Auditing & Monitoring

We offer a range of services to help clients assess the effectiveness of their compliance programs.

Risk Assessments. We perform thorough risk assessments to help identify where to prioritize your activities. This can include conducting a gap assessment of compliance controls and providing specific recommendations on how to mitigate risk. Additionally, we can evaluate product specific factors such as therapeutic area or product life cycle stage, geographic reach, and existing controls, to help refine your audit plan.

Planning.  We help compliance departments setup their auditing or monitoring program. We provide training on effective auditing techniques and how to launch live monitoring campaigns. This includes detailed monitoring protocols, checklists, guides and other audit tools.

Sample Audit Scope

Sample Audit Scope

Monitoring Tools

Live Monitoring. Our experienced monitors have conducted ride-alongs with sales representatives, Medical Science Liaisons, field reimbursement, and Nurse Educators, and attended advisory boards, speaker training, exhibits and numerous speaker programs.

For information on our recommendation on how to structure a live monitoring program, click here to view an article that we published in Rx Compliance Report.

Retrospective Reviews. We also conduct traditional documentation audits, including:

    • T&E entries
    • Call notes
    • Speaker Programs, grants and other events
    • Third-party vendor expenses
    • Aggregate spend data
    • Social media

These record reviews assess whether data is accurate and help to ensure your compliance policies, procedures, and training have been implemented appropriately.

Dashboards and Data Analytics. Using Tableau, we create custom dashboards to track aggregate data and perform analyses which provide real-time insights that benefit both the Compliance and Commercial functions.

Click here to access our Auditing & Monitoring brochure.