Everything you need to know about ILAP 2.0 White Paper ILAP 2.0 核心要点全解析 This white paper share’s key insights on the relaunch of MHRA’s Innovative Licensing and Access…Certara2025 年 5 月 19 日
Protect Confidential Information in Investigational Drug Submissions Blog Protect Confidential Information in Investigational Drug Submissions 2025 年 3 月 20 日 Health regulatory agencies require pharmaceutical companies to protect study participants’ personal information…Certara2025 年 3 月 20 日
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication HIV 病毒学抑制青少年中长效注射用 cabotegravir 与长效注射用 rilpivirine 联合用药的安全性研究(IMPAACT 2017/MOCHA):一项 1/2 期、多中心、开放标签、非比较性的剂量探索研究 The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…Danielle Pillsbury2025 年 3 月 20 日
EU CTIS: Europe’s New Clinical Trial Information System Blog EU CTIS: 欧洲新临床试验信息系统 The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…Certara2025 年 2 月 10 日
Anonymization vs. Redaction of Clinical Trial Data Blog 临床试验数据的匿名化与删减处理的对比分析 2025 年 1 月 17 日 The vernacular for disclosing pharmaceutical clinical trial results to the public may…Certara2025 年 1 月 17 日
Helping Sponsor Meet EMA Policy 0070 Requirements Case Study 帮助申办方满足 EMA Policy 0070 要求 The European Medicines Agency’s Policy on the Publication of Clinical Data for Medicinal Products for…Danielle Pillsbury2025 年 1 月 7 日
Streamlining the Preparation of 1-Year and 2-Year PSURs Case Study 简化 1 年期和 2 年期 PSUR 的准备工作 We explore how we helped one client deliver a last-minute addition to a Periodic Safety…Danielle Pillsbury2024 年 12 月 18 日
Delivering High-Quality, Timely Responses to EMA Safety Queries Case Study 及时对 EMA 安全性问题做出高质量回应 A pharmaceutical company approached us for support with eight safety-related queries from the European Medicines…Danielle Pillsbury2024 年 12 月 12 日
CMC Writing Support Helps Client Lift Clinical Hold Case Study CMC 写作支持帮助客户解除临床搁置状态 In drug development, Chemistry, Manufacturing, and Controls (CMC) regulatory writing plays a pivotal role in ensuring the…Danielle Pillsbury2024 年 12 月 10 日
A Medical Writer’s Guide to Collaborative Authoring Blog 医学撰稿人协作创作指南 Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…Certara2024 年 11 月 22 日