by Don McLean | Apr 8, 2020 | Blog
Whitepaper: Six Changes that Pharmaceutical Companies Should Consider in Response to COVID-19 [Fill out the form below to access the whitepaper] In the wake of the global pandemic of COVID-19, also known and SARS-COV-2, regulators, health authorities, and lawmakers...
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...
