Certara Announces Launch of Pediatrics Practice with Scientific and Regulatory Experts

Combination of experts and software helps accelerate pediatric drug development and increase clinical trial success rates PRINCETON, NJ – July 29, 2020 – Today, Certara®, the global leader in biosimulation, launches Certara Pediatrics, a new practice area to help biopharmaceutical companies apply model-informed drug development to their pediatric programs and better navigate the changing regulatory landscape. … Continued

Considerations for Management of Clinical Trials and Regulatory Filing Strategy in Light of COVID-19

COVID-19 has the potential to negatively impact critical activities such as patient recruitment, patient safety and ensuring data integrity. Thus, clinical developers should review their planned regulatory filing strategies to determine if modifications are required. Attend this webinar to learn mitigation strategies and best practices that you can begin implementing now. Speakers: Demetrius Carter, SVP … Continued

Diving into Best Practices for Pooling Clinical Trial Data

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated … Continued

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