The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January. The revision ...

"Two steps forward, one step back," laments an old proverb, describing the all-too-common tendency of progress to come paired with unexpected setbacks. Take, for instance, clinical trials regulations ...

Innovation is not just a luxury but a necessity in the realm of clinical trials, particularly as we strive to accelerate drug development. Yet, the slow pace of innovation within the U.S. clinical ...

DUBLIN--(BUSINESS WIRE)--The "EU (European Union) Clinical Trial Regulation 536/2014: Overview and Implementation Experience Training Course" conference has been added to ResearchAndMarkets.com's ...

Pharmaceutical companies, researchers, and patient groups are raising concerns about new European Union regulations that could hinder the development of treatments for rare diseases. The new rules, ...

As part of a lifecycle IP strategy for a therapeutic product, it can be important to protect inventions arising during the clinical development of the product. Disclosures made during the clinical ...

Faced with growing dominance from China, governments are transforming clinical trial frameworks to boost R&D activity.

Innovations in clinical trial designs and tools have the potential to unlock a new era of research that is more convenient for patients, more reflective of real-world treatment conditions, and more ...

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to ...