The primary responsibility of pharmaceutical compliance professionals is to ensure their organizations adhere to government requirements and all company activities align with regulatory policies. An important element of an effective Field Based Monitoring Program includes a reliable plan for compliance reporting.

This newsletter will outline five (5) key considerations to enhance reporting of field based monitoring and improve the impact of compliance efforts.

1.  Identify the Right Key Performance Indicators (KPIs)

Key Performance Indicators (“KPIs”) are a set of quantifiable measures that a company or specific industry uses to gauge and/or compare performance when meeting strategic and operational goals. In order to provide reports that are relevant and valued by stakeholders, KPIs must first be identified and measured. As it relates to compliance, there are at least three types of KPIs:

  1. Behavioral metrics: “What are we doing to improve our compliance performance?”
  2. Process metrics: “How reliable are our compliance management systems?”
  3. Outcome metrics: “Are our activities and systems yielding improved compliance outcomes?”

Jim Nortz, Chief Compliance Officer for Carestream Health, offers the following tips for establishing KPIs to measure compliance:

  • Select and use the metrics your organization needs to make sound decisions and/or drive behavior
  • Use simple dashboards that are  easy to understand
  • Correlate process and activities metrics with related outcome metrics
  • Gather data that will help you identify whether or not there is a cause and effect relationship between your compliance and ethics program and key outcomes
  • Use metrics not only to measure behavior, but also to drive it – encourage your management team to set performance targets that hold directors, officers, and employees accountable for achieving them
  • Calibrate expectations – ensure management understands the challenges of creating a culture of compliance and help them to consider these challenges when aligning on KPIs and setting compliance goals

2. Identify Key Stakeholders and What’s Important to each of Them

Designing parameters for effective compliance reporting requires understanding the needs and expectations of the internal and external stakeholders. The compliance reporting expectations of internal stakeholders in Sales Leadership, HR, Legal, and external stakeholders in the Office of the Inspector General may be very different.   Compliance officials should:

  • Proactively engage internal and external stakeholders to identify what evidence they expect to see
  • Determine what measures would best demonstrate that appropriate behaviors have been observed
  • Identify what processes currently exist to promote and maintain compliant behavior
  • Tailor reports to different stakeholder needs and provide insights that are relevant to each stakeholder group

3.  Align on Report Frequency, Format, and Delivery Methods

A compliance report that does not get read cannot provide value. To ensure compliance reports receive the desired attention, it is important to:

  • Ensure all stakeholders understand the format of the reports, how they will be delivered, and when they should expect to be received
  • Establish a report frequency that allows you to share worthwhile insights and performance trends
  • Ensure compliance KPIs are clearly visible in all reports
  • Create a format that is user friendly

Stakeholders should not be expected to comb through piles of data in order to review key findings. Ensure compliance KPIs are clearly visible in all reports.

Leveraging information delivery methods (i.e., email, posted online, printed publication) most appropriate to each stakeholder should be a standard practice. This will ensure that compliance reports get into the hands of the intended targets.

4.  Publicize Significant Data Points (Trends and Outliers)

Compliance reporting on Field Based Monitoring activity should demonstrate that improved compliance outcomes are being achieved. Reports should be used to:

  • Point out significant trends
  • Highlight performance in key risk areas
  • Validate the impact of compliance training efforts
  • Identify areas of concern

5.  Consolidate and Coordinate Data Sources

In most pharmaceutical companies, there is no shortage of data available. More often, the challenge is in analyzing the right sources of data and in properly interpreting them to gain actionable insights. When reporting on field based monitoring activity, it is essential to ensure that the data sources used are reliable and robust, and that they provide accurate measures of compliance behavior.

Please feel free to use the recommendations and considerations to improve your compliance reports. The result will be an enhanced Field Based Monitoring process that will be valued by your stakeholders and will inform your future compliance practices.

Wendy L. Heckelman, Ph.D.

Dr. Wendy Heckelman, president and founder of WLH Consulting, Inc. has over 30 years of experience working with Fortune 100 industry clients. These include pharmaceutical, biotech, health care, animal health medicines, and consumer products, as well as international non-profit organizations and growing entrepreneurial companies.

Field Force MonitoringComplianceNewsletters