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. このウェビナーでは、一般的に直面する課題を克服するための主要戦略について、アジアとアメリカの専門家の見識を交えて解説していきます。... 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
2024年12月18日 Expanded visualizations and data standards support workflows for preclinical scientists and toxicologists Radnor, PA – 2024年12月18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 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 2024年12月13日 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 2024年12月5日 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
eCTD（電子化コモン・テクニカル・ドキュメント）v4.0の導入により、電子規制申請の世界は大きく変わろうとしています。本規格の最新版には、電子規制文書の作成および提出に関する仕様とガイドラインの更新内容が盛り込まれています。
CDISC SEND V3.1.1 Updates Nonclinical Drug Developers Need to Know Blog Post
Peggy Zorn 2024年12月3日 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
サターラの科学者12名が、スタンフォード大学／エルゼビアによる世界上位2％の被引用研究者リストに選出米国ペンシルベニア州ラドナー – 2024年12月2日– サターラ社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…
