by Avery Zimmerman | Aug 27, 2020 | Blog
Remote audits are crucial for auditors and auditees in the pharmaceutical industry to help reduce health risks since the advent of the COVID-19 global pandemic. On-site inspections across pharma and other industries may not be possible due to multiple factors,...
by Avery Zimmerman | Apr 4, 2019 | Blog
In Part 3 of this medical histories series, the focus centered on defining many of the barriers that clinical investigators face when attempting to procure adequate medical records for subject eligibility determination. While the list of potential issues appeared...
by Avery Zimmerman | Mar 7, 2019 | Blog
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 developing a robust review program to ensure subject eligibility, as is knowing how to reconcile...
by Avery Zimmerman | Feb 21, 2019 | Blog
Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues which can arise when ineligible subjects are enrolled. As noted, the outcomes vary depending on whether you are a clinical site,...
by Avery Zimmerman | Aug 9, 2018 | Blog
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 subjects receive waivers before enrollment, however many do not. Ineligibility is often not clear...
