Taking a Content-Centric Approach in Regulated Environments


Every life sciences pharma organization struggles with the same dilemma: how to strike a balance between the exponentially growing amount of content that needs to be produced and in the market quickly with the need for auditable review that ensures compliance and reduces risk. But is this marriage between the regulation and volume of needed content even possible? Absolutely.

The ability to push content out on a global scale at an accelerated pace that’s on-brand and geo appropriate has been essential to business success over the past couple of years. But now, businesses need to figure out how to do it more effectively and efficiently from ideation through the MLR (medical, legal, and regulatory review) process.

Joining Content to the MLR Process to Increase Agility

The FDA regulations and other agency regulations around the globe for life sciences companies protect consumers and ensure that the claims made in their ads, product labels, and information provided to healthcare professionals are appropriately vetted and accounted for across their organization.

Life sciences organizations often focus on this MLR process as the start and end of their content production timeline. But it should be part of a much larger content journey that begins with the initial ideas that fuel the marketing activities. Not surprisingly, marketers can grow frustrated with the amount of time and cycles it takes for content to work through the MLR process, which may involve numerous roles and departments.

So how can organizations better align the MLR process to marketing activities to streamline both efforts?

Identify What is Considered a Risk

MLR is the last line of defense before a piece of content is shared with an audience. The goal is to mitigate any possible risk to the organization and the subsequent consequences associated with being non-compliant. However, what constitutes “risk” can vary from company to company.

The first thing you need to do as you create your MLR content management strategy is establish risk policies – both at the company and the MLR levels. Next, you must analyze and identify what is considered a “risk”– is it the use of medical information, trial results, customer quotes, graphics, photos, etc.? These will be at the top of the list during an MLR review. Likewise, you also want to identify those attributes that don’t necessarily have to go through as strict of an MLR process so you can accelerate time to market.

These discussions between marketing and the organization’s medical, legal, and regulatory experts should happen before you start creating your policies and procedures. Then, once the risks have been identified, you can build them into the overall content management process as automated workflows.

Understanding What a MLR Reviewer is Looking For 

When an MLR reviewer is looking at a piece of content, they’re analyzing it from five different perspectives:

  • Editorial: Are the numbers and statements accurate? Is the formatting correct? Is the content flowing properly?
  • Conceptual: Does the overall idea or theme make sense?
  • Risk: Does the content pose any risk to the organization? Is the content compliant with all regulations? If the content has been approved previously, have there been any compliance changes that make some part of the content now risky?
  • Consistency: Is the messaging and visual presentation consistent with the company’s brand persona? Is it similar to content created previously?
  • Context: Is the content relevant to the audience or to the platform it will appear on? Is the content appropriate for the intended use? This applies holistically. For example, you may be using a piece of modular content that has already been approved. However, if that piece is part of a larger project or experience, an MLR reviewer still needs to review how that piece is used within the larger context of the asset. 

Strategies for Streamlining the MLR Process

You can build several steps into your process to streamline the MLR content management process.

Start with the concept review
Run the idea for the content by other stakeholders and those involved with the MLR process. You will ask and answer questions like: Is this the direction we want to go? Do you have or foresee any problems? Do you have any suggested changes? This step will give those involved in the MLR process more context from the very start – they will understand the intent and how it will be used.

Use AI-based review automation solutions
These automated solutions will help you catch the smaller risk-related issues, freeing up the MLR team to focus more on the actual context and the company’s risk tolerance.

Have others do a pre-review
Ask other team members or even an external vendor pre-review the content. Their unique perspective may raise issues and questions you can address before the MLR process.

Use rule-based review
Create a checklist of rules to apply to each piece of content before submitting it to the MLR process for review.

When companies do align the MLR process to marketing efforts and leverage a fully integrated platform like Aprimo that blurs the lines between production management and content management—including for regulatory compliance, they can gain various tangible efficiencies, such as:

• Transparency
• Financial Accountability
• Audit and Inquiry Support
• Digital Rights Management
• Seamless Re-Review

To learn more about taking a content-centric approach in regulated environments, watch this video featuring our discussion with Darshan Kulkarni, legal expert, author, and podcaster!

Ready to see how Aprimo can streamline your content workflow and help you navigate regulated content bottlenecks? Start with a free trial of the Aprimo platform.

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