Complex Biologics Page
Certara’s Complex Biologics Services provide advanced support for CAR-T, monoclonal antibodies gene therapies. Trust our expertise to navigate regulatory pathways and enhance success.
Formatting Annotated Case Report Forms (aCRFs): Document properties, bookmarking and table of contents Blog Post
Discover essential tips for formatting annotated CRFs, from dual bookmarking to document properties. Read the 2nd blog post in this series.
Exploring Common CDISC ADaM Dataset Conformance Findings Blog Post
What you need to know when validating your CDISC ADAM datasets During the regulatory review process, it’s critical to have analysis data that complies with CDISC’s ADaM standard. Both the…
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…
Application of PK/PD Modeling and Simulation in Drug Discovery and Development in China Blog Post
By Yuancheng Chen, Research Associate of Phase 1 Unit, Huashan Hospital, Fudan University, and visiting scholar of Uppsala University Certara recently held its first virtual Phoenix User Group meeting in…
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...
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.
Pediatric Practice Page
Certara’s Pediatric MIDD Accelerator advances efficient and reliable pediatric drug development processes that optimize dosing and get critical medicines to children faster.
Mapping Considerations for Screen Failure, Not Assigned, and Not Treated Subjects Blog Post
In this blog, we clarify the best practices when mapping data for screen failure, not assigned, and not treated subjects.
