Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

International Trial Organizations Address Reporting Of Unforeseen Disruptions

Executive Summary

Drawing on lessons learnt from unprecedented interruptions to clinical trials over the past few years due to such things as the pandemic and the war in Ukraine, new advice has been issued on adjustments needed in clinical study reports to document these disruptions. 

You may also be interested in...



Global Medtech Guidance Tracker: November 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape

The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.

Qualifying Digital Biomarkers ‘Much Easier Now’ Thanks To EMA Efforts

The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147034

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel