Resources

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Podcast Episodes

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

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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.

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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.

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Critical to Quality Factor Identification Guide

Simplify CTQF identification and speed up risk-based quality management processes.

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Vendor Management and Oversight Assessment

Take the test, see how your current process measures up, see where you need improvement.

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10 Top Tips for vendor risk assessment

10 ways to immediately increase your vendor risk assessment capabilities.

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TMF Retrieval Guide for Sponsors

Use this guide and sure up your end of study TMF transfers from your CRO.

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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

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Vendor Risk Categories Cheat Sheet

Learn the difference between complimentary and unique risks of vendors, and how they apply to your vendor categories.

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Vendor Risk Management Checklist

Follow the list, check your process, conduct better vendor risk management.

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QMS Vendor Management SOP Checklist

A sample list of the required SOPs to ensure a robust procedural structure for vendor management.

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Vendor Communication Plan Template

Check the template, see how your current communication can be improved, or just implement it right away.