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
Structural Similarity Methodologies for Small Molecules
Small molecule structural similarity metrics are important in a number of drug discovery workflows, such…
CertaraJune 13, 2024
Clinical trial data validation: When to transition from P21 Community to Enterprise
We compare P21 Community to P21 Enterprise for clinical trial data validation and answer the…
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
Ending the game of cat and mouse: The rise of structure-based generic definitions in Controlled Compound Legislation
Discover how the surge in generic drug legislation complicates identification of controlled compounds worldwide, and…
CertaraMay 14, 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
