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/
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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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?
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?
Part 1 of this article explained that the FDA's goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.
Part 1 of this article explained that the FDA's goal is to ensure safety not to provide a compliance safety net to sponsors by enabling arbitrary rules around SUSAR reporting timelines. A few readers raised points to justify using sponsor awareness as Day Zero for SUSAR reporting, regardless of when the PI becomes aware. Part 2 addresses those points and why they miss the mark.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.
The ultimate purpose of sponsor oversight is to act when required. Audits, meetings, and documentation are not always enough. Too many sponsors seem to be forgetting that they are the customer; one that’s paying a heavy price for services that can ultimately make or break them. Reset the industry balance with these 3 best practices.