Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey Case Study 臨床試験デザインの標準化で大きな夢を描く - あるバイオ製薬会社のメタデータ自動化への道のり This case study explores how one biopharma gets deeper insights & more informed decision making…Simona Colucci2024年5月13日
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates Blog Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…Certara2024年5月10日
Why Medical/Regulatory Writing Services Use Style Guides & Lexicons Blog Why Medical/Regulatory Writing Services Use Style Guides & Lexicons Learn how style guides and lexicons help medical writers produce clear, consistent, and accurate content…Certara2024年3月18日
Best Practices for a Successful eCTD Submission Blog eCTD申請を成功に導くベストプラクティス Learn common pitfalls that pharmaceutical sponsors encounter during the regulatory eCTD submission procedure and best…Certara2024年3月5日
Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Blog Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues…Certara2023年12月12日
10 Things to Know About eCTD 4.0: Embracing the Future Regulatory Submissions Blog eCTD 4.0について知っておくべき10のこと:今後の規制当局への提出 In this blog post, we explore the top 10 things you need to know about…Certara2023年10月17日
Maximizing Reusability for Drug Submissions to Different Health Authorities Blog Maximizing Reusability for Drug Submissions to Different Health Authorities Many drug developers have products that they want to submit for marketing approval in several…Certara2023年9月21日
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise Advances Sarcoidosis Drug Program Case Study 薬物動態モデリングおよび科学的コミュニケーションの専門性を活用することで、サルコイドーシス治療薬開発プログラムの前進に貢献 Certara's support, from dose optimization to medical writing, helps pharmaceutical companies advance their research, make…Danielle Pillsbury2023年6月1日
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Case Study Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that…Danielle Pillsbury2023年4月17日