by Don McLean | Jun 29, 2020 | Blog
Whitepaper: Pharmaceutical Industry Challenges Facing Clinical Trial Disclosure and Transparency By MMS Holdings and TrialAssure [Fill out the form below to access the whitepaper] While global regulatory authorities routinely update clinical trial disclosure and...
by Don McLean | Sep 12, 2019 | Blog
Planning for Health Canada’s New Transparency Initiatives for Clinical Data by Regina Parott In March 2019, Health Canada created a new transparency requirement. Health Canada’s Public Release of Clinical Information (PRCI) states that their “objective is to make...
by curtis@digitalliance.com | May 10, 2018 | Blog
Start plain language summaries early or get left behind by Staff writer In July 2019, the European Union (EU) Clinical Trial Regulation No. 536/2014 will go into effect, requiring all sponsors, including academia, conducting clinical trials to draft lay or plain...
by curtis@digitalliance.com | Jan 30, 2018 | Blog
FDA Furthers Transparency Push with CSR Release Pilot by Zach Weingarden, Guest Contributor The FDA provided insight into their overall vision for clinical trial transparency last week, announcing a new program to publicly release clinical study reports (CSRs) that...
by curtis@digitalliance.com | Jan 18, 2018 | Blog
Big Pharma: Big Improvements in Clinical Trial Transparency Compliance by Kasim McLain Bioethics International recently published their second, long-promised Good Pharma Scorecard, a ranking of large biopharmaceutical companies’ compliance with disclosing data for new...