Auditing & Monitoring

We help clients assess the effectiveness of their compliance programs. Our experienced team of monitors are very comfortable conducting live monitoring and also analyzing data as part of retrospective audits. Our team provides you meaningful qualitative observations and quantitative metrics to help you identify and remediate compliance risks. What sets Potomac apart from the traditional auditor are our team’s experiences in the life sciences industry and knowledge of regulatory laws and guidelines.

The Potomac team can take on any of the auditing and monitoring tasks bogging down your compliance department, freeing up your time to focus on implementing risk mitigation initiatives instead of traveling across the country looking for observations. Our significant experience in the life sciences industry and knowledge of the regulatory environment allow us to quickly identify risks and propose remediation techniques often overlooked by compliance departments.

We help our clients build effective compliance programs by quickly identifying and communicating key observations and metrics.

What We Do

Risk Assessments
Risk assessments help prioritize compliance resources. We understand one size does not fill all and tailor our methodology and approach based on the need of the organization. This could include a high-level gap assessment of current compliance controls or a structured, quantitative-based bottom-up analysis of employee survey and interviews.
Planning and Protocol Development

We help compliance officers develop and formalize their auditing and monitoring programs by creating auditing & monitoring protocols, checklists, and databases to store and display monitoring results. Additionally, we work with our clients to refine their audit plan based on company-specific risk factors such as therapeutic area(s) and life cycle stage, geographies; prior monitoring results; or the perceived effectiveness of existing controls.

Live Monitoring

The Potomac team helps you succeed in ensuring your interactions with the medical community are appropriate. Our experienced monitors go into the field to assess interactions between HCPs and company personnel such as sales representatives, medical science liaisons, clinical nurse educators, and field reimbursement specialists.  We have the ability to quickly understand product-specific risks, commercial objectives, and the value of providing discrete feedback to the compliance organization.

In addition to ride-alongs, we also monitor events to assess adherence to company policies:

  • Speaker programs
  • Speaker training
  • Advisory boards
  • Conventions
Transactional Monitoring

Reviewing transactional documents can be extremely time consuming with low expected error rates.  Our team is adept at using technology to reduce burden.  Additionally, our team is experienced at knowing what to look for and can perform transactional monitoring at an affordable pricing for companies looking to outsource non-strategic tasks.  We audit documentation across a wide array of sources, including:

  • T&E entries
  • Speaker Programs
  • Third-party vendor expenses
  • Transparency data
  • Keyword monitoring (e.g., Call notes, field coaching, social media)
Dashboards and Data Analytics

The Potomac team leverages Tableau and back-end data systems to create custom dashboards, allowing you to visualize compliance metrics and quickly analyze trends in aggregated data. The process and end product are highly customizable and benefit both the Compliance and Commercial functions.

Further, Potomac River Partners houses experts with popular reporting systems such as Concur and Veeva. We are not afraid of large data sets or a unique challenge!

COntacts

Dan Koerner

Director

Dan has more than a decade of live monitoring experience, which includes more than 100 ride-alongs across multiple therapeutic areas: oncology, hematology, nephrology, psychiatry, urology, cardiology, neurology, addiction, and primary care.

Michael Young

Director

Michael is passionate about developing compliance dashboards that illuminate risk patterns and specializes in analyzing large datasets, including Sunshine reporting data and Concur transactions.

Graham Rich

Manager

Graham brings expertise on developing technology solutions to replace manual processes and works closely with our Consultants and Analysts to streamline operating processes for keyword and transactional monitoring teams.