Development↦Management↦Study Management↦Outsourced Services
What is it? Why is it important?
Outsourced services are specific study tasks that have been delegated to study partners (e.g. Site-INV(s), laboratory analysis, 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 provided based on quality standards. If applicable, request quality certificates (e.g. certified laboratories, Site-INV, GCP training)
- Ensure that services are performed according to the study protocol, GCP, and regulatory requirements
- Perform regular checks to ensure ongoing quality of rendered services, including ongoing compliance of all involved parties (e.g. the SP-INV can perform an audit or monitoring visit at partner site)
Quality checks can cover service providers:
Perform audits at partner institutions in order to verify the correct handling and operation of services, including material production and delivery.
- Prior to study start: Perform site-feasibility checks in order to evaluate whether a site fulfils SP-INV requirements for study participation.
- During study conduct: Perform regular monitoring visits at the site to ensure compliance with study protocol, GCP and regulatory requirements
What do I need to do?
Carefully select potential partners.
- What kind of services must be outsourced?
- Does the hospital provide applicable services?
- What is the cost benefit ratio among providers?
- How can the quality of services be evaluated and guaranteed?
Multi-centre studies does the site have:
- Qualified personnel?
- Sufficient eligible participants for the study?
- Disposable time for study investment?
- Required infrastructure?
Hired services cost money. Remember to make appropriate budgetary adjustments.
It might be an advantage to initially 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)
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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