Summary
This three-day course provides you with solid knowledge of best practices in clinical outsourcing, which you can apply to the processes surrounding the outsourced tasks.
You will learn about the ICH GCP E6 (R3) guideline and understand how to meet its requirements.
You will also learn about different contract and pricing models and gain insight into negotiation techniques.
We cover how to anticipate and handle potential challenges and how to resolve them.
By the end of the course, you will be better equipped to improve the relationship with your Contract Research Organisation (CRO) and vendors, helping you achieve better results.
Keywords
- Clinical outsourcing management
- Vendor qualification
- Performance monitoring
- Contracts
- Financial aspects
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Course leader & lecturers
- Tina HardeCourse leaderIndependent consultant
- - Laurynas DailideLecturerSr Category Lead
Novo Nordisk A/S - Thomas RichardsonLecturerSenior Clinical Outsourcing Compliance Manager
LEO Pharma A/S - Jacqui GatehouseLecturerFounder
GATEHOUSE THIRTEEN - Joy BladhLecturerFounder & CEO
Yoj ApS - Sue GregoryLecturerDirector, GCP QA
KLIFO A/S - Ulla SteenstrupLecturerSenior Director, Global R&D, Legal Lead
Genmab A/S
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Is this course for you?
This course is for employees in pharmaceutical, biotech or medical device companies whose responsibilities include collaboration with a clinical CRO. It is an advantage to have some experience in the field. You work as, for example, an Outsourcing Manager, Clinical Trial Manager, Clinical Project Manager or Project Nurse and want a competence boost and in-depth knowledge of best practices in clinical vendor management.
What you will learn
- The clinical and legal complexities of financial CRO contracts
- Best practice for the qualification of a clinical CRO
- How to negotiate with a CRO and mutually align expectations
- How to oversee and manage a CRO, including how to escalate and resolve issues
- Performance (KPI) and Quality (KQI) monitoring at vendor level
- ICH GCP (E6) R3 in relation to sponsors, CROs and suppliers
What your company will get
- An employee who understands the general principles of the legal part of a CRO agreement.
- An employee familiar with the outsourcing process, who can choose the right CRO for a study.
- An employee who can coordinate the scope of outsourced activities, use effective negotiation techniques and choose the best budget and payment structure.
- An employee who can follow up on deliveries with high quality in supervision and risk management.
Course calendar
Day 1
- What is vendor management and which operation models exist?
- What is fully outsourcing versus functional service provider?
- Contracts
- CRO Performance Management
Day 2
- Contracts - GDPR
- Qualification of vendors
- Start-up phase
- Governance
- Collaboration and building relationship between Pharma and CRO/Supplier
Day 3
- Maintenance Phase and vendor oversight
- Closure phase and lessons learnt
- Financial Considerations and understanding required by a Vendor Manager
- Negotiation
Registration
Registration deadline21 Sep 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course, you get access to mandatory and/or optional readings via your personal Atrium log-in.
Examination
There is no examination for this course.
Course leader
-
Lecturers
Novo Nordisk A/S
LEO Pharma A/S
GATEHOUSE THIRTEEN
Yoj ApS
KLIFO A/S
Genmab A/S
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8 Dec 2026
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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