RACE for Children Act Opens New Avenues for Pediatric Oncology Drug Development

With the long-anticipated ignition of the Research to Accelerate Cures and Equity (RACE) for Children Act on Tuesday (August 18) this week, stakeholders in the development of oncology drugs—ranging from patients and their families to clinical research sponsors and practitioners—have new hopes for advancements in more effective therapies for pediatric cancers. According to Lynne Georgopoulos, … Continued

The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development

3 key tips to set your pediatric program up for success with the RACE for Children Act by Lynne Georgopoulos, RN, MSHS, RAC, Vice President, Regulatory Strategy at Certara On August 18, 2020, the Research to Accelerate Cures and Equity (RACE), which amends the Pediatric Research and Equity Act (PREA) comes into effect.  With the … Continued

Certara’s Best of the Blog 2019

A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.

A Beginner’s Guide to Performing Clinical Trial Simulation

The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different trial designs in silico before exposing patients to an experimental drug. In this blog post, I’ll explain how Certara’s Trial Simulator balances ease-of-use with robust … Continued

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