Creating a Compliant Culture
By Ramon Chen, CMO, Reltio
This article was originally published in Pharma Compliance Monitor.
Creating a compliant culture: In this age of distributed data sources, commercialization of IT with “bring your own devices,” the demands of business to get faster and unrestricted access to data, compliance teams are more challenged than ever before. The reality is that although the onus of compliance and regulatory reporting fall to the select few within the enterprise that bear that title, being knowledgeable about best practices in handling sensitive data, and doing business in a compliant way is everyone’s responsibility.
Today’s modern data management platforms and technologies can track and audit the usage of data. History and lineage of changes by systems or individuals can be reconciled down to the field level. A new breed of business facing data-driven applications support collaboration, while maintaining compliance, and as a bonus, will help promote the right behaviors. Together they can help lower the cost of regulatory reporting, while preventing compliance issues before they occur.
Every life sciences organization has regulatory mandates that they must fulfill in order to avoid fines, and punitive levies that would restrict their ability to operate their business efficiently. Whether its Open Payments reporting, or Corporate Integrity Agreement (CIA) related activities that they must abide by, there are a set of required protocols, training and restrictions that must be enforced.
Those individuals most impacted on the commercial front are often the sales and marketing teams that deliver content, messaging and interact with the healthcare professionals (HCP) and healthcare organizations (HCO) to promote the company’s products. On the R&D side, careful handling of documents throughout the submissions process, clinical trial participants and activities, including an increasing focus on patient-centricity adds even more complexity.
Time to Move Beyond the Carrot and Stick
Making employees aware and tracking the delivery of compliant information includes mandatory training and certification courses. Generally delivered online through cloud-based learning management systems (LMS), these courses are required not just to ensure employees understand the gravity of compliance, but can be a regulatory pre-requisite in the enforcement of CIAs.
Unfortunately, most employees see compliance as a burden on their time. Chasing down individuals who need constant badgering to take training is an unpleasant and arduous task. The problems are compounded when the compliance and HR teams are not able to reliably determine who really needs to be taking the training in the first place. Another problem is handling exceptions; certain employees may be on medical leave or have dispensations. Additionally reconciling LMS courses with a fluid employee database is fraught with data synchronization issues and inaccuracies. Last year a top pharma company deployed a modern data management platformand data-driven apps to address this issue, and was able to reduce the number of employees who actually had to take training by 50%.
The message of “you must take this course … or else” is a stick with consequences that could range from poor annual reviews, to restricted access to sensitive data. Other companies have chosen to withhold compensation related to sales or performance bonuses, to ensure compliance. While these processes and methods have a level of effectiveness, it doesn’t engage the employee, nor change their perspective that compliance is a burden on their daily activities.
Morphing into a Compliant Culture
The evolution from “compliance-as-a-burden” to viewing compliance as a strategic fabric of a data-driven culture involves a seamless integration of compliant behaviors within the daily activities of each individual. If compliance is seen not as a time sink, but part of a process that will improve their operational effectiveness, thereby leading to greater success in their jobs, and their compensation, that’s a win-win.
Technology exists today to prevent compliance faux pas before they occur. It starts with a reliable data foundation to reconcile the profiles of customers and organizations that the company will interact with. Juxtaposed to this is the accurate, reliable management of content and messages that can be delivered to these entities, and the permissible, and preferred channels in which they will accept the information.
A modern data management platform checks all of these boxes, but it’s not enough. Business teams need easy to use interfaces that don’t require lengthy training. Their existing applications or a new suite of apps that are akin to Facebook or LinkedIn, should deliver relevant insights and recommended actions that prevent them from compliance violations. Letting data-driven apps help with the enforcement before issues occur, and making it’s a seamless part of activities can not only increase acceptance and prevent issues, but also significantly improve operational effectiveness.
Examples, in addition to the one described earlier around more efficient management of traditional LMS training for CIA governance, include understanding the customer’s profiles around specialties, licenses in real-time to avoid sample eligibility issues, or if they are qualified for certain events at seminars. Today qualifying an HCP to see if they can attend a seminar is not a real-time process, simply because the criteria required to evaluate such eligibility is siloed across multiple systems, and not available in real-time. Drop-ins to local events are certainly not supported, leading not only to missed opportunities, but customer dissatisfaction.
A further in depth review of the changing nature of technology and benefits was covered in detail in this article: “7 ways compliance will deliver operational efficiencies in 2016.”
Being Data-driven Includes Compliance
Rather than viewing compliance as a necessary evil, life sciences organizations have a transformational opportunity as part of a shift towards a data-driven culture. Being able to put in place technology such as modern data management to enable data-driven apps that improve the operational efficiencies of individuals includes freeing them of compliance burdens. This 2-for-1 is a significant competitive advantage that cannot be overlooked by any organization looking to achieve commercial and R&D excellence.