediting market ...
Amgen has entered a partnership to use Veeva Systems’ comprehensive Clinical Platform to enhance trial processes. This collaboration also aims to advance innovation in clinical trials and expedite the ...
Unintegrated technology is slowing down clinical trials. Twenty-two percent of Phase III clinical trials fail—not because the drug is found to be unsafe or ineffective but because the trials last so ...