The Life Sciences MLR process

From regulatory necessity to business driver

Medical Legal Review (MLR) has always been one of the most challenging and complex aspects of the marketing production process for Life Sciences companies. In an increasingly global and digital world, these challenges are intensifying. Organizations need a fresh approach to MLR that enables a timely and efficient marketing workflow and allows for rapid process innovation. In this blog I want to look at how a Marketing Content Management (MCM) platform can help streamline and accelerate the MLR process.

Life Sciences marketing has always been highly regulated and we’ve always had to conduct effective MLR reviews. However, two trends are putting more strain on traditional approaches to MLR. The first is the increasing globalization of business for many Life Sciences companies. The second is the move towards digital marketing.

Today, marketing content is being deployed across the range of new digital channels. Every marketing strategy now has to involve email, websites, microsites, mobile apps, social media, video ads and conferencing, webinars and a host of emerging digital capabilities.

This means vastly more content. Research from Accenture found that 78% of marketers in pharmaceuticals and biotech and 95% of marketers in medical technology were producing moderate to enormous amounts of digital content and assets.

Effective and timely MLR becomes ever more tricky as the amount and variety of content explodes. Some companies are still struggling with MLR; while the amount of fines has fallen in recent years, Life Sciences companies in the US are still receiving fines in the hundreds of millions of dollars under the False Claims Act. It is clear that companies are finding it difficult to ensure they are providing accurate and compliant content to healthcare professionals, patients and customers.

MCM: Building on the MLR foundation

The traditional approach of establishing a Promotional Review Committee that is unaligned with other parts of the marketing production process and using highly paper-based processes cannot cope with either the volume or variety of modern digital communications. Many companies have begun to adopt digital platforms to address their MLR requirements. A recent survey we conducted with MM&M showed that, although 59% of respondents were currently using a digital platform to manage marketing content and digital assets, most digital platforms are deployed to address the approval and review stages. This is leading, according to MM&M, to almost 40% of companies planning to deploy a new platform in the future.

Figure 1: Key drivers for regulated Marketing Content Management solutions

Respondents of the MM&M survey indicated that companies wanted to build upon their MCM and regulatory compliance capabilities to improve marketing process efficiency (98%), quality control (93%) and speed to market (93%)(Fig. 1). Life Sciences organizations are beginning to explore solutions that can address every stage on the digital supply chain – from content creation to multichannel distribution to eventual withdrawal.

Figure 2: Critical user features for MLR

This was further emphasized when the research asked what were the most important features of a digital platform for marketing management. In addition to review and approval, ease of use, search capabilities, reporting and analytics and back-end integration were all seen as extremely important.

Our research suggests that organizations are keen to deploy a central digital platform, such as OpenText Marketing Content Management (MCM), to enable the sharing and collaboration on marketing content between international teams, marketing and MLR, and external agencies. The platform helps underpin effective end-to-end processes to ensure the creation of compliant content and digital assets that can be deployed across digital channels and into different markets globally.

Integrating MLR into the MCM platform

The new generation of MCM platforms provide a comprehensive solution to manage creative teams and assets through development and delivery processes. Through easy-to-deploy automation, they accelerate asset delivery, drive innovation, improve brand consistency, and control costs. In addition, the platform delivers all the MLR, quality control and process harmonization capabilities you need in one place.

MLR sits at the heart of the MCM platform allowing you to manage the entire end-to-end marketing workflow. The MLR process is integrated into the platform to allow for the alignment of the MLR team with other marketing disciplines. The MCM platform is based on sophisticated Digital Asset Management (DAM) functionality to ensure flexibility and control in how a company acquires, creates, manages and uses it digital assets. The DAM allows for approval and regulatory information to be easily added to each digital and content asset.

All claims and related information is easily appended to the asset, quickly searched and retrieved and centrally managed, while enabling assets to be securely shared and distributed between employees, offices and external agencies. In this way, not only can an organization ensure compliance in each different market, it streamlines the approval, re-use, distribution and eventual removal of marketing content.

By placing MLR centrally to the marketing management workflow, you allow it to move beyond compliance and risk to become a key business enabler. You can begin to analyze the vast amounts of data that you require during the MLR process to make your entire marketing production most effective and ensure you maximize your marketing budget and resources. Your marketing and brand managers can now quickly answer essential questions like ‘how long does it take for a piece of collateral to reach its target audience?’, ‘How much does an individual item costs and how often is it used?’ and ‘Where are the major throttle points in our marketing production processes?’.

Life Sciences inhabits an increasingly digital world. This digital world has huge potential to transform the business of healthcare professional and patients. Unlike most other industries, the accuracy and integrity of digital content is paramount. Companies understand that to ensure the effectiveness of their digital outreach and engagement programs, marketing content has to be high quality and compliant while able to be quickly created and distributed through a wide range of digital – and non-digital – channels worldwide.

Effective MLR is becoming a business driver to ensure the accuracy and agility an organization needs to meet its business objectives. A MCM platform that integrates MLR allows you to deploy an end-to-end platform to quickly and cost-effectively create, manage and distribute compliant digital assets.

If you’d like to know more about Marketing Content Management and how it can help your business, register for my upcoming webinar. It will be also be one of the hot life sciences topics at this year’s Enterprise World in July. You can book your place here.

Jaleel Shujath

Jaleel is an Industry Strategist in Life Sciences for OpenText, based near Washington DC.

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