Site Selection and Start-Up

The success of a clinical trial is often dependent on the quality of sites selected for participation. Align CRO is able to properly identify, select, and begin study start-up processes within the trial timelines complying with the established Study Management Plan and Align CRO SOPs.

Align CRO is equipped to address site assessment, feasibility and selection in cooperation with the study sponsor in the following ways:

• Contacting potential sites through a database of Principal Investigators previously utilized for clinical trials or other sites identified in collaboration with the Sponsor

• Creating and disseminating feasibility questionnaires to potential sites for completion

• Evaluating the responses on the completed feasibility questionnaires to ensure only the appropriate sites are selected for on-site evaluation visits

• Creation and distribution of all required letters and documents regarding a site’s selection status.

• Performing site evaluation and site initiation visits utilizing Align CRO developed tools and SOPs

• Presenting all documented data from the site evaluation visit to the Sponsor before jointly deciding a site’s selection status

Align CRO employs a process of identifying and selecting the right sites to ensure a clinical trial’s success as efficiently as possible.