SUMMARY

Module 2 

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 is an advanced course that provides you with solid knowledge of industry best practices for clinical outsourcing management. It will also make 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 to 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 your CRO and Vendors and increase the likelihood of good results.

This course builds on the learning of our basic course in Vendor Management and Oversight.

Keywords

• Clinical outsourcing management
• Clinical vendor management
• Vendor Oversight
• Risk Based Quality Management (RBQM)
• Investigator agreements