One Week Left for CTIS Mandatory Use Date
EMA reminds the clinical trials community that the Clinical Trials Information System will be mandatory at the last day of this month.
On January 31, 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trials applications and will serve as the single-entry point for submission by sponsors and for regulatory assessment. The EMA reiterated this deadline and updated the community on the current status of the system, which has been in transition for one year.
Read additional information from the EMA.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
