Adopting CDISC Standards: Our Journey With CDISC Blog Post
In this case study, we explore our 23-year partnership with CDISC and we look at a number of collaborative projects.
Clinical Trial Design Page
Create collaborative, compliant clinical trial designs with Pinnacle 21 Enterprise.
Regulatory Affairs Consulting Page
Strategic guidance and end-to-end support to navigate global regulatory pathways, ensuring efficient and compliant drug development from preclinical stages through market approval.
Certara Drug Development & Regulatory Experts Achieve 100th Rare Disease Submission Blog Post
Dedicated team of global regulatory experts drives the approval of rare disease treatments RADNOR, Pa. — October 1, 2024 – Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug…
Phoenix WinNonlin Page
A trusted solution for pharmacokinetic, pharmacodynamic, and non-compartmental analysis.
How to Use CDISC’s ODM Standard for CRF Design Blog Post
Over the last decade, our industry has become familiar with Clinical Data Interchange Standards Consortium (CDISC) standards. This has largely been driven by regulation, with national regulators such as FDA…
How Clinical Trial Technology Streamlines the Research Process Blog Post
Learn how innovative clinical trial technology helps to revolutionize research & ensure the swift rollout of safe and effective treatments.
Certara’s Simcyp Consortium Celebrates 25th Anniversary Blog Post
The pre-competitive scientific research consortium of top pharmaceutical companies remains a critical force in advancing qualified PBPK modeling and simulation to further drug development and regulatory decisions RADNOR, PA –…
Why cancer drug programs need human mass balance studies Blog Post
Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies in the clinical pharmacology package. This omission stems from the ICH S9 on nonclinical evaluation…
Certara Launches Early Development Solution to Reduce Failure Rates in Early-Stage Drug Development Blog Post
New solution offers early-stage developers a dedicated team of experts with combined experience in end-to-end drug development to optimize delivery timelines, derisk programs, and improve outcomes. RADNOR, PA – SEPTEMBER…
