Regulatory Processes are All about the (content) Journey

As life sciences companies continue to streamline and look for ways to be more agile and efficient in a rapidly changing market, they sometimes look to evolve the (usually) long and (often) complicated processes they use to review, approve, and submit promotional material subject to regulatory compliance.

This medical, legal, and regulatory (MLR) process is vital to minimize financial, legal, and reputational risks inherent to the production of drugs in the life sciences sector. Similarly, the regulations help to ensure consumers have access to accurate claims around drug efficacy, side effects, and other pertinent information that may influence consumers’ decisions.

How The MLR Process Connects To Content

The FDA regulations and other agency regulations in place around the globe for life sciences companies are there to protect consumers and to ensure that the claims made in their ads, product labels, and information provided to healthcare professionals are properly vetted and accounted for across their organization. We certainly want to be confident a TV ad saying that a drug is “20% more effective than its competitors” is accountable for that claim, including any of the research behind it.

Life sciences organizations often focus on this MLR process as the start and end to their content production timeline. But it’s really just part of a much larger content journey that begins with the initial ideas that fuel the marketing activities that will be planned for the coming year: maturing products, new therapeutic areas for existing brands, and new product launches.

Unfortunately, many organizations often overlook the fact that their MLR process of ensuring the integrity of those ads should be considered one small part of their overall content management strategy.

They begin to produce content independent of such processes, though much of it must be sent through the MLR process and submitted to regulatory agencies. This misalignment means the MLR process and marketing efforts are working in conflict with one another.

So, why aren’t they managing all of that content centrally from the beginning?

The Benefits of MLR Content Management

When companies do align the MLR process to marketing efforts, and leverage a fully integrated platform 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
  • Fully Integrated Localization Support

Let’s look at each of these benefits individually.

Transparency: A Direct Benefit of the MLR Review Process

Removing the MLR process from a black box and allowing enterprise visibility into the process makes the entire organization more efficient. At a global level, transparency can reduce agency costs, prevent unnecessary work, and significantly reduce cost. Further, having readily available globally approved content can enable marketing leadership to better understand the ROMI of all content produced.

Financial Accountability: An Outcome of the Medical, Legal, and Regulatory Review

Does your company know the full cost of putting content into market? Aprimo Plan & Spend, for example, couples the financial performance of a piece of content with the overall production and approval process. These shouldn’t be tracked separately – they are facets of the same corporate objective: managing costs while increasing value.

Audit and Inquiry Support with MLR Content Management

Answering regulatory inquiries or responding to audit requests shouldn’t send your organization into panic mode. With centralized MLR content management and a strong production management and financial management platform underneath, answering inquiries of any kind becomes a non-event. You’re responding to these inquiries in a matter of days with a small team mentality, instead of having to rally the troops and get the whole office annoyed when you block off the “good” conference room for a week in order to respond.

Digital Rights Management Reduces Risk

With tight integration to FADEL, Aprimo ensures that contracted digital rights usage restrictions are properly managed. This reduces corporate risk and helps avoid fines for misuse, especially when you’re doing event sponsorships or working with celebrity content. Understanding usage restrictions and controlling who sees what is more nuanced than just locking down a shared drive.

Seamless Re-Review of Managed Regulatory Content

Regulations limit the approval window during which content is allowed to be put into market and managing the re-review process can add lots of complexity to your overall content strategy. But what if you had a solution that automatically tracked a pre-set number of days before expiry? And if expired assets were seamlessly removed from visibility (but not deleted, of course) without manual intervention? How much time and effort would your organization save?

Fully Integrated Localization Support of MLR Process

The ability to quickly localize and support translation of content into various languages is key to reducing costs and increasing efficiency. This type of project represents a significant portion of the annual workload for a life sciences company, but the need is a tricky one if there isn’t an enterprise content solution in place. Derivative and related content pieces need to be tracked and managed together even when localization doesn’t occur right away. In fact, the challenge becomes greater the more languages or countries that are involved, because the usage and re-review dates may differ based on when a piece of content enters the local market. Are you able to easily the expiry of an asset used in approved localized materials still within their approved usage window?

The Big Picture: Joining Content to the MLR Process to Increase Agility

What it comes down to is that solving only your “MLR” problem misses the management of the entire lifecycle of your content. Managing the entire content journey, and MLR along with it, provides the organization with a level of seamless integration, transparency, and financial accountability that aligns with goals showing up in annual reports: brings more value to patients and consumers, reduces the cost of producing that content, and helps your organization become a more efficient company.

About the Author

Brett Molotsky is Aprimo’s Vice President of Industry Solutions. He has spent the majority of his career helping enterprises leverage technology to meet customer needs while enforcing compliance with internal and external policies. As a thought leader in this space he has published several articles and has authored a book on applying business requirements to technology solutions. He currently resides in Southern California and has been with Aprimo since 2006.

More Content By BRETT MOLOTSKY
Brett Molotsky, Vice President of Industry Solutions, Aprimo
 

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