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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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.
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Amid all this financial and operational strategizing, a huge puzzle piece is often left to the side: compliance.
Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.
Despite recent progress in executing and documenting oversight, sponsor oversight remains a challenge, especially with monitoring reports. Penelope Przekop detail three reasons why they must remain top of mind.