What 2025 could bring for psychedelic use in healthcare Blog Post
Explore the evolving landscape of psychedelic medicine, featuring updates from key players and insights on drug development best practices.
Unlock Global Regulatory Success: Overcoming Early Drug Development Challenges [APAC Webinar] Blog Post
Summary Navigating early drug development is critical to ensuring the long-term success of therapeutic candidates. This webinar explores key strategies to overcome common challenges, with expert insights from APAC and... From Research to Real-World Impact: A Model Informed Drug Development (MIDD) Framework to Support Understudied Populations Blog Post
Karen Rowland Yeo SVP, Client and Regulatory Strategy, Certara Dr. Karen Rowland Yeo is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. She has over two...
Certara Launches v12.0 of SEND Explorer Blog Post
December 18, 2024 Expanded visualizations and data standards support workflows for preclinical scientists and toxicologists Radnor, PA – December 18, 2024 – Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, announced...
CMS Cell and Gene Therapy (CGT) Access Model Explained: The Most Significant Drug Pricing Legislation You’ve Never Heard Of Blog Post
Caitlin Verrilli Matias Junghan December 13, 2024 The Centers for Medicare & Medicaid Services (CMS) is piloting a program that would negotiate and administer outcome-based agreements and supplemental rebates on...
CMC Writing Support Helps Client Lift Clinical Hold Blog Post
In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the quality and consistency of pharmaceutical products. The quality portion of a submission (such as an...
Key development considerations for cell therapies Blog Post
Rajesh Krishna, PhD Kathryn Brown December 5, 2024 What is a “cell therapy”? Nearly every recent oncology clinical conference has featured this phrase. Cell therapies, such as CAR-Ts (chimeric antigen...
GlobalSubmit 4.0 Webinars Blog Post
The world of electronic regulatory submissions is about to change with the introduction of eCTD (Electronic Common Technical Document) v4.0. This latest version of the standard includes updated specifications and guidelines for the preparation and submission of electronic regulatory documents.
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know Blog Post
Peggy Zorn December 3, 2024 The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for exchanging nonclinical drug development data. SEND was developed by the Clinical Data Interchange Standards...
Certara Showcases 2024 Research Wins with Over 100 Papers Published Blog Post
The company celebrates the 12 scientists included in the Stanford/Elsevier top 2% cited researchers list RADNOR, PA – December 2, 2024 – Certara, Inc. (Nasdaq: CERT), a global leader in…
