P21 Adds Support for CDISC Open Rules Engine (CORE)
P21 is proud to announce that support for CDISC Open Rules Engine (CORE) is now available…
CertaraApril 25, 2022
Pinnacle 21 Releases P21 Community 4.0
As of April 25, 2022, we have released P21 Community 4.0 to general availability! Install…
CertaraApril 25, 2022
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials
Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…
CertaraApril 11, 2022
P21 Releases New PMDA Validation Engine
New PMDA Engine Pinnacle 21 is happy to announce the latest Validation Engine for submissions…
CertaraDecember 20, 2021
Industry Metrics for CDISC Controlled Terminology
Sergiy Sirichenko summarizes industry metrics across many studies and sponsors to produce an overall picture…
CertaraNovember 17, 2021
The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
CertaraSeptember 23, 2021
Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
CertaraSeptember 10, 2021
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…
CertaraSeptember 10, 2021
Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children
Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…
CertaraAugust 26, 2021
