Certara Completes Acquisition of Pinnacle 21
PRINCETON, N.J., Oct. 04, 2021 - Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation,…
Simona ColucciOctober 4, 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
Controlled Terminology Best Practices
Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve…
CertaraMarch 3, 2021
Formatting Annotated Case Report Forms (aCRFs): Not Submitted Annotations and SDRG
Simplify aCRFs with insights on “Not Submitted” annotations, reviewer’s guide tips, and define origin column…
CertaraNovember 13, 2020
Preparing CDISC Submissions for China’s NMPA
China’s NMPA now accepts CDISC submissions. To support this initiative, Pinnacle 21 has released a…
CertaraOctober 30, 2020
Formatting Annotated Case Report Forms (aCRFs): Multiple copies and/or multiple versions of forms
Streamline aCRF formatting by mastering versions, repeated pages, and compliance essentials. Read the third blog…
CertaraOctober 9, 2020
New Pinnacle 21 Community Validation Engine: FDA (1907.2)
In August 2020, we released our new Pinnacle 21 validation engine “FDA (1907.2)” for preparing…
CertaraSeptember 13, 2020
Formatting Annotated Case Report Forms (aCRFs): Document properties, bookmarking and table of contents
Discover essential tips for formatting annotated CRFs, from dual bookmarking to document properties. Read the…
CertaraSeptember 10, 2020
Exploring Common CDISC ADaM Dataset Conformance Findings
What you need to know when validating your CDISC ADAM datasets During the regulatory review…
CertaraSeptember 3, 2020
