How to Solve MLR Hurdles with a Modular Approach

As the unstoppable technological progress flow changes the focus of our daily lives, it also introduces a fresh approach to the field of digital interactions. It becomes quite a challenge for life sciences organizations to keep up with modern marketing trends, especially concerning the highly regulated and compliant pharma and life sciences industries.

If you are familiar with anything that is described as MLR review, you probably already know what it means. This acronym represents “medical legal and regulators review” — a process used in which life sciences companies ensure the compliance of their marketing and promotion materials with internal and external regulations and guidelines. Your business can use another name such as MMLR review or MRC review.

What is Modular Content?

A typical pharmaceutical company spends a massive amount of time and money creating an efficient marketing workflow that needs to go through the medical and legal regulatory review process to get approval later. This approval is the bottleneck moment in the marketing production process. If the medical, legal, and regulatory representative finds the marketing materials accurate, you’re a winner. In any other case, they send your great content back, and you spend more time and money editing the information provided. Essentially, the back and forth complex aspects of this feedback are the worst scenario for marketing content management with strict deadlines and a personal nightmare for content creative teams.

This is where the modular content idea comes into play for pharma and life sciences companies and medical legal review MLR for short. The name should speak for itself: basically, a modular content strategy is built around a block of content that describes different data. Although it sounds simple in terms of marketing operations, this solution allows easy access for the medical legal regulatory review. It directly impacts the compliance and review processes.

The modular content approach helps management spend less time and effort on content creation, not to mention the savings for the organization. In this article, we will discover what modular content is and how it helps to solve typical MLR hurdles for marketing content management.

If you know anything described as an MLR review, you probably already know it. This acronym represents “medical legal regulatory review” — the MLR process in which life sciences companies ensure the compliance of their marketing and promotion materials with internal and external regulations and brand guidelines. MLR reviews are sometimes called MMLR review or MRC review – your business may use either one to describe regulatory compliance.

The solution to the MLR review process

Content creation takes a lot of time and money, and marketing teams spend a lot of resources trying to find an idea and make it attractive as well as sales-worthy for healthcare providers and the life sciences industry as a whole. When this highly creative and useful content gets cut or even declined by the MLR reviewers, it becomes a major pain for the entire marketing department or even the company. This pain is associated with hindering many processes in the organization, impacting the marketing production process, missing deadlines, work-overs, limiting efficient marketing workflow, and more budget spending.

MLR review solutions can be unpredictable, so the modular content was created as a fresh approach to overcome typical MLR process hurdles. This approach makes the life of both MLR review team and content management creative teams – easier.

A module is a stand-alone piece of digital content that consists of the main claim and supporting text or media.

• The easy-to-use blocks separate the content inside the module.
• These blocks can be predefined and organized according to the main content requirements and used in various forms, from SMM content and emails to interactive presentations like an eDetailer.
• Among the many advantages of the modules is the possibility of quick MLR reviews approval.

Life Sciences Companies’ Problems Solved

Time

A large amount of original and creative marketing content management takes time to be created and thus approved. It can take up to a few weeks for MLR reviews and its representatives to check the compliance and approve every page or piece of your training materials or guidebooks. Suppose, for some reason, the medical legal and regulatory approvers declined a significant amount of content. In that case, you need to launch the production cycle once again: content needs to be reworked following the medical legal regulatory review solution and applied to the MLR review for approval once again. If everything is fine this time, you get your smooth process ready to go. Otherwise…welcome to yet another round.

So, a module is a great solution to eliminate the many complex aspects — it needs to be approved to fit compliance and regulations only once. When it comes to creation, it won’t take time to use prepared assets and templates. Your organization needs to align it with the regulatory policy and send it for review. Once approved, such a module is automatically highlighted for medical legal regulatory compliance representatives, reducing the risk of MLR decline and starting rapid process innovation for life sciences and healthcare professionals.

Workload fatigue

Workload fatigue is simply a human factor in content management. When you begin to research and write a large amount of information, your eyes may get clouded with words and digits, and anyone in the organization can make an unconscious mistake. This is an unfortunate part of the process for both MLR and content makers: when the marketing team spends weeks creating something useful and original, an exhausted copywriter or designer makes one mistake that entirely spoils and wastes these work hours. Another example: a stressed and overloaded with tons of work regulatory compliance representative declines some presentations because of some small things they found incorrect. Both cases aren’t pretty for management in the face of processes like missing deadlines and budgets.

The good thing is that module is built on expertise and templates. Template structure makes it easy to create and edit. Also, it uses only pre-approved information for medical regulators, so there’s no need for additional research or a second check once the module is approved. Such simplicity reduces the possibility of decline because of incorrect information or human error; accordingly, it makes the regulatory compliance i.e., MLR process, faster.

Global to local scaling

The pharmaceutical business is something that can be scaled up and down. Whether your company works globally or locally, each market has its own medical legal regulatory specifics in different territories. So, every time the management needs to reposition your product in a different country or state, you must change your marketing strategy to follow the local specifics and compliance requirements. It can become a real struggle for the management and content team to re-target the materials for a new market and apply them to MLR review as the content needs to be compliant.  

Again, the structure of modular content is flexible when it comes to changes. The blocks, templates, and informational fields drive rapid process innovation and can be easily replaced with the required ones while still be in compliance with MLR standards because of the pre-approved and localized content. 

Different HCP fields

It may happen to promote one product in different HCP fields. For example, if you are going to promote the same treatment for different medical fields like endocrinology and gastroenterology, the MLR process will be applied for both directions separately. It requires additional expenses for the management on content creation and doubles the risk of being rejected by MLR in pharma, as each medical field has its requirements.

At this point, the module also can be adapted accordingly to the specific case. To avoid many regulatory affairs, you can create a separate module template personalized for different cases and pre-approve it accordingly. 

Outcome

As you can see, the modular content is quite a solid solution to the most common problems related to the MLR review process. The pharmaceutical industry is highly regulated, and thus, the medical legal regulatory process is very demanding for a business presentation, marketing, and promotional materials. Such circumstances make it difficult to develop high-quality content, adapt it to different MLR requirements, and avoid losing time and money.

This is where modular content changes the situation. It is flexible, smart, and easy to develop for every case. The simplicity and interchangeability of data inside the module is the core idea that makes modular content a good communication tool that makes the medical legal regulatory review process easy and predictable.

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