Blog Archives

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What is a Scientific & Medical Publications Professional?

Would your drug development program benefit from partnering with experts in scientific and medical communications…

CertaraJuly 19, 2024

Blog

Pinnacle 21 Enterprise Analytics: Case Studies from the Field

In this blog, we look at some examples of how Pinnacle 21 Enterprise Analytics (P21E)…

CertaraJuly 15, 2024

Blog

Drug Discovery Platform Unlocks Scientific Data Access

The D360 desktop application supports drug discovery workflows, data access, and early development research data…

CertaraJuly 12, 2024

Blog

3 Things You Should Know About ADaM Standards

Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and…

CertaraJuly 4, 2024

Blog

Categorizing & Managing Risks in Aggregate Safety Reports

Categorizing Risks From a sponsor’s first authorization to conduct a clinical drug trial in any…

CertaraJune 28, 2024

Blog

Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?

June 27, 2024 Advances in technology and changes to the regulatory environment have resulted in…

CertaraJune 27, 2024

Blog

Generative AI Tools for Regulatory Writing

Regulatory writing is a crucial component of the drug development process. Regulatory writers must understand…

CertaraJune 20, 2024

Blog

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

Blog

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

Blog

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

Blog

What is a Scientific & Medical Publications Professional?

Pinnacle 21 Enterprise Analytics: Case Studies from the Field

Drug Discovery Platform Unlocks Scientific Data Access

3 Things You Should Know About ADaM Standards

Categorizing & Managing Risks in Aggregate Safety Reports

Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model?

Generative AI Tools for Regulatory Writing

ICH M12 Guidelines & Your Drug-Drug Interaction Package

Using Real World Data in Clinical Trial Submissions

Clinical trial data validation: When to transition from P21 Community to Enterprise

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