Certara, Paidion Research Form Pediatric Drug Partnership
Certara® and Paidion Research, announced a new partnership to address the challenges inherent in pediatric drug development.
Certara®, a global biosimulation technology-enabled drug development company, and Paidion Research, a pediatric clinical research organization (CRO), announced a new partnership to address the challenges inherent in pediatric drug development including safe and effective dose or dose ranges and the conduct of trials. The partnership joins together Certara’s Simcyp® Pediatric PBPK simulator to inform the dose selections, with Paidon’s neonatal and pediatric intensive care unit and pediatric clinical site networks and clinical trials experience.
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.
