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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.