Adopting CDISC Standards: Our Journey With CDISC Blog Post
本ケーススタディでは、CDISCとの23年間のパートナーシップを探り、いくつかの共同プロジェクトを紹介します。
Regulatory Affairs Consulting Page
世界各国の薬事規制対応を成功に導くための戦略的ガイダンスとエンドツーエンドのサポートを提供し、前臨床から上市までの効率的かつコンプライアンスに準拠した医薬品開発を保証します。
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. — 2024年10月1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…
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
これまで、がんやその他の進行が速く致死的な疾患に対する薬剤開発プログラムでは、臨床薬理パッケージにマスバランス試験が含まれていないことが一般的でした。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…
