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Whitepaper: Six Changes that Pharmaceutical Companies Should Consider in Response to COVID-19

Whitepaper: Six Changes that Pharmaceutical Companies Should Consider in Response to COVID-19

by Avery Zimmerman | Apr 8, 2020 | Blog

[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 across the globe have rushed to implement countermeasures and develop best practices to curtail...
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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