by Prakash Achaary | Mar 31, 2022 | Blog
Plain language summary (PLS) writers take highly technical and scientific language and translate it into common language so that it can be understood by patients and caregivers with no formal training in science or medicine. Because a PLS needs to be comprehended by...
by Prakash Achaary | Jun 29, 2020 | Blog
By MMS Holdings and TrialAssure [Fill out the form below to access the whitepaper] While global regulatory authorities routinely update clinical trial disclosure and transparency requirements, new regulations set to take effect in 2020 and 2021 will dramatically...
by Prakash Achaary | Sep 12, 2019 | Blog
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 anonymized clinical information in drug submissions and medical device applications publicly...
by Prakash Achaary | May 10, 2018 | Blog
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 language summaries for phase 2-4 clinical trials. These lay summaries need to...
by Prakash Achaary | Jan 30, 2018 | Blog
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 accompany drug approval submissions. They plan to pilot nine recently-approved drugs (yet to...
