How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
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Unfortunately, whether you've chosen the right clinical research organization (CRO) isn't always obvious until contracts are signed and patients are enrolled. In 2022, basic industry standard steps are being skipped left and right. Here are 6 win-win suggestions to incorporate into your vendor selection strategy/
About the Author
Penelope Przekop, CEO
MSQA, RQAP-GCP
Penelope Przekop is a is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial PV expertise. During the early 2000s, she developed and oversaw the first global PV quality and compliance departments established for Wyeth as well as Johson & Johnson. Her work includes qualification and oversight of numerous PV vendors covering all aspects of clinical safety and post-marketed PV. Penelope has facilitated numerous PV regulatory inspections. She frequently leads and conducts PV mock inspections and provides in-depth PV training.
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How Biopharma Leaders Can Ward Off A Perfect Storm: Part 2
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Learn more
Why Clinical Site Awareness Should Be "Day Zero" For SUSAR Reporting (1)
Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious adverse reaction (SUSAR), and you may get a variety of answers. While sponsors are ultimately responsible for SUSAR reporting adherence, Penelope Przekop contends that clinical sites should be the ones that start the clock when it comes to meeting regulatory timelines.
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Why Clinical Site Awareness Should Be "Day Zero" For SUSAR Reporting (1)
Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious adverse reaction (SUSAR), and you may get a variety of answers. While sponsors are ultimately responsible for SUSAR reporting adherence, Penelope Przekop contends that clinical sites should be the ones that start the clock when it comes to meeting regulatory timelines.
Learn more
3 Strategies To Lead Clinical Research With Moral Integrity
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
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3 Strategies To Lead Clinical Research With Moral Integrity
In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can we remain loyal to our shared code while also supporting the innovative solutions and approaches of the modern world?
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more
How Biopharma Leaders Can Ward Off A Perfect Storm: Part 1
Senior biopharma executives can strategically ward off this storm’s potential impact to our industry provided they are fully informed.
Learn more