Synchrogenix Acquires ClinGenuity
Certaa announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity.
Certara®, a global biosimulation technology-enabled drug development and drug safety consulting company, announced that its regulatory and medical consultancy, Synchrogenix, has acquired ClinGenuity, an artificial intelligence-assisted medical writing service for the pharmaceutical industry. Their combined team now includes more than 200 regulatory and medical writers with expertise in document development for the U.S. Food and Drug Administration, European Medicines Agency (EMA), and other global regulatory organizations. This move, in part, addresses the new European and U.S. clinical trial data transparency initiatives – such as EMA Policy 70, which goes into effect this month– are creating additional disclosure compliance requirements for pharma and biotech companies. For example, they will now need to redact and de-identify datasets in their clinical study reports and submission documents, produce research summaries suitable for a lay audience, and publish their clinical study information publicly.
Read the full release here.
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.
