If You Build It, Will It Work – And Will They Come?
The Medical, Legal and Regulatory (MLR) review process is undeniably one of the most critically important and dauntingly challenging business processes in the pharmaceutical and life sciences industries. It’s fundamental – central to every marketing production initiative in those spaces.
In essence, the MLR process is critical toward minimizing an organization’s financial, legal and reputational risk as it releases drugs into the marketplace. The MLR process ensures that claims regarding drug use, efficacy and side effects are in compliance with all medical, legal and regulatory requirements.
The stakes could not be higher. For example, fines across the pharmaceutical industry related to the False Claims Act total in the billions of dollars, with individual firms often penalized millions of dollars per infraction. In addition, resulting consumer backlash can sometimes cause brand-related damage that lingers for years.
So, getting the MLR process right is crucial.
Functionally, the MLR process must rigorously control and execute review, approval and document filing actions. But that’s only part of the story: in the end, marketing production users also have to use it, adhere to it, and embrace it.
In short, MLR process design and implementation is key – but so is adoption.
Defining, Automating & Adopting an MLR Process
Our client is one of the 10 largest pharmaceutical companies in the world. Accordingly, they implemented an MLR review process to manage compliance and regulatory checkpoints and to automate associated regulatory filings such as Form 2253, among others.
This was a massive undertaking: our client’s MLR process served both their US, Latin American, European and Middle Eastern operations, took almost 2 years to implement, targeted 63 different markets, included hundreds of required compliance checkpoints, and served nearly 4,000 users in marketing and related teams.
But upon rollout, it didn’t go very well.
The solution proved to be overly complex, unreliable and unstable. This led to user confusion, lack of confidence, and reluctance.
As a result, the client asked the EMMsphere team to come in and help them tackle 3 key challenges:
- Process Standardization and Stability: process complexity and automation problems meant work was not properly routed, and the process itself often stalled or froze.
- Real-Time Visibility and Reporting: process inconsistencies across markets prevented real-time project milestone and status reports from being generated and regulatory filing status from being displayed.
- User Enablement and Adoption: the solution’s complexity and incomplete functionality (that still required manual activities to be done outside of the automated process), coupled with little investment in user training and learning, caused low levels of user sentiment and adoption.
Achieving Process Standardization and Stability
Upon arrival, the EMMsphere team’s most pressing challenge was to analyze the existing MLR process and diagnose the root causes of complexities, inconsistencies and technical issues around the MLR automation logic. This entailed understanding what the original intent of the MLR process was, and pinpointing where the current implementation deviated from that originally planned methodology.
The next step was to catalog all of the necessary process variations and MLR approval requirements for all markets, and synthesize everything down to a standard workflow that could serve all markets, all teams, and all MLR control points.
The final step was to focus on process efficiency and streamlining. Working with the client, the EMMsphere team carefully distilled the existing flow into a revised process that could meet the client’s MLR requirements while also achieving significant executional efficiencies from start to finish.
Key results achieved with respect to Process Standardization and Stability include:
- Process Standardization & Consistency. Our team consolidated dozens of process steps across markets and eliminated redundant tasks to define a standardized and streamlined core MLR process to serve the needs of all markets, from which minor variations for particular markets could be based.
- Terminology Standardization. In collaboration with the client’s process experts, our team defined a process and data glossary that was employed across all MLR-related activities for all markets to reduce user confusion.
- Simplified Routing Logic and Automation. Our team cataloged where process variations were needed and defined triggers for automatic branching to ensure proper routing of work items to the right roles.
- Data-Entry Sequencing & Simplification. In collaboration with the client’s process owners, our team helped to re-define what data was collected, and when, along the overall MLR process to reduce data-entry duplication.
- MLR Review & Approval Control Points. Working with the client, our team identified a definitive array of review and approval control gates, including key milestones, ensuring that regulatory mandates were strictly followed and filings properly submitted at exactly the right points along the process.
- Execution Speed and Efficiency. By eliminating routing errors, streamlining work items, rationalizing data-entry and automating the invocation of market-specific process variations, the client was able to dramatically improve overall process stability and reliability while accelerating end-to-end MLR cycle time by 20-40% across most markets.
