A Risk-Based Approach to Vendor Qualification and Management

A Practical Guide for Clinical Trial Sponsors

This webinar was held on Tuesday July 11th, 2023

When outsourcing services or technologies in support of clinical trials, the most efficient use of resources and time available is to use a risk-based approach for the qualification of service providers.

However, for many clinical trial sponsor companies, developing an effective risk-based approach to service provider qualification can feel overwhelming and fraught with potential regulatory compliance / inspection risks, timeline delays and complex vendor selection decisions.

The solution is to adopt an enterprise framework and approach that incorporates risk-based attributes for service provider pre-qualification, performance oversight and audit. This comprehensive approach can be scaled and applied to all phases of clinical research, all capabilities / technologies to be assessed, and all geographies for your trial.

This webinar shares practical advice from experts with experience from within trial sponsors on how to implement such an enterprise framework, and will cover the information resources available to cut the work required.

All our speakers currently work with a clinical trial sponsor and/or have 25+ years of outsourcing experience within trial sponsors.

Who should view the webinar:

This webinar will benefit VPs, Directors and Managers in clinical trial sponsors and CROs responsible for:

  • Quality Assurance

  • Clinical Operations

  • Vendor/Outsourcing Management

  • Compliance/Regulatory Management

  • Directors/Heads of Innovation

It will also hold useful insights for Contracts, QA and Compliance staff at clinical trial service providers!

The risks of ineffective qualification of service or technology providers for clinical trials

What an effective enterprise framework of risk-based attributes looks like

Practical advice on how to implement such a framework in your organization

An explanation of the information and tools available from Diligent

Hear honest advice and put your questions to our panel of clinical research quality experts

Jennifer Sessions

VP, Client Services, Diligent Pharma

Jennifer has over 25 years of experience in clinical research with Eli Lilly & Co, academia and biotechnology sectors. Most recently, she served as the CEO of Cynvec, a private biotech company focused on cancer therapies.

Cristin MacDonald

Krista Kerr 

Sr. Director, Global Quality Management, Cerevel Therapeutics

Krista is Senior Director of Global Quality Management at Cerevel Therapeutics. Krista has spent nearly 30 years in pharmaceutical development quality, with tenure at both large and small pharma companies. Krista brings multidisciplinary expertise across multiple GxP areas and is committed to seeking modern, risk-based approaches to quality management.

Chris Otto

Chris Otto

Senior Advisor / Consultant Diligent Pharma

Chris brings almost 30 years of pharmaceutical industry experience, mainly at Eli Lilly & Co. His experiences include functional leadership roles in Clinical Laboratory Sciences, Clinical Data Sciences, eCOA/ePRO/Connected Devices/Digital Health, Clinical imaging, Decentralized Clinical Trials, Clinical Pharmacology and R&D Information Technology. Chris has led organizations in the UK, Germany, Spain, Singapore, Japan and China.

Jay Turpen

Jay Turpen

Head of Quality, Diligent Pharma

Jay leads a team of staff and Auditors that implement a risk-based qualification service for clients of Diligent Pharma. He has been in the pharmaceutical industry for 32 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new drug candidates.

Put your questions to our expert panel!

Ask our speakers for their comments on any specific questions –
Simply email

Choose your adventure in decentralized clinical trials

A Risk-Based Approach to Vendor Qualification and Management 

A Practical Guide for Clinical Trial Sponsors