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November 1, 2019

If, then: 4 strategies for overcoming frequent MLR and medsci review challenges

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MLR and medsci review can be challenging. Review teams are required to balance priorities, workloads, and team dynamics–all while moving advertising and promotional materials through review quickly and compliantly. Based on our experience working with life science organizations to optimize the ad/promo process, we’re sharing four strategies for overcoming common MLR and medsci review challenges. 

If: You’re getting unsolicited feedback

Often, reviewers end up providing feedback on imagery, color, or syntax–even when these elements are outside the purview of their review. As a result, the entire review process is stalled because decisions that were final are now being revisited. 

Then: Clarify roles and responsibilities

Use roles and responsibilities as guardrails for your MLR teams. Role clarity allows each individual in the review process to know the purview of their review and be held accountable to that purview. Clearly document roles and responsibilities and make the document public so everyone is on the same page. By setting clear expectations, the entire team is held accountable to the feedback they provide.

If: You’re in review meeting hell

Many PRC and medsci teams benefit from in-person review meetings to discuss and debate feedback. In-person meetings can help move reviews forward and provide opportunities to gain insight into the thought process of each subject matter expert. However, these meetings often get derailed or aren’t effective when everyone is not on the same page. 

Then: Harness the power of agendas

In advance of each review meeting, send out a brief agenda (can be as simple as a bulleted list) outlining the materials that will be discussed and any decisions that need to be made. Assign decision owners, if possible. That way, your team can walk into the review meeting prepared for what needs to be accomplished.

If: “OOO” is causing delays

We’ve all been there: a material is 75% of the way through the review process, only to get hung up because one reviewer is out of office. This is particularly troublesome when operating on a tight deadline to get materials out in advance of a conference, product launch, or other timely event.

Then: Require delegates

By requiring reviewers to assign a delegate while they are out, your team can continue to move the process forward. Alternatively, you can consider assigning specific tasks within the MLR and medsci content review process to an entire group–once assigned, that group can determine who has time to take on each request as they come in. 

If: Growth poses challenges

We hear it all the time: your business is growing, and that is creating some process challenges. An MLR or medsci review process that once worked can no longer withstand the growing number of advertising and promotional or medical information materials requiring review. Often, this struggle comes out of a process that isn’t built for scale; due to the manual nature of paper- and email-based processes, teams struggle to manage all the moving parts and maintain review cycle speed during a material influx. 

Then: Embrace modern technology

A software solution can greatly benefit your review process by establishing efficiencies that enable your team to review more pieces in less time, while maintaining compliance. But, not all software solutions are created equal. It is critical to closely evaluate your options to ensure you pick a software solution that best suits your needs. If you’re unsure of where to start, download our Promotional Review System Evaluation  template. This template will walk you through key questions to consider, such as:

    • Does the tool make it easy for submitters and reviewers to collaborate?
    • Does the tool adequately support my compliance needs (e.g., 21 CFR Part 11 compliance, eCTD submission packaging, etc.)? 
    • Can the tool integrate with other systems I use today?
    • Will the vendor support me before, during, and after implementation?

Last bit of parting wisdom? No matter your unique MLR or medsci review process challenges, communication is key. Speak up about your process challenges so you and your team can devise solutions to improve the overall health of your process. Cultivate a culture of transparency to achieve optimal collaboration, productivity, and efficiency. 

Annalise Ludtke

Senior Manager, Marketing Communications at Vodori

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