| By Chuck Schaeffer
Using CRM, CMS & Social Networks to Manage Life Sciences Compliance
For many industries, regulatory compliance is something handled by a midlevel HR person in combination with other tasks such as planning the annual summer picnic. But for life sciences companies, transparency disclosure requirements such as the Sunshine Act make compliance in areas such as customer communications and clinical research mission critical, fluid and multifaceted. Compliance complexity is born from both varying regulations and statues by state, country and region as well as integrating compliance measures into a string of business processes that cross the life sciences companies and their third party business partners.
Life sciences companies are becoming less vertically integrated, and instead partnering and collaborating with interconnected business partners, affiliates and agencies for specialized services. Leveraging more specialists can clearly produce superior results, but can also create regulatory compliance challenges. For example, from copywriters to designers to brand teams to external marketing agencies to webmasters to field sales staff, with multiple approvers between every step, life sciences companies must be able to exercise content management with clear audit trails and traceability within their own companies and across connected business partners. Whether creating promotional materials or working with clinical research organizations (CROs), content is subject to specific regulations which mandate internal controls.
From my interactions with Life Sciences CEOs and executive teams it’s apparent that many pharma, biotech, cosmetic and medical device companies manage much of their regulatory compliance manually. Fortunately, there’s a better option.
Integrating CRM software with a Content Management System (CMS) facilitates automation and efficiency among customer facing business processes and the content that traverses those processes. Some business applications such as Microsoft Dynamics CRM and SharePoint offer an integrated and potent combination in managing and automating regulatory compliance for life sciences companies.
The Dynamics CRM software orchestrates key processes such as marketing and promotions, influencer and key opinion leader (KOL) outreach, field sales and account management, sample management and customer support. Each of these customer facing business processes is subject to sampling, aggregate spend and transparency disclosure requirements such as the Sunshine Act. Unlike most other vertical markets, the life sciences industry is under the microscope when it comes to approving and distributing customer communications, promotional materials and even sales messaging. To stay on the right side of these regulatory requirements, life science companies must manage production, approval, compliance and audit controls so that upon regulatory agency request or a filed complaint they can demonstrate every promotional material delivered to any client conforms to the process.
SharePoint is the de facto and most widely deployed CMS in the world. And within the life sciences industry, SharePoint can automate promotional materials management requirements including version control, online annotation (of text and rich media), content distribution history, 2253 form support, claims for ad reference support, support for the content lifecycle of distribution/ expiry/ withdraw/ periodic reviews and support for Medical, Legal and Regulatory (MLR) reviews.
SharePoint also brings sophisticated CMS capabilities such as granular security permissions, enterprise search, file/document status, approval processing, compliance & traceability, workflow automation, integration with Dynamics CRM and other business applications, and advanced reporting (such as audit trails and time-based reporting).
In fact as I've found multiple times over, SharePoint is an interesting tool in that it strikes a balance between ease of use and full enterprise CMS capabilities for life sciences companies, essentially spanning the entire life sciences regulatory life cycle, from R&D submissions to quality and manufacturing, medical communications, promotional materials management and clinical trials.
Another example which takes collaboration among partners to the next level is using an enterprise social network such as Yammer. Enterprise social networks are private (based on invitation) and generally segmented by group or topic. They also change the information flow and communication style from push-based to pull-based. Yammer participants can subscribe to the groups, topics or even individual collaterals which they want to receive and view updates in an activity stream. It’s a great method to be alerted when items you’re interested in incur change, and the resemblance to a Facebook or Twitter activity stream is yet another example of the consumerization of business IT.
Healthcare and life sciences companies incur unique regulatory controls concerning content and customer communications. And while content control and security must withstand regulatory oversight, creating a more holistic content management solution designed for clinical and business users, business processes and information reporting will deliver much greater adoption and payback. Easy access, easy administration and agility are hallmarks of an effective communication platform, and will most contribute to effective and efficient collaboration.
Certainly there are many options for automating content management and collaboration processes. But for companies which have invested in Microsoft technologies, or companies with the freedom to start with a blank slate, the out of the box integration among Dynamics CRM, SharePoint and Yammer offer life sciences companies a low cost and quick deployment option to grow their customer relationships while achieving compliance in an automated and efficient way.