Clinical Monitoring

Overseeing the details of your clinical trial to ensure safe and successful clinical research projects

Clinical trial monitoring is a critical element in the safe, successful and timely conduct of a clinical trial. Proper monitoring ensures adherence to study protocol, as well as proper collection, processing and documentation of study data and events. Having an experienced clinical trial monitor to perform this necessary service is a significant advantage. By choosing ARI as your partner, you can be assured that you are working with some of the most experienced clinical trial monitors in the industry.

ARI’s clinical trial monitors have all been directly involved in the drug development industry for many years and have a strong knowledge of clinical research in a wide range of therapeutic areas. Understanding the mechanisms of diseases and the nuances of specific therapeutic conditions is a tremendous benefit, especially in very complex disease states.

At ARI, our clinical trial monitors receive ongoing training in a number of areas, including ICH-GCP and SAE reporting, CRF completion and therapeutic knowledge.

Our clinical trial monitoring team provides a wide array of services, including:

Preparation of monitoring plan, CRF completion guidelines and study related tools/forms
Investigative site qualification
Assistance in study start up activities
Participation in Investigator Meetings
Site initiation, routine monitoring visits and close outs visits
Adverse Event/Serious Adverse Event documentation and reporting
Study drug management
Study data query generation and resolution
Proactive identification of issues
Preparation of monitoring visit reports
Review and management of all study-related documentation
Primary contact for sites for routine communication and issues