The medical legal review (MLR) process is a pivotal part of functioning medical communications team projects. Often, delays and setbacks can occur that adversely impact the cycle of a project. This can create a downstream effect which hinders the ability of an agency to adhere to strict timelines. Clients are then unable to utilize and showcase materials in a timely manner. It also requires teams to have to regroup (many times more than once) to manage changes in scope and redirection of project ideas. How can a team navigate these challenges to deliver timely and quality work?

Take advantage of consults or workshops with the review teams

I have witnessed first-hand how effective an initial meeting with the review team can be. This gives a chance for the agency and client to ask questions of reviewers on likely challenges to a project. The team can also adequately anticipate and gauge how the review process may progress. The reviewers can give valuable consultation from medical and legal perspectives. It might also be helpful to share initial ideas visually or provide similar examples of materials already approved. Understand that many review teams follow unique MLR steps and guidelines. Thus, it is important to work with the teams to embrace the best way to have everyone collaborate and discuss guardrails before a piece can be put through the formal review process, if possible.

Discuss comments with your team/client ahead of a review

Getting ahead in the MLR process can give the team an advantage in navigating submissions and approvals. It can be useful to flag potential concerns to clients beforehand, even prior to submission. Realistically, if comments are released prior to meeting with the review team, this allows the scientific team to identify and anticipate areas to focus on during the review. When you can pinpoint comments to focus on, you can direct discussions. Keeping in mind the limited time of a session, an effective practice would be to formulate ideas and evidence for potential push back or negotiation.

Communicate any concerns or queries in a timely manner

MLR reviews tend to operate under strict deadlines. Not to mention, internal and client expectations need to be managed. It is essential to maintain open communication with the review team during reviews, as well as between reviews as needed. Miscommunications and/or incomplete resubmissions can delay the process further. I have seen successful use of email chains post-review to clarify specific comments or flag any other concerns before a resubmission. It may also be helpful to suggest a short touchpoint with a reviewer if further clarification is needed.

Use your communication skills and foresight to your advantage. The MLR process can be challenging, but if managed properly, can help teams build trust and partnership with clients.