A range of contract research organizations (CROs) offer specialized phase 1 trial services. It may therefore be more efficient to outsource the conduct of a trial to a CRO. However, overall responsibility for a trial remains with the sponsor/sponsoring organization.

Typically, selection of a CRO is based on the following process:

  • Identify suitably qualified CROs based on their experience of relevant studies (here phase 1 FIH) and the services required. Clinical trial responsibilities include: regulatory affairs, site selection and management, monitoring, data management, drug safety, biostatistics, medical writing, and project management.
  • Establish a confidential disclosure agreement (CDA) with the CROs and prepare a “request for proposals” (RFP). An RFP includes detailed specifications for the processes and tasks to be outsourced, expectations for the performance of duties, and trial timeline.
  • Review the proposals and arrange for a capabilities presentation by the CROs, where they outline their experience with trials, ability to meet quality and technical requirements, infrastructure and staffing, and proposed processes to achieve set timelines.
  • On the basis of the information received and proposed costs, select a CRO and phase 1 site. Selection criteria are likely to include experience in conduct of FIH studies, access to subjects, quality management systems, regulatory inspection history, responsiveness, financial stability, and cost.
    • An audit by a quality assurance expert should be conducted to ensure that all regulatory and quality expectations are met.
  • With legal input, establish a contract with the CRO. A contract should specify all critical elements of the relationship between sponsor and CRO, including project assumptions, delegation of responsibilities, timelines and budget

A sponsor’s clinical team should collaborate with the CRO and phase I unit to complete the activities outlined in ICH E6 (R2) guidance.

Figure: Development of a study design and appointment of a CRO [internal note: figure to be redesigned if considered valuable by the reviewers]