Your Easy Guide to Clinical Studies

Outsourced services are specific study tasks that have been delegated to study partners (e.g. Site-INV(s), laboratories, study monitoring). Partners must be qualified by education and training to perform these study services.

 

It is the responsibility of the SP-INV to:

• Select qualified partners
• Ensure services are based on quality standards. If applicable, request quality certificates (e.g. certified laboratories, ISO certified service providers)
• As applicable, ensure that services are performed according to the study protocol, required guidelines (e.g. GCP, ISO 14155, ISO 20916), and regulatory requirements (e.g. Swiss law)
• Perform regular checks in order to ensure ongoing compliance and quality of rendered services (e.g. perform an audit or monitoring isit at partner sites)

As a SP-INV, carefully select potential partners needed for the implementation of your study.

 

Based on yours study ask yourself:

• What kind of services need/can be outsourced?
• Does the hospital provide these services? Check availability of hospital internal service providers. These providers might already have relevant study experience, have shorter communication lines and can be more cost effective (e.g. local CTU)
• What is the cost-benefit ratio among providers? Hired services cost money. Remember to make appropriate budgetary adjustments.
• How can the quality of outsourced services be evaluated and guaranteed? Plan audits at partner institutions to verify the correct handling and operation of services, including material production and delivery.

 

References

ICH GCP E6(R2) – see in particular guideline

• 5.2 Contract Research Organization (CRO)

 

ISO 14155:2020 Medical devices (access liable to cost) - see in particular section

• 9.3 Outsourcing of duties and functions