Regulatory compliance data: the opportunity for greater KOL engagement

compliance_technologyHow can data compliance requirements be transformed into strategic opportunities, and how is Medical Affairs central to all this? In a recent webinar, Harleen Parmar, Senior Product Marketing Manager here at Zephyr Health, debated this topic with Seth Whitelaw, President & CEO of Whitelaw Compliance Group LLC and Blake Morrison, Founder of venn5 Bioconsulting LLC. With more than 50 years of combined industry experience between the panel members, we share below some of the key discussion points and conclusions.

Medical Affairs – crucial to compliance, essential to engagement

The role of Medical Affairs has grown in stature and influence both within pharmaceutical companies and throughout the wider healthcare landscape in recent years. If we put the educational aspect of the role to one side, from a compliance standpoint, the Medical Affairs fulfills three critical tasks:

  1. Ensuring data included in promotional materials is fair and balanced, complete and accurate
  2. Ensuring that any off-label materials are provided expressly in response to unsolicited requests and are not considered misleading
  3. Ensuring that healthcare professionals (HCPs) engaged by the company have the appropriate qualifications

The third point is not always as simple as it sounds. One of the biggest challenges is determining who could be what we would call a ‘bad apple’. Who are the HCPs that you do not want to do business with?

Qualifying Key Opinion Leaders (KOLs)

So how does a pharmaceutical company determine which HCPs to engage with? Historically, the task has been manual, using online search engines and personal opinion, and the decision highly subjective. The result is fragmented datasets that are at the mercy of the speed and accuracy of the updates.

There is a vast amount of data available that can be mined and used to help define the KOL criteria, including: accreditation, funding sources, affiliations, clinical trials involvements/recommendations, experience, editorial and medical journal activities, to name but a few. Processing this information manually is not just time consuming, it leaves too much room for error and too many opportunities for compliance missteps.

Next-generation technology solutions can solve these challenges. Data management and analytics platforms today provide a complete, consistent, and objective view of the customer. Data is regularly and automatically refreshed, saving time previously spent manually searching for updates. Such technology can allow Medical Affairs teams to run a customer query in less than two minutes where previously that data was being manually scraped, often taking days – or in some cases – weeks.

The commercial opportunities of compliance

Given that almost half of prescribers have a ‘no see’ policy for sales reps today, it is unsurprising that there is increasing focus on Medical Affairs who still regularly engage with clinicians. With a sound strategy and data management platform, new opportunities for pharmaceutical companies are emerging:

  1. Thought leader identification and management: By automating the data scraping process, centralizing information and applying data analytics, KOL identification becomes far more reliable, accurate and timely.
  2. Aligning home office and field: For Medical Affairs engaging with physicians outside the office, a challenge is typically identifying changes in their profiles with data being stored in several locations, often remotely. Today’s next generation data management technology breaks down these silos, ensuring both compliance and commercial accuracy across home office and field.
  3. Medical Affairs activity measurement: Given the restrictions on linking Medical Affairs activities to sales and revenue, demonstrating the value they provide is a challenge. By employing an intelligent data strategy and a reliable platform, companies can accurately measure activity levels while cross-referencing them with KOL engagement and overall progress.

The need for compliance and transparency is increasing. As more countries begin to adopt ‘Sunshine Act’ equivalents and other transparency measures, data management at scale will become vital to avoiding regulatory errors. However, this push towards transparency encourages better data management and intelligent uses of that information that provides new and unexpected opportunities for a greater understanding of, and engagement with KOLs and other stakeholders within healthcare.

To download the SlideShare, please visit:

To view the webinar on demand, please visit:

To download the white paper, please visit: