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How Zero Contact GXP Audits Ensure Compliance While Protecting Auditors and Auditees during the Global Pandemic

How Zero Contact GXP Audits Ensure Compliance While Protecting Auditors and Auditees during the Global Pandemic

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,...
Part 4: The Case for Better Health History Records – Overcoming Barriers to Medical Records Access

Part 4: The Case for Better Health History Records – Overcoming Barriers to Medical Records Access

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...
Part 3: The Case for Better Health History Records – Identifying Barriers to Access

Part 3: The Case for Better Health History Records – Identifying Barriers to Access

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...
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?

Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?

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,...
Part 1: The Case for Better Health History Records – Regulatory Requirements

Part 1: The Case for Better Health History Records – Regulatory Requirements

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...

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