The Medical Legal Regulatory (MLR) review process is inescapable, but it doesn’t have to slow you down.
With digital tools and technologies available, and pharma companies pushing their digital maturity to higher levels, the MLR process can even become streamlined and agile!
This guide recaps the main challenges you may be having with MLR approval and details our top tools and technologies for speeding up the process while remaining compliant.
The challenges of slow MLR in pharma
If you’re dealing with MLR, you’re likely already aware of the challenges posed by slow processes (in fact, slow MLR review is one of the main challenges for digital marketers), so we won’t go too much into detail here. Instead, let’s briefly recap these challenges to make sure we’re all aligned.
| Problem | Cause | Details |
|---|---|---|
| Delayed campaign launches | Approval bottlenecks | With multiple stakeholders involved, getting marketing campaigns approved is slow |
Missed market opportunities | A slow MLR process can prevent you from quickly responding to market opportunities | |
| Reduced agility and flexibility | Inflexible content | Even the smallest change means redoing the entire MLR process |
| Inability to test and learn | Slow MLR processes make it difficult to test different approaches and iterate quickly | |
| Reduced personalisation | You cannot personalise marketing based on customer data and feedback quickly. | |
| Compliance over innovation | Risk-averse culture | Compliance is valued over innovation, limiting experimentation and risk-taking |
| Conservative content | The MLR submission process leads to content that lacks creativity and has low engagement | |
| Increased cost | Resource intensive | Significant time and effort are required to run through MLR, reducing overall efficiency |
| Opportunity cost | Resources that could be used elsewhere are tied up in MLR | |
| Inconsistent global execution | Localised approvals | Global campaigns require local MLR approvals, leading to inconsistencies |
| Coordination challenges | Coordinating across markets adds further complexity and delays to your strategy |
The key to overcoming these problems is to streamline your MLR review processes – ideally through adopting more agile compliance frameworks and aiming for digital transformation.
Let us explain how.
How Digital Maturity Speeds Up the MLR Review Process
Digital maturity involves utilising the latest technologies and tools, staying up-to-date with trends and continuously striving for improvement. With these technologies and tools, you can find new ways to speed up MLR while remaining compliant.
AI and Machine Learning
Currently, it may take you two months (or longer) to get your materials through the MLR approval process. In that time, trends have moved on and customer interests may have shifted – particularly on social media channels.
Speeding up the creation, review and approval of your pharmaceutical marketing materials can only benefit you. AI could be the way to do this:
- Content Creation: although AI should not be relied on to create content, it can be useful for compiling assets, organising data, recommending materials, and even idea generation.
- Pre-MLR Checks: AI can process data incredibly quickly, identifying issues in documents and suggesting ways to reword content to meet MLR requirements. Having AI do a preliminary compliance check can help you earmark unproblematic content to fast-track through MLR while more complex and problematic content can be given more attention.
- Preventing Duplication: has this content been approved before? If you’re working with modular content (and you really should) you’ll likely have a vast library of MLR-approved content. With an endless memory and fast data-reading capabilities, AI can prevent unnecessarily sending content through MLR processes when similar or identical content has already been approved.
As explained in more detail by Behsad (phamax Digital CEO) on LinkedIn, AI can speed up the MLR content approval process by 2 to 3 times!
This streamlining can significantly reduce time-to-market, giving you a competitive advantage.
Indegene estimates that 80% of review and approval responsibilities can be handled by AI, while the remaining 20% (often higher-risk content) needs the human touch.
Modular Content and DAM
A digital tool we strongly recommend is a Digital Asset Management (DAM) system. Here’s how they work to speed up the MLR review process:
- You create modular content (individual images, videos or text, for example).
- These modules are approved through an MLR review.
- Pre-approved content blocks are uploaded to the DAM system.
- Your marketing team only uses content that’s organised in the DAM system, thus ensuring that all content created is MLR-approved.
New to modular content? Start with our guide to modular content in pharma!
Not only does using pre-approved content blocks mean you can reuse different materials across campaigns (saving resources and your budget), but it also reduces the number of MLR reviews you need to go through.
One of the most popular DAM systems is Veeva Vault PromoMats, but there are other options available.
When you’re setting up a DAM system, look for one that offers version control. This keeps all team members working on the latest version, reducing errors and confusion. You should also make the most out of automated workflows and real-time collaboration tools, to further streamline reviews and approvals.
DAM systems can also offer search capabilities and manage compliance through detailed metadata and automated alerts. Think of it like a CRM but for your content. Like a CRM, many DAMs can integrate with other tools that you’re currently using.
Collaboration Tools
You’re likely already using a collaboration platform, whether it’s simply group chats on Slack or a project management tool like Asana, to reduce the back-and-forth of email communications.
Don’t underestimate how effective these tools can be for real-time collaboration among global MLR teams too.
Utilising these tools allows your teams to simultaneously review and edit documents – including both marketing and regulatory teams, which are often siloed. Giving these teams a channel for instant communication not only speeds up the review process but also kindles an understanding of how the other team works.
E-Learning and Training
A Learning Management System (LMS) is integral for keeping all your teams knowledgeable on compliance. When your marketing teams are up-to-date on the latest compliance rules, they’re less likely to create uncompliant or high-risk content which clogs up the MLR process.
Rather than simply organising a meeting or slides to teach team members, an LMS streamlines the process and provides a central place for training and documentation.
This is absolutely crucial for pharma companies with teams in different jurisdictions and markets – when regulatory changes are made, the LMS provides automatic updates and reminders for training.
And, beyond MLR, e-learning has serious advantages for your company. The American Society for Training and Development found that companies that utilised comprehensive training programs had 218% higher revenue and 51% of employees noted that e-learning affected their workplace happiness.
Data Analytics and Reporting Tools
Our last digital tech you should take advantage of is data reporting and analytical tools, like Power BI. This business analytics tool from Microsoft can be used to analyse MLR data, identify bottlenecks that should be addressed, and measure Key Performance Indicators (KPIs).
The key is to take a mindset of continuous improvement. Your MLR processes can always be a little faster, a little smoother, and even more accurate. This tool analyses your data to give you the insights to do this.
For pharma companies with high digital maturity, these tools can also enable them to use predictive analytics. This can be used to predict potential delays or compliance risks before they arise, enabling proactive MLR management.
Next Steps
The MLR submission process can be streamlined, but it requires the right tools and a little effort. The results will save you time, money and a whole lot of frustration. So, it’s certainly worth it!
If the tools and technologies listed in this guide seem too far out of reach for your current capabilities, we strongly recommend you take the phamax DMMI (Digital Marketing Maturity Index) to assess your current digital maturity and receive personalised guidance on how to move forward.
