3 Things You Should Know About ADaM Standards Blog Post
Learn the key aspects of ADaM standards, including the difference between SDTM and ADaM and the importance of traceability.
University of Florida Wins 2023/24 Certara-Simcyp™ Grant and Partnership Scheme Blog Post
RADNOR, PA — 2024年7月3日 – Certara, Inc. バイオシミュレーションのグローバルリーダーであるサターラ（Nasdaq：CERT) はCERT), a global leader in biosimulation, is pleased to announce that the University of Florida has been awarded the prestigious…
Future Clinical Study Design: CDISC, FHIR, OMOP, or Hybrid Model? Blog Post
Jeffrey Abolafia 2024年6月27日 Advances in technology and changes to the regulatory environment have resulted in a change in drug applications, from being comprised of a collection of randomized...
ICH M12 Guidelines & Your Drug-Drug Interaction Package Blog Post
ICH M12 薬物相互作用ガイドラインの主な変更点の概要と、すぐに参照できる要約表をご提供しています。
Joint Clinical Assessment (JCA) And Potential Consequences For The Evaluation Of Gene Therapies Blog Post
In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. It is the only topical retinoid that selectively targets retinoic acid...
Using Real World Data in Clinical Trial Submissions Blog Post
We explore challenges & best practice recommendations to help you implement submission standards when using Real World Data in clinical trials.
Adaptive Trial Design for Phase 1 Dose-Finding Studies Blog Post
Greater flexibility, efficiency and quicker dissemination of research findings to patient communities that stand to benefit are all potential advantages of adaptive trial design as compared to more conventional methods…
Clinical trial data validation: When to transition from P21 Community to Enterprise Blog Post
Technology is designed to help us live and work smarter. That is exactly what P21’s Community and Enterprise applications were designed to do – to help study teams collect, transform,…
The Future is Now: Virtual Clinical Trials Transforming Drug Development Blog Post
Welcome to the forefront of drug development innovation! The drug development landscape is rapidly evolving, and we’re excited to introduce you to the concept of the “parallel virtual universe.” This…
