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Trial Regulatory Document Management: Balance Through Best Practice

Available Until: November 15, 2012

Complimentary Webinar Sponsored by: Clinical Financial Services

This session is to review Clinical Site Regulatory Document Management Best Practices from the CRO or Sponsor perspective. The presentation will include how to establish a Quality Management System for the investigator regdoc process that meets FDA regulations and ICH GCP guidelines as well as sponsor study requirements in an efficient manner.  A few of the highlighted topics are:

  • Collection vs. QC Review
  • RegDoc Tools & Review Training
  • Communications
  • File Maintenance

 


 

Speaker

Patrice H. Pompa, Director Site Activation Services, CFS

Ms. Pompa recently joined Clinical Financial Services as Director of Site Activation Services and is responsible for the collection, review, processing and tracking of investigator site essential regulatory documents required to activate investigator sites. Prior to joining CFS, Ms. Pompa spent 25+ years at SmithKline Beecham/GlaxoSmithKline in several long-term leadership positions in R&D Clinical Operations and Medical Affairs.  Most recently, she was the Senior Director head of Oncology Study Management, and earlier, Cardiovascular/Urology Study Management.  She was also Sr. Director of Clinical Monitoring North America for 19 years. She has created and organized multiple operational departments, managed both in-house and field-based staff, and led global initiatives which embedded the use of eClinical trial electronic data capture tools within study management.  Prior to GSK, Ms. Pompa held clinical research positions at Stuart Pharmaceuticals (now Astra-Zeneca), McNeil Laboratories, and Pennsylvania Hospital OB/GYN Research.

Ms. Pompa has a B.A. in Psychology/ Biology from Swarthmore College in Swarthmore, PA.