Achieving Real-Time Visibility and Reporting
Given the client’s widely dispersed marketing operations across dozens of countries and thousands of users, their MLR requirements had to be centrally monitored for compliance purposes. To that end, real-time visibility into MLR execution was a critical need – and a glaring deficiency.
Specifically, there were 3 areas of visibility the client needed to improve.
- First, the client needed global visibility across business units and markets.
- Second, the client needed the ability to track progress along the MLR process, monitor resource capacity constraints and view status reports across key milestones along the process.
- And finally, in order to facilitate their own internal continual process improvement program, the client needed comprehensive metrics around MLR execution including cycle times, number of review approvals and remediations, and volume and duration of regulatory filing submissions.
To provide all this information, the EMMsphere team worked alongside the client’s MLR leadership team to define a complete set of reports, views and dashboards to ensure the required process data, milestones and metrics could be captured and displayed, both on a scheduled basis and real-time.
Key results achieved with respect to Real-Time Visibility and Reporting include:
- MLR Status Reports. By standardizing the core MLR process, the EMMsphere team incorporated consistent milestones and data-capture to provide a unified display of MLR status information across all business lines and markets.
- MLR Filing Submission Reports. The client’s MLR compliance team can now view comprehensive regulatory filing information including duration and outcome.
- Report Production Efficiency. By automating the generation and distribution of key MLR reports, the EMMsphere team was able to free up client resources previously dedicated to manual report production, saving 1-2 man-days of effort per week.
- MLR Variance Reports. With EMMsphere’s expanded reporting, the client can now generate time-series, variance and trend reports to monitor continual MLR process improvement.
- Compliance Exception Reports. With client collaboration, EMMsphere also developed summary reports to identify compliance and regulatory exceptions (including remediation steps taken).
- Audit Logs For MLR Governance & Conformity. EMMsphere adjusted the MLR audit logging rules to ensure complete and proper data is being captured to conform with the client’s governance and compliance guidelines.
Achieving User Enablement and Adoption
As noted earlier, overall MLR process design, implementation and testing is crucial – but so is user adoption. Unless users actively embrace an automated MLR system, all the technical wizardry it includes really won’t help too much.
In fact, without robust user adoption, the organization’s exposure to business, financial and legal risk could even increase.
This was a possibility the client was keenly aware of – they realized the organization had under-invested in user training, and hoped to dramatically improve adoption going forward.
Therefore, in addition to providing process standardization and stability improvement, EMMsphere also defined and delivered a comprehensive MLR Process Training and Enablement Program to the client’s entire user base – nearly 4,000 of them.
This effort entailed deep collaboration between EMMsphere and client team members, from both their business management and user constituencies, across markets and lines of business.
Over the course of the entire enablement program, EMMsphere defined and standardized the learning curriculum, prepared materials and case examples, developed a library of e-learning modules for remote users, and conducted a complete series of training courses across constituencies and markets.
Key results achieved with respect to User Enablement and Adoption include:
- Understanding of Overall MLR Process. With process consolidation and stability improvements in place, EMMsphere developed and presented overviews of the end-to-end MLR process to instill holistic, contextual and visceral understanding of MLR across user constituencies.
- Definition of Process Roles, Responsibilities and Expectations. EMMsphere cataloged clear definitions of specific roles and activities for participants across the MLR process.
- Curriculum Development. Working in collaboration with process leaders and market-specific teams, EMMsphere prepared a comprehensive enablement program definition, goals, topics, lessons and schedule of events.
- Training Execution and Enablement. The EMMsphere team conducted extensive end-user training classes as well as train-the-trainer sessions to leverage the client’s own learning resources across markets.
- User Help & Support. EMMsphere dedicated extensive resources to provide real-time end-user support for questions, issues and instruction.
- MLR Learning Center of Competence. EMMsphere codified all enablement materials and case examples into a series of structured modules to be leveraged by the client’s own learning and training departments going forward.
- MLR Process Feedback & Enhancement Program. EMMsphere instituted an organization-wide feedback, suggestion and enhancement request mechanism to encourage ideas for MLR process improvement – and to ensure consideration and responsiveness to user concerns.
About EMMsphere Services
EMMsphere is an end-to-end marketing solutions technology consulting and managed services provider. We offer a comprehensive array of services to help large organizations define, build, and maintain alignment across their marketing operations in order to successfully achieve their ultimate destination.