The Easiest Life Sciences Regulatory Compliance Solutions

Simple But Effective Life Sciences Regulatory Compliance

For many industries, regulatory compliance is something handled by a midlevel manager in combination with other tasks. 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.

Life sciences regulatory compliance complexity is born from varying regulations and statues by country, state, country and region. Integrating compliance measures into a string of business processes that cross departments and business partners can quickly become unwieldy.

Pharma, biotech and medical device companies are becoming less vertically integrated. They are 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 challenges.

For example, content creation compliance must be managed from copywriters to designers to brand teams to external marketing agencies to webmasters to field sales staff. The handoffs between these roles likely require multiple approvers, version control and audit trails.

This type of content management requires workflow processes and traceability within each company 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 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.

CRM is the customer system of record. 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 CRM applications such as Salesforce and Microsoft Dynamics 365 offer integration and workflow assignment with SharePoint and other CMSs to manage and automate regulatory compliance.

Life science CRM systems orchestrate key processes such as marketing and promotions, influencer and KOL outreach, field sales and account management, samples 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.

Life Sciences Compliance

Unlike most other vertical markets, the pharma, biotech, cosmetic and medical device sectors 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 requirements, 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. CRM with SharePoint can automate promotional materials management requirements. These include things like version control, online annotation (of text and rich media), content distribution history, 2253 form support and claims for ad reference support. They can also support for the content lifecycle of distribution/ expiry/ withdraw/ periodic reviews and support for Medical, Legal and Regulatory (MLR) reviews.

A combined CRM and CMS solution also brings sophisticated capabilities such as granular security permissions, enterprise search, file/document status, approval processing, compliance & traceability, workflow automation, integration with other business applications, and advanced reporting (such as audit trails and time-based reporting).

In fact as I've found multiple times over, a CRM and CMS combined solution strikes a balance between ease of use and full enterprise document management capabilities. This type of solution is easy to use and spans the 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 Salesforce Slack or Microsoft Teams. 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.

The participants can subscribe to the groups, topics or even individual collaterals which they want to receive or view updates in an activity stream. It's a great method to be alerted when items you are interested incur changes. And the resemblance to a Facebook or Twitter activity stream is yet another example of the consumerization of business IT.

Healthcare and life science 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 directly contribute to effective and efficient collaboration.

Certainly there are many options for automating content management and collaboration processes. But for companies which have already invested in CRM technologies, or companies with the freedom to start with a blank slate, the out of the box integration among CRM software, CMSs and enterprise social networks offer a low cost and quick deployment option to grow their customer relationships while achieving life sciences regulatory compliance in an automated and efficient way.