Medical Affairs

When safety and study integrity is paramount, rest assured with ARI.

Protecting study participants’ safety and maintaining the protocol’s integrity is of paramount importance. Having the support of an experienced Medical Affairs and Medical Monitoring team is critical to ensure the safe and successful conduct of a clinical trial. ARI provides expert medical monitoring services through our highly experienced physicians, who have been involved in clinical research for twelve or more years. Selecting ARI to be your partner will give you the confidence of knowing that your trial and all the participants are under the care of the best in the industry.

ARI’s Medical Affairs team can assist with:

Assisting sponsors with protocol development from a scientific and medical perspective
Answering queries from investigators, study coordinators, clinical trial monitors and clinical project managers
Reviewing and responding to site initiated protocol waivers and deviations
Providing educational sessions at investigator meetings
Providing study-related training, as needed, to investigator site personnel
Addressing subject-specific issues on a case-by-case basis
Reviewing, clarifying (as needed) and assessing Serious Adverse Events (SAEs), and forwarding the SAE reports to the sponsor prior to submission to the FDA
Ensuring patients who experience SAEs are provided with proper, and if necessary ongoing, medical attention
Tracking the frequency and apparent causality of SAEs for subjects during a trial, so that appropriate action may be taken if needed to protect the subjects
Reviewing, and in many cases, assigning or clarifying codes for medical conditions, surgical procedures, and concomitant medications in collected patient data