MODULE 2
SUMMARY
Are you compliant with the ICH GCP E6 Guideline R2 revisions on sponsors, Sites, Contract Research Organisations (CROs) and Vendors? And are you confident in your interaction and negotiation with these?
This Diploma course consists of two modules that together provide you with solid knowledge of best industry practices for clinical outsourcing management as well as ensures that you feel confident performing high-quality Oversight of your selected Vendors, your CRO and its subcontractors.
It also provides you with a thorough knowledge about how you comply with ICH GCP E6 Guideline R2. You also gain confidence in ensuring Oversight of any trial-related duties and functions carried out on your behalf, including those that are subcontracted to another party by the sponsor’s contracted CRO(s) and Vendor(s).
Among other things, you learn about negotiation techniques, different contractual and pricing models with CROs as well as how to foresee potentials misunderstandings and issues and how to resolve these.
All in all, this will enable you to improve relations with CRO and Vendors and increase the possibility of better results.
KEY WORDS
- Clinical Outsourcing Management
- Clinical Vendor Management
- Vendor Oversight
- Conflict Management
- Clinical Trials
- Risk Management
- Risk Based Quality Management (RBQM)
- Negotiation Techniques
- Financial Negotiation
- Legal Contracts
- Corporate Social Responsibility (CSR)
- HCP Transparency
- Compliance
- Vendor Governance
- Investigator Agreements
Hi!
Do you need help choosing the right course?
We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com
IS THIS COURSE FOR YOU?
This Diploma course is solely for employees in pharmaceutical, biotech and medical device companies, whose responsibilities include interacting with a CRO. You have at least 1 year’s experience as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and are looking for a more in-depth understanding of best practices and a competence boost in clinical outsourcing.
What you will learn
Industry best practices for how to:
- Plan, qualify and select a CRO for a clinical study
- Negotiate and align expectations with a CRO
- Better understand the financial and legal complexities of CRO and Site Agreements
- How to perform CRO Oversight
- How to manage a CRO, e.g. how to escalate and resolve issues
- Understand ICH GCP E6 guideline R2 revisions on sponsors, Sites, CROs and Vendors
What your company will get
An employee who feels confident in:
- The outsourcing process including how to select the right CRO for a study
- Aligning expectations and scoping the outsourced activities correctly
- Following up on CRO deliverables, including how to perform high quality Oversight and risk management
- Understanding and using the best negotiation technique as well as the best financial set-up and payment structure
- Resolving issues and conflicts with CROs
- The contents of the legal contract with CRO and Site
Course information
Literature
Prior to the course you get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarise yourself with the mandatory readings before starting the course; it is also part of the curriculum for examination.
Prerequisites
This Diploma course is solely for employees in pharmaceutical, biotech and medical device companies, whose responsibilities include interacting with a CRO. You have at least 1 year’s experience as e.g. Outsourcing Manager, Clinical Trial Manager, or Clinical Project Manager and are looking for a more in-depth understanding of best practices and a competence boost in clinical outsourcing.
To participate in this module 2, we recommend prior participation in Diploma in vendor mangement and oversight – modul 1 in order to understand the concepts and procedures covered. Alternatively, you have similar skills as those obtained on Module 1 from other education or experience
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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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