Ora's Support System

Ora’s staff includes dozens of clinical research associates (CRAs) that are highly trained to closely monitor every study that Ora runs.  Our professional, in-house staff of CRAs is dedicated to supporting each site’s success throughout the course of each trial.

Start Up

At start up, Ora’s Site Development Department will work with you to evaluate your site’s needs for each study.  We will then guide your site through the necessary regulatory process for active participation, including the completion of required regulatory documents, submission to an Institutional Review Board (IRB), and the development of a recruitment strategy that fulfills the needs of both the study and your site.  Prior to the start of the study, Ora will send a team of monitors and CRAs to your site to conduct the required qualification visit, as well as any additional upfront training.

Ongoing Study Coordination

During your site’s enrollment period, an Ora CRA will work closely with your study coordinator to ensure Good Clinical Practice (GCP) regulations are followed and that all Adverse Events (AEs) are tracked accordingly.  This Ora CRA will be available to answer questions at any point during the conduct of the study, and in many instances the CRA will also visit your site during the study to aid in ongoing coordination.

Study Completion/Close Out

Once enrollment has been completed for the study, Ora will assist your site by completing Data Clarification Forms (DCFs) generated by the respective data management groups, closing out the study with the IRB, and visiting the site one last time to ensure that the study is closed out correctly and completely.