Clinical Trial Regulations

Navigating the complex landscape of clinical trial regulations in the European Union can be daunting, especially under the evolving framework of the EU Clinical Trials Regulation (CTR 536/2014). CHDR provides your essential guide for mastering this process. Designed for sponsors, researchers, and biotech innovators, this brochure provides a clear, practical breakdown of regulatory timelines, submission procedures via the Clinical Trials Information System (CTIS), and the legal obligations for both EU and non-EU sponsors.

Whether you’re planning a trial involving investigational medicinal products or conducting clinical trials without IMP under national laws like the Dutch WMO, CHDR outlines every critical step. Gain insight into CHDR’s unique strengths, including streamlined timelines, established ethics partnerships, and their ability to serve as your legal representative within the EU. Packed with FAQs, process charts, and expert recommendations, this document equips you with the knowledge to accelerate your clinical trial approval, reduce risk, and meet all regulatory expectations confidently.