3 Reasons Why Sponsors Must Review Monitoring Reports

December 5, 2023
By Penelope Przekop
Clinical
Investigator Site Monitoring
Clinical Research
Sponsor Oversight
Inspection Readiness

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.

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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