Resources
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Podcast Episodes
Trial Oversight Spotlight #7: Henrieke de Bie
In this episode, Tom interviews Henrieke de Bie, Founder of Beyond Compliance.
Trial Oversight Spotlight #6: Keith Berelowitz
In this episode, Tom interviews Keith Berelowitz, Founder of PatientRx.
Trial Oversight Spotlight #5: Christoph Ortland
In this episode, Tom interviews Christoph Ortland, Founder and CEO of FD CRO.
Trial Oversight Spotlight #4: Yvanne Enever
In this episode, Tom interviews Yvanne Enever, Founder and CEO of PHARMExcel.
Trial Oversight Spotlight #3: Virginie Barthel
In this episode, Tom sits down with Virginie Barthel, Clinical Operations Consultant.
Trial Oversight Spotlight #2: Jo Burmester
In this episode Tom sits down with Jo Burmester, a GCP Trainer and consultant.
Trial Oversight Spotlight #1: Smaranda Doucet
In this episode Tom sits down with Smaranda Doucet, Founder, FlowTrial.
Papers and Guides
Research Paper: Key Challenges of Clinical Trial Vendor Management
Qualitative Analysis and Conclusions from survey research generated from peers in Clinical Operations, Quality, Executives and Ex-inspectors.
White Paper: Why Vendor Management and Oversight Matter More Than You Think
A deep dive into the challenges and best practices of components for clinical trial vendor management, from Selection to KPIs and more.
Critical to Quality Factor Identification Guide
Simplify CTQF identification and speed up risk-based quality management processes.
Vendor Management and Oversight Assessment
Take the test, see how your current process measures up, see where you need improvement.
10 Top Tips for vendor risk assessment
10 ways to immediately increase your vendor risk assessment capabilities.
TMF Retrieval Guide for Sponsors
Use this guide and sure up your end of study TMF transfers from your CRO.
Vendor Management and Oversight - Analogies, Context and Discussion
Tom talks about Vendor Management and what we can learn from the Sydney Opera House.
Tools and Templates
Vendor Risk Categories Cheat Sheet
Learn the difference between complimentary and unique risks of vendors, and how they apply to your vendor categories.
Vendor Risk Management Checklist
Follow the list, check your process, conduct better vendor risk management.
QMS Vendor Management SOP Checklist
A sample list of the required SOPs to ensure a robust procedural structure for vendor management.
Vendor Communication Plan Template
Check the template, see how your current communication can be improved, or just implement it right away.