New MHRA Guidance
Date: April 25, 2023
The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a Medical Device’.
This guidance provides access to important Software Group outputs that might be of assistance.
Find out more.
Explore More News

Regulatory Considerations DMEG Update – September 2024
The Regulatory Considerations DMEG are waiting for the release of ICH GCP E6 (R3) Annex 1 . . .
Read More

Digital Data Flow (DDF) integration through the lens of electronic Patient-Reported Outcomes (ePRO)
This article has been submitted by Leeni Joshua of ICON plc
Introduction:
Digital Data . . .
Read More

Guidance for Industry: Conducting Clinical Trials With Decentralized Elements
The Conducting Clinical Trials With Decentralized Elements final guidance has now been . . .
Read More

Welcome FGK Clinical Research as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome FGK Clinical . . .
Read More

Welcome LINK Medical as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome LINK Medical as . . .
Read More

Welcome Zilla Clinicals as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome Zilla Clinicals . . .
Read More

Challenge ChatGPT: CDMs vs AI
Following a recent Hot Topic discussion that explained how machine learning models are . . .
Read More

Welcome Boehringer Ingelheim as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome Boehringer . . .
Read More

Welcome Datacapt as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome Datacapt as a . . .
Read More

Welcome Climedo as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome Climedo as a . . .
Read More

Clinical Trials for Medicines – New Notification Scheme
The MHRA have recently launched a new notification scheme, the first step in their . . .
Read More

EMA Management Board: Highlights of October 2023 meeting
The EMA’s Management Board met on 5 October in Amsterdam. The article below covers the . . .
Read More