by Don McLean | Jun 27, 2019 | Blog
Pharmaceutical Industry News Roundup: June 2019 by Staff writer Each month, MMS shares key stories on the evolution of the pharmaceutical industry. Here is a selection of top stories to keep an eye on: FDA ‘open for business’ in considering real-world evidence,...
by Don McLean | Apr 4, 2019 | Blog
Part 4: The Case for Better Health History Records – Overcoming Barriers to Medical Records Access by Barbara Rusin In Part 3 of this medical histories series, the focus centered on defining many of the barriers that clinical investigators face when attempting to...
by Don McLean | Mar 7, 2019 | Blog
Part 3: The Case for Better Health History Records – Identifying Barriers to Access by Barbara Rusin In Part 2 of this series, the focus was on ensuring adequate information to support subject eligibility. Knowing how many and what kinds of records to review is key to...
by Don McLean | Feb 21, 2019 | Blog
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed? by Barbara Rusin Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues...
by Don McLean | Aug 9, 2018 | Blog
Part 1: The Case for Better Health History Records – Regulatory Requirements by Barbara Rusin It is evident that during numerous audits, while working for the FDA and at MMS, clinical investigators are enrolling ineligible study subjects. A few of the ineligible...
