Everything you need to know about ILAP 2.0
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
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
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
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
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
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
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
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
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
Once upon a time, regulatory writing for drug development programs followed a scheduled routine and…
Certara2024 年 11 月 22 日
