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Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...

Sharan Murugan
Jun 26, 20211 min read


Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA
This is a DRAFT GUIDANCE distributed for comment purposes only. This guidance provides recommendations to sponsors for the collection of...

Sharan Murugan
Jun 19, 20211 min read


FDA’s New Draft Guidances on Device Postmarket Surveillance – For Comments
The US Food and Drug Administration (FDA) has issued draft guidance to help Medical Device Manufacturers comply with postmarket...

Sharan Murugan
Jun 11, 20211 min read
