Monthly Archives

August 2013

CluePoints Cited in New FDA Guidance

By | News

FDA

12 August 2013

Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that its CSM techniques currently patent-pending with the United States Patent and Trademark Office, that have been developed to improve data quality in studies, have been cited by the FDA in the recent release of the final guidance document detailing the agency’s stance on the “Oversight of Clinical Investigations”.…

New FDA Guidance Encourages Sponsors to Use Centralized Statistical Monitoring for Improved Data Quality

By | Blog | No Comments
[youtube=http://www.youtube.com/watch?v=1pxNwHQiFNY&feature=youtu.be]


Background

The recent release of the final guidance document detailing the FDA’s stance on the “Oversight of Clinical Investigations” is welcome news for the biopharmaceutical and medical device industry. The guidance clearly describes how central monitoring methodologies should be used, where appropriate, to oversee studies and effectively monitor clinical investigations to protect subjects and enhance the quality of research.…