Future Proof Your MLR Review and Approval Process
Drug approvals have risen sharply in the last few years and, accordingly, so has the demand for content to support the marketing of these new medicines. Veeva Pulse Metrics data shows that pharma companies increased their content asset production by 37% in 2021 alone. MLR teams are trying to keep pace with the increase, reviewing more content with the same amount of resources.
Regulatory guidance on drug promotion doesn’t tell emerging life sciences companies how to do promotion reviews in a cost- and time-efficient manner. For that, there are best practices and content management platforms. The right review and approval process will set a company up to document every step and to publish all needed materials in a timely, compliant fashion. Companies that have optimized their MLR workflows have seen a 57% reduction in review cycle times and a 55% drop in time spent in review meetings. Here are some key steps to take to optimize workflows, enhance internal collaboration, and establish a single source of truth.
Setting the foundations for efficient MLR
To establish effective and efficient MLR reviews, begin with governance and process. A best practice here, as my colleague Gina Sanders recently outlined, is a framework that has representation from every group involved in your content strategy. Your framework should also define the systems and processes to review and manage the content. You need to understand who should be at the table and who ultimately owns the decision around any changes to your process.
As therapies become increasingly tailored, the content that promotes them will need to be very different from the mass-market messaging of the past. You should consider a modular content strategy and a review process flexible enough to manage narrowly targeted content efficiently.
Making the right staffing decisions for your MLR reviews
Emerging companies have limited budgets for every aspect of their operations, including review and approval. You should think about whether you want to hire full-time employees or begin with an outsourced model.
While your medical reviewer will likely be on staff, it is very common for a young company to turn to a consulting firm for regulatory reviews. Look for one with experience in your therapy, product, or device area and ask about its background in the local, regional, and global markets where you will need to make filings and win approvals. You should also make sure that it is comfortable with using your review platform and that it can scale to meet your needs.
Your legal review team may be outsiders on retainer or billing by the hour. Given the cost of that time, it makes sense to channel legal work through a purpose-built technology solution so that time is not wasted.
“With Vault PromoMats, we were able to streamline our MLR review and approval process. Our various stakeholders can now simultaneously review content in a timely manner while making sure it complies with all the applicable codes and regulations.” Irene Buesa Escriba, Global Promotional Compliance Specialist– Global Compliance & Privacy, Almirall S.A.
Streamlining the process with fit-for-purpose technologies
Established pharma and biotech companies commonly turn to technology to accelerate the creation, review, and approval of their content. Emerging companies can benefit from creating a strong content foundation with MLR and digital asset management (DAM) systems.
A dedicated MLR system will move you beyond the cumbersome paper processes of the past and keep reviews flowing even when reviewers are not all at the same location: Documents are held in a central repository that everyone can access, including contracted reviewers and your agencies. A modern MLR system should have a built-in library for effectively managing both claims and references. This can cut both the administrative burden around maintaining your claims library and your claim management risk across countries, channels, and assets.
“We wanted a system that was suitable for every country but wouldn’t have to be overly customized. Vault PromoMats gives us the global collaboration and automated audit trails we need, while gaining the flexibility to adapt to edge cases as they arise.” Agnès Keltie, Compliance Manager, Global Medical Affairs, Norgine
A strong MLR system should support and automate controlled compliant activities that increase the speed of review, submissions to authorities where required, and content speed to market. Finally, look for an MLR system with flexible review workflows so that you can meet your organizational needs as you scale.
Scaling content development with Digital Asset Management
DAM systems are also foundational to a scalable content development and review process. They organize all the text and graphic elements related to your content and provide an approved library for your agency partners to access and build new content rapidly. DAM systems hold metadata and rights information for every content element and if an asset is later reused in another channel or content format—a best practice to maximize your content spend—you’ll have full visibility into previous MLR approvals, so you’ll know when it was last vetted.
MLR reviews have always been a critical element of marketing operations at life sciences companies. That will not change, but the days of doing them all on paper, email, or spreadsheets are over. Embracing a purpose-built MLR system now can enable you to better manage the process, make it more efficient, and prime it to scale as your company’s needs grow.
Learn more about making your company’s compliant medical, legal, and regulatory reviews faster.