Catalyzing DMTA Information into Insights Blog Post
Drug discovery is a data-driven research process that requires accurate data capture, ample and reliable data storage, and real-time data analysis. Timely access to all compound data is essential for…
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...
Generative AI Tools for Regulatory Writing Blog Post
規制関連文書の作成は、医薬品開発プロセスの重要な要素です。規制文書作成者は、科学的な概念や最新の規制・ガイドラインを理解し、それに準拠した文書を作成する必要があります。続く…
RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind Blog Post
EMA Policy 0070 is a main driver for clinical trial data anonymization. This regulation requires publishing clinical data in regulatory submissions of investigational drugs. This policy aims to increase the…
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。
Case Study. Enhancing HEOR Global Knowledge Sharing Blog Post
The Global Health Economics and Outcomes Research (HEOR) team of a leading global healthcare company in the pharmaceutical industry was facing significant challenges in distributing extensive training materials across various...Celebrating Certara’s 10th Annual Kraków HTA Symposium Page
Celebrating Certara’s 10th Annual Kraków HTA Symposium With over 100 attendees, the 10th Annual HTA Symposium, held in Kraków May 20-21, brought together a diverse group of stakeholders, including representatives...
How a top 10 pharma fought the rising tide of non-CRF data Blog Post
大手製薬会社が Pinnacle 21 Data Exchangeを使用して、CRF以外のデータ管理を自動化し、リソース使用量を 80%削減し、申請までの期間を短縮した事例をご覧ください。
