Formatting Annotated Case Report Forms (aCRFs): Part 1 Blog Post
Discover essential tips for formatting aCRFs with clarity and regulatory compliance in mind. Read the first blog in this series…
Regulatory Adoption Page
Regulatory Adoption in Drug Development Regulatory authorities worldwide trust Certara’s solutions for PK/PD modeling, biosimulation, and clinical data validation Learn more about Certara’s regulatory-grade solutions Contact us Meeting the highest...
Best Practices for Annotated CRFs Blog Post
In this webinar, Amy Garrett reviews published guidance from regulatory agencies and provides best practices for CRF annotations.
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Salvaging CNS Clinical Trials Halted Due to COVID‐19 Blog Post
The coronavirus disease 2019 (COVID‐19) pandemic has halted many ongoing central nervous system (CNS) clinical trials, especially in Alzheimer’s disease. These long‐duration trials involve many stakeholders, especially the patients and…
The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development Blog Post
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…
Understanding the Duplicate Records Validation Rules Blog Post
In this blog, we clarify the meaning & purpose of the duplicate records validation rules, then answer some FAQs about duplicate records.
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By leveraging quantitative models, regulatory expertise, and real-world data, we empower our partners to fast-track innovative therapies while meeting stringent regulatory standards.
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Certara’s Pediatric MIDD Accelerator advances efficient and reliable pediatric drug development processes that optimize dosing and get critical medicines to children faster.
