Pharmaceuticals & Biotechnology
Medical Devices & Diagnostics
Emerging
Mid-Market
Enterprise
This is a co-authored blog post between Vodori and Grace Macalino, PhD MPH of Marimac Insight, a scientific management consulting company.
For many life science companies, the MLR review process can be complicated. Teams are strapped for time as they try to stay organized, avoid compliance risk, and get content to market fast enough to support their latest campaigns and launches.
The MLR review process is unique in that it combines people and subject matter expertise from several departments, therefore effective collaboration is key for an efficient process.
For pharma, device, diagnostic, and biotechnology companies, medical review and approval is required (which often lives within medical affairs) to ensure compliant use of claims and medical information. Participating in MLR review is often just one aspect of medical affairs’ day-to-day; therefore there are things you can do to help set these reviewers up for success and make the most of their time during regulated content reviews.
#1: Brief the medical reviewer on the content they’re reviewing early
Brief your medical reviewer on the content in advance of their review. Medical claims can be made in a variety of contexts, therefore medical reviewers find the following information helpful:
- Target audience
- Intended use of the content
- If the content is new or a revision of existing content
Regardless if you’re using internal or external reviewers, the more information your medical reviewers have up front, the more efficient they can be during their reviews.
#2: Provide due dates up-front
Because promotional review isn’t the primary focus of medical affairs’ day to day, communicating due dates up front is essential. Communicate context behind the review request: is this piece of content part of a campaign? Essential for a launch date later this month? The clearer the expectations, the better.
If you’re using promotional review software, communicate due dates within the system or as prescribed by your standard operating procedures (SOPs).
#3: Organize your core claims and references
Organize your core claims and references, whether in your promotional review system or by using a core claims document. It’s also helpful to communicate if the claim is brand new or has been used in prior content, as this will help direct your medical affairs teams to the right elements within the content.
The key to effective collaboration with medical affairs? Clarity and context. Have conversations with your medical affairs team–whether internal or outsourced–to hear directly from them on how they want the review process to go and what information they find helpful. The more you can do to get on the same page, the better.
If you don’t have the internal resources to accomplish this, you may consider seeking outside support from a firm with experienced medical reviewers and medical affairs leaders.