Duration: 90 Minutes


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How do you choose the right vendor? How is the onboarding and set up managed? How do you manage vendor performance, issues and ensure a smooth-running clinical study in compliance with current FDA regulations and ICH guidelines? Join this webinar to get answers to all these questions.

Why You Should Attend:

Vendor oversight is the responsibility of the sponsor company, but how can we accomplish this? Increased clinical research processes are being outsourcing by Sponsors. To accomplish this effectively both team and processes are needed in their places while bringing on vendors and managing them to be compliant and ensure a cohesive team approach.

This webinar by an industry expert – Pam Dellea-Giltner, will instruct participants on how to ensure the correct vendor for their organization and clinical study. The process starts with a cohesive team for the sponsor to define vendor specifications, internal and external planning, pre-selection, evaluating, negotiation, contracting and selection.

Free Materials:

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • Articles

Areas Covered in the Session :

The webinar will begin with a regulatory overview of sponsor responsibilities This will be followed by explanation on how to choose the right vendor. Finally, Best Practices for creating, implementing and maintaining tools to ensure the correct vendor is chosen for the sponsor requirements.

  • What do the Regulations mean?
  • Vendor oversight – Where do you start?
  • Vendor management as a team approach
  • Defining requirements
  • Quality insight and input
  • Pre-Qualification of a vendor
  • Use of Tools and Processes
  • Managing vendor performance

Who Should Attend:

  • Quality Departments
  • Regulatory Affairs Departments
  • IT Departments
  • CEO’s, CTO’s, VP’s and Contract VP’s
  • Contract Personnel
  • GxP Consultants


Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.

She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.

Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.