07.10.25 -- EMA Guideline On Clinical-Stage ATMPs Comes Into Effect

Explore the ICH E17 guidelines that provide a harmonized framework for designing and conducting multiregional clinical trials (MRCTs) to meet the regulatory expectations of multiple regions.

Learn the distinctions between a Waiver of Consent and a Waiver of Written Consent in clinical trials, and the importance of informed consent, particularly in the context of virtual trials.

Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

Regulatory bodies like the FDA and EMA now prioritize real-world data in clinical research. Learn more about its value in enhancing drug development, regulatory decisions, and patient outcomes.

Learn how to identify common CRO selection pitfalls and apply expert-backed strategies to protect your clinical program from costly risks and delays.

Gain valuable insights into advanced methods and analysis techniques for high-order structure, physiochemical characterization, cell-based and biochemical assays, and more.

A CDMO with the right team of experts can aid drug development, regulatory compliance, and clinical trial supply, accelerating timelines to first human dose clinical trials and the path to market.

From complex study designs and evolving regulations to time-sensitive treatment protocols, advancing oncology clinical trials present significant challenges for investigators, sites, and patients.