Essentials of Clinical Trials Outsourcing for Sponsors, CROs, and other Service Providers

Description of event:

Who will benefit from this training course:

Sponsors and CROs/service providers – contract managers, project managers and others involved in outsourcing clinical trials whether as the sponsor or service provider. This course is ideal for professionals at the early stages of their career in clinical outsourcing, vendor management, or proposal development. Whether you are a sponsor organisation, CRO, or service provider, you’ll gain essential knowledge and skills to confidently navigate this critical area of pharmaceutical and biotech operations.

Perfect for:

• Contract Managers and Project Managerslooking to build a strong foundation in clinical outsourcing and vendor relationships.
• Operational Stafftransitioning into roles involving oversight or collaboration with CROs and service providers.
• Business Development & Proposal Managersstarting out and eager to deepen their understanding of outsourcing dynamics.
• Procurement Professionals working with outsourcing of clinical trials

With its focus on the fundamentals, this course welcomes anyone new to clinical outsourcing, offering an engaging and supportive environment to develop your expertise and network with peers.

What does the training entail:

This comprehensive 2.5-day, in-person course provides a solid foundation in clinical outsourcing, covering all key topics essential to the field. Designed for full engagement, the program includes:

• Interactive breakout sessions with practical exercises.
• Ample networking opportunities to connect with peers and industry professionals.
• Q&A sessions to address participants’ objectives and specific challenges.
• Access to the expertise and insights of experienced trainers during presentations and informal discussions.

This immersive training ensures participants leave equipped with the knowledge, tools, and connections needed to excel in clinical outsourcing. All courses include a dynamic mix of practical exercises, plenary sessions, breakout discussions, surveys, and engaging video content to enhance learning and collaboration.

What will you get out of this:

After the training you will have a broad understanding of:

• The reasons for outsourcing
• The outsourcing process
• Your role therein
• Key elements of the contract
• Financial aspects in relation to outsourcing
• The position of the vendor
• How to measure performance
• The regulatory framework underpinning all of these

Throughout the networking sessions and exercises you will also get an understanding of other companies’ outsourcing practices.

 Topics Covered:

• The role of the Outsourcing Manager
  • Which tasks are included, what kind of skill set do you need and how can you be most effective?
• Strategies, suppliers and sourcing approaches
  • What are the key drivers for outsourcing and how do you create an outsourcing strategy?
  • What type of outsourcing models exist?
  • What type of outsourcing relationships exist and what makes an ideal vendor?
  • What does the vendor landscape look like?
• The Outsourcing process
  • What are the regulatory requirements and common inspection findings?
  • Which steps are involved in the process from request to contract and what happens thereafter?
• Contract models and legal issues
  • Which type of documents will you encounter?
  • What are the key elements and standard terms in a contract and what are the main challenges?
  • What type of contracts are there and how can you apply these?
• Financial considerations
  • What are bid grids and how do you interpret and compare them?
  • What type of costs are there and how are they calculated?
  • Which considerations are important for the payment schedule?
  • Why is it important to understand the vendor perspective?
• Oversight and performance & relationship management
  • What are the key requirements for study oversight with respect to outsourcing?
  • How do you conduct financial oversight?
  • Which tools are available to measure vendor performance?
  • What are the key elements of an effective relationship? 

What did previous trainees say:

• “Well-structured and insightful, the trainers provided a great theoretical overview accompanied by practical examples from their everyday work.”
• “Highly interesting, should be obliged for all new outsourcing managers.”
• “It was so useful to understand how CROs work and how to approach budget analysis and important factors to consider in the design of payment schedules.”
• “The course provided valuable knowledge to support my daily operation.”
• “Fantastic trainers! :-)”
• “Great course for any level! Lots of good tips and tricks and lots of exciting discussions throughout the course. Covers all general aspects of outsourcing.”
• “I had two great days getting a lot of inspiration and more knowledge of my role and outsourcing in general.”
• “Very good professionals with lots of experience.”
• “Even though there were three trainers, it was a good mix and communication between them. The course setup was well done, with interaction between trainers and time for collaboration.”
• “Excellent trainers, great and friendly attendees, fine environment – it’s been fantastic to be in London.”
• “Very informative and great value.”
• “Very good introduction to Outsourcing Management as a discipline – and what it includes.”
• “The real-life experience of the trainers really helped clarify the process.”
• “I learnt a lot from the perspective of the CRO, which was insightful.”
• “The event organizers were very, very good at engaging the attendees of the course.”

Booking Link: click here to book