Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Digital Transformation Of Clinical Trials Is Shared Responsibility, CRO Industry Says

Executive Summary

Digitizing data collection and monitoring has taken longer than desired due to various challenges, including resistance to change, unanticipated burdens and trial complexity, officials from ACRO and Medidata say, countering US FDA Commissioner Gottlieb’s criticisms that CRO business practices are holding back change.

You may also be interested in...



Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.

Clinical Trial Sponsors Should Consider Changing Data Collection Amid COVID-19, US FDA Says

Quarantines, travel restrictions and supply chain interruptions are likely to cause "unavoidable protocol deviations" in ongoing clinical trials, the FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by COVID-19.

Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough

Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124371

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