Outsourcing Services

We are accountable for identify the activities to be outsourced and consider the requirements for outsourcing these activities to a Service Provider, such as:

• Applicable regulatory requirements

• The expected capacity, capability and experience of the ServiceProvider

• Company processes or systems that the Service Provider would folloor use

• Quality standards or performance requirements associated with the activities

• Use of a device or computerized system developed and maintained by the Service Provider for the collection of patient data.

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Additionaly:

- Determine any risks associated with outsourcing the activity. Consult
with Key Stakeholders, such as representatives from Safety,
Regulatory, Quality, if additional information is required.
- Liaise with the Sourcing Manager to share initial requirements defined
in activity

- Confirm the Sourcing Manager is aware of the anticipated start date of the Service Provider and that the activities to be outsourced are subject to GCP and/or GVP regulations.
- Obtain the Preferred Service Provider list from the Sourcing
Manager or the Category Manager, if it exists for that service.
Consider Service Providers on the Preferred Service Provider list
before other Service Providers.

- Inform the Requestor for Outsourcing Services of any critical issues
associated with Service Provider(s) on the Preferred Service Provider
list.

- If it is not possible to select a Preferred Service Provider, liaise with
the Sourcing Manager to determine if other Service Providers can be
considered New Service Providers can be considered once the Due
Diligence process is complete. Refer to Appendix 1 Due Diligence of
Service Providers.
- Review the information gathered for Service Providers under consideration and inform the Sourcing Manager of the Service Provider(s) to be sent a Request for Proposal (RFP).

- Confirm the Service Provider has identified all the staff that must
complete training prior to performing delegated activities and/or
gaining access to proper systems. The Service Provider is
responsible for maintaining documentation of their staff and
subcontractor (if needed) training, as well as ensuring any of their
new staff or subcontractors are trained on the process and/or
system.
- Liaise with the appropriate training representative and
coordinate the administration of required training.
-  Confirm all training has been completed and coordinate the provision
of system access to the Service Provider (if applicable).
- Inform the Service Provider if any processes or systems are updated
or revised, and coordinate any associated training.

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