-
On January 31st, 2025, the European Medicines Agency (EMA) reached another major milestone for the implementation of the Clinical Trials Regulation (CTR), the European Union’s (EU) current pharmaceutical legislation. The CTR has updated the many of the CTD policies; promoting communication between trials and regulators, increased transparency between trials and the public, and reducing financial and administrative burdens.
-
On April 4th, 2025, the U.S. Food and Drug Administration (FDA) updated their Institutional Review Board (IRB) Guidance Manual, part of the Bioresearch Monitoring (BIMO) Compliance Program. Staying up to date with these sorts of regulatory updates will help better prepare for inspections and give IRBs a chance to update any relevant protocols or policies that may not be compliant with these new changes.
-
On June 17th, 2025, the U.S. Food and Drug Administration (FDA) introduced its Commissioner’s National Priority Voucher (CNVP) pilot program to accelerate development of select drugs or biologics from companies that are supporting U.S. national interests and are aligned with U.S. national health priorities.
-
On June 4, 2025 the European Medicines Agency (EMA) posted a guideline titled: ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials. Individuals who are pregnant or breastfeeding make up a significant portion of the world’s population, however, the European Union (EU) reports that less than 0.4% of clinical trials currently submitted to the EU include pregnant people and only 0.1% include lactating individuals. This guideline highlights the importance of including these individuals as well as the steps that should be taken in order to ensure their safety during a trial.
Promeditec has developed a package that enables the user to carry out remote monitoring of clinical trials. Virtual On Site Monitoring (VOS) integrates high-cost traditional monitoring with an innovative method that leads to significant reduction in time and cost by eliminating the need for monitor relocation.
Monitoring clinical data is a critical part of trial success. Part of doing this effectively is efficiency, so a question being asked more frequently is “why not monitor source data remotely?” This course discusses the feasibility of remote monitoring of source data in compliance with predicate rules, including HIPAA, FDA, as well as mandates outside the US.
