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Blog
Closing the Loop: Part 5
The evolution of monitoring
Mary Jo Climie, Principal Compliance
Jul 02, 2020

In Part 4 of my 5-part series, I talked about the critical success factors of a compliance monitoring program and important questions to keep in mind. In this last part of the ‘Closing the Loop’ series, let’s discuss some other complimentary initiatives and how programs need to evolve to meet the complexities of the life sciences industry.

Complementary initiatives to compliance monitoring

One such initiative is a self-reporting protocol, where issues are identified to the compliance team at the time they occur, and action can be taken to document and correct the incident. In the case where compliance resources are stretched thin, you might also consider having the business monitor itself. This can be done by selecting samples and sending a simple questionnaire that can be completed by the activity owner and submitted to compliance for review and calibration. While it may take a bit of adjusting at first, this is a great way to bring an awareness of compliance to the business.

Another initiative is to perform adhoc interviews with internal stakeholders. This works best for larger engagements like advisory boards or complex engagements where vendors or other Third-Party Intermediaries (TPIs) have been used. You can interview both internal stakeholders and vendors used to execute the activity. The benefit with interviews is that you have an opportunity to get clarification and form a deeper understanding of the initiative. It’s also another opportunity to build relationships across the business.

Finally, there’s live monitoring through field work. This could come in the form of attending events and monitoring in real time or planning field ride-alongs. Both initiatives put you in the field which will give you a greater appreciation for the daily challenges of the business as well as help to build relationships. Ride-alongs provide compliance coaching opportunities through valuable one-on-one time to talk about compliance concerns or challenges. This can help:

  • Position yourself as a partner and not the police
  • Help keep compliance top of mind by putting a person to the role

The evolution of monitoring

I mentioned in my first blog in this series that the compliance ecosystem is ever-changing -- either through external or internal forces. There can be new legislation or government oversight activities that might force change within an organization. Or maybe, new or revised policies have been implemented at the global or regional level. Perhaps a new sales force was brought on board or a new vendor has been hired to manage HCP engagements and meetings. Any one of these factors can impact your monitoring program. Given this, what you put in place yesterday, may not be the right program for tomorrow. Monitoring is a dynamic system of checks, results, and continuous improvement. It must evolve with the organization and the external environment.

As you see more, you can do more – not necessarily in terms of outputs but in methodology or complementary monitoring activities like field work and live monitoring. Check in with leadership to make sure what you are delivering is still providing value and make the necessary changes to keep the business engaged. Doing this does not have to make the monitoring exercise bigger -- but it can make it better.

Compliance partners are agents of change

Lastly, I would like to close this blog series with the following thoughts.

Someone once said to me, in the compliance world, success is silent. It’s measured by the absence of problems. Because of this, it can easily be forgotten until there is an urgent need for intervention.

There is a misconception that compliance plays a passive supporting role in life science businesses, but I’d argue – and hopefully have proven in this blog series – that this should not be the case. By supporting the business through a cycle of program assessment and administration, controls and communication, and testing and reporting, a compliance monitoring program can help build relationships across an organization, bring value, and become an active partner in your business.

 

If you’ve enjoyed this blog series, I invite you to listen to our webinar, Resilience during trying times: How Compliance can work to plan, prepare and align for successful business outcomes, now available on-demand. In this webinar, you will hear Kirby James, an expert in strategic change management and building cultures of excellence, discuss how compliance professionals can facilitate change to support business resilience. This is a thought-provoking exploration of the role of compliance during times of crisis and how to drive strong performance and success during tough times.

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