Clinical Outsourcing: Vendor Management and Oversight

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Course Overview


To ensure patient safety and effectiveness, clinical trials are conducted to extremely high standards and must follow regulatory compliance. Sponsor organisations require robust structures for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials. If not correctly done, pharma companies run the risk of receiving warning letters from competent authorities.


This vendor management and oversight training course will focus on the responsibilities of a sponsor. You will learn several strategies to ensure effective management of your trials and relationships with your vendors. It will also ensure you are fully aware of the regulatory and quality expectations you must comply with as a sponsor. Once completed, you will have the skill confidence to manage your clinical trial vendors.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver classroom and live online training.

Key Learning Objectives


  • Ensure you understand the regulatory expectations including the ICH proposed revisions
  • Look at the different approaches to vendor management and oversight, determining the critical success factors and when to use each strategy
  • Understand how to implement a governance structure aligned to your organisations outsourcing policy
  • Performance Management with Technology and clinical vendors
  • Discuss what quality metrics to implement and best practices for monitoring them
  • Learn how to implement time and cost saving project management strategies
What is included in a live online course?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file

Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)

Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges
Introductory Module 1

60 mins

Vendor oversight and management overview

  • Introduction to vendor oversight
  • Why is it important?
Module 2

 120 mins

Meeting regulatory expectations when outsourcing

  • Examining EU and US regulatory expectations and requirements, ICH proposed revisions
  • Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
  • MHRA GCP Guidelines
  • Understanding transfer of obligations rather than transfer of responsibilities
  • Case studies: Example where the sponsor/CRO has failed to comply with regulation / received warning letters
  • How can sponsors ensure meeting regulatory expectations?
  • Inspections
  • Activity: Inspection readiness with vendors
Module 3

120 mins

Vendor management: What are the key components of vendor management?

  • Outsourcing models
  • What are the Key components of vendor Management?
  • RACI
  • Ensuring and enabling operational deliverables
  • Monitoring and documentation of goals, deliverables and quality
  • Achieving effective management across multiple service providers
  • Activity: Design your ideal outsourcing model to include vendor management


Module 4

120 mins

What are the key components of vendor oversight?

  • What is difference between vendor management and vendor oversight?
  • What is defined as success for vendor oversight?
  • Define your oversight philosophy
  • Demonstrating control to inspectors
  • Effective shared risk approaches to vendor oversight: ‘Skin in the game’
  • Hands on/hands off – does it matter?
  • Auditing strategy: Reaffirmation of vendor capabilities and CAPA management
  • Activity: Outsourcing Oversight is easy


Module 5

120 mins

Risk management in clinical outsourcing

  • Risk Management for Outsourcing
  • Risk Identification
  • Risk Impact Mitigation through Risk Management
  • Risk Management Plan
  • Activity: Risk identification

Issue management

  • Who is responsible for issue management?
  • Root Cause analysis
  • Is there a clear escalation pathway?
  • Tracing of issues to use for trending
  • Activity: Root cause analysis


Module 6

120 mins

What is governance? implementing an effective governance structure for your models to drive all outcomes

  • Ensuring organizational alignment to outsourcing strategy
  • What is required for effective governance of vendors?
  • Delegation through escalation
  • Activity: Driving performance
  • Using metrics effectively when outsourcing
  • Why do you measure?
  • What do you measure?
  • Metrics to measure your performance
  • Metrics to measure vendor’s performance
  • Metrics to drive transparency
  • Metrics to drive trust
  • Metrics for quality management
  • Activity:  We all love metrics
Module 7

120 mins

Maintaining healthy business relationships

  • What Makes a Successful Business Relationship?
  • Understanding Different Communication Styles
  • Recognise that individuals have different communication styles including positive and negative body language, verbal tomes and eye contact
  • Recognise how through excellent self-management you can build excellent business relationships
  • Remember that listening and observing skills are critical to developing robust business relationships
  • Activity: Observe


  • Benefits and Risks when Off-Shoring
  • Where to Off-shore?
  • Challenges
  • Culture
  • Activity: Will off-shoring work for you?
Module 8

120 mins

Improvements in management, oversight and governance you should implement

  • Review 3 weeks post of the previous module

Julianne Hull – With 30+ years of global leadership experience within the pharmaceutical industry, Julianne has broad and in-depth knowledge of how Clinical Trials work. Having been a global leader for operations planning and vendor management within Wyeth she established and led the fora to ensure collaborative cross-functional delivery of all phase 1 to 3 clinical studies. Julianne has worked in the large, medium, and small pharma providing valuable perspectives on the varying constraints and enablers to project delivery.


Julianne delivers training programmes globally on several different clinical topics bringing her real-life experiences to the classroom. Julianne has an easy and interactive style which ensures the class engage and take the most from the training.

All professionals who are involved in clinical trials will benefit from this course, especially those involved in vendor management and oversight, including: Clinical Operations | Clinical Outsourcing | Vendor Management | Clinical Quality Assurance/Control | Global QA | Compliance | Regulatory Affairs

Free Online Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

Frequently asked questions (FAQs)

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.


For more information you can email us at [email protected] or call +44 (0) 203 111 7357.


Complete our contact form by following the link. Get in touch.


• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.