The Road to an Efficient Medical, Legal and Regulatory Review Process

You have a challenge ahead of you.  You've been recently tasked with helping launch a new product into a new market. Whether your role is in communications, marketing or medical affairs, you need to hire people and create a compliant content review process in addition to actually helping launch the product. Your time and resources are scarce, so where do you begin?


We wrote this article to share some of the best practices our customers have applied to address this exact problem.


One rule of thumb to keep in mind is that finding and fixing errors takes time. As a result, emphasizing specific processes that improves accuracy and reduces errors will save you time and expenses.


Another organizing principle is that some people’s time is more valuable than others.  You do not want to waste the time and patience of your executives, legal counsel or key opinion leaders by having them find typos, out of date information, or off-brand content.


Finally, keep in mind that unplanned occurrences will happen and your team will need to adjust quickly.  Team members will quit, get promoted, fired, go on vacation or will be unavailable more than you expect.  You need to have a process that can accommodate unexpected changes and allow you to adapt and meet your deadlines in a compliant way.

Key Requirements of any MLR system:

Ease of Use and Adoption

It is an unavoidable fact that all review team members have other important work responsibilities.  Executives, lawyers and KOLs are particularly pressed for time. Ease of use/User adoption is ranked the number one priority for any new Medical Legal and Regulatory review system. This explains the persistence of inefficient and non-compliant email based review systems - at least (almost) everyone already knows how to use email and Word.

Download Sample Promotional/MLR review software requirements

The better solution is to have an easy-to-use compliance review software platform, as well as staff who are dedicated to a defined onboarding process. A successful onboarding process, one that includes customized training and the successful completion of actual projects, is the most important step towards long term user adoption. With limited time and resources, it is difficult to pull off a successful onboarding process alone. To achieve this, you will need a Customer Success Team that knows the software platform to help drive adoption.

Structure and Flexibility

Your review team and specific approval process must be customized to your individual needs while remaining flexible enough to accommodate reviewers who come and go or who are temporarily unavailable. This helps to explain the persistence of inefficient and error prone email based review processes - they are flexible if nothing else.


A big part of any solution is a dedicated customer success team (CST).  Having a CST on board that is familiar with your team, their objectives and the software platform can help you unblock quicker than anything else. Any system that requires you to seek assistance from an internal or third party IT team that is unfamiliar with your team members or their goals is, at best, suboptimal.


If a compliance review system requires IT involvement every time someone leaves or joins the review team, you should search for another solution.  

Download Sample Promotional/MLR review workflow diagram

Tight version Control

Version control and having a single source of truth are two areas where email reviews tend to fail. While working against a deadline, email-based approval systems rely on one dedicated person to consolidate comments provided by multiple team members on different versions. Errors are unavoidable and costly in these situations. Any review platform must, at the very least, allow content owners and project managers tight control over what version the team sees and can comment on as well as which comments get applied.


Automation

Automation can help in two familiar ways and one new one:

  1. Automation of repetitive tasks can improve speed and accuracy by reducing data entry errors.
  2. Automation of reminders can nudge your review team to take action when it is needed and not when it is too late.
  3. The new frontier of automation is Artificial Intelligence (AI). With enough data and context, AI can assist with a wide range of tasks and help users complete them quicker and with greater accuracy.

The highest level of automation success occurs when the software platform is customized to your business needs as you are using it.  Any system that requires months of configuration before usage is problematic at best.


A better solution is a software as a service (SaaS) provider that keeps listening and adapting after you have finished onboarding.  Ongoing analytics will allow you to identify bottlenecks in the process. Afterwards, you and your SaaS partner can work on solutions together.


Remember:  “Measure what Matters” 

Having an idea of what success looks like and measuring your progress is half the battle.  Don’t worry about measuring everything. To establish a baseline, start by measuring the first three metrics listed below. Move on to the fourth metric if the first three aren't trackable. The fourth metric is a little easier to understand and will provide you with some insight into how well your MLR process is performing.



About Papercurve

Papercurve helps streamline compliance reviews in regulated industries like cannabis and life sciences. Manage approvers, comment, reference attached documents and archive past versions for audit – all in an easy to use interface.

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