Generative AI Tools for Regulatory Writing
Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand…
CertaraJune 20, 2024
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
CertaraJune 19, 2024
Using Real World Data in Clinical Trial Submissions
We explore challenges & best practice recommendations to help you implement submission standards when using…
CertaraJune 17, 2024
Clinical trial data validation: When to transition from P21 Community to Enterprise
Technology is designed to help us live and work smarter. That is exactly what P21’s…
CertaraJune 7, 2024
The Future is Now: Virtual Clinical Trials Transforming Drug Development
Welcome to the forefront of drug development innovation! The drug development landscape is rapidly evolving,…
CertaraJune 4, 2024
Phoenix UGM 2024: A Day of Innovation and Collaboration
The Phoenix UGM featured industry expert insights, peer networking, and glimpses into the latest PK/PD…
CertaraMay 31, 2024
Demystifying CDISC, SDTM, and ADaM
Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…
CertaraMay 22, 2024
Leveling Up SDTM Validation with the Magic of Data Managers
In this abstract, Julie Ann Hood and Jennifer Manzi look at how you can improve…
CertaraMay 19, 2024
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates
In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…
CertaraMay 10, 2024
Why are Clinical Data Standards Essential for EDC and Non-EDC Data?
Clinical data standards are essential for both EDC & non-EDC data. Learn how study build…
CertaraApril 25, 2024
