Drug Development 101: How to Build a Good Review Team, Tip #2

We at Acumen write a lot of documents and work with many cross-functional teams. We get a front row seat to see what works (and what doesn’t) when it comes to document development. Before building a document, you need to build a review team which basically boils down to the following:

• Keep it lean

• Stay in your lane

• Know your roles and responsibilities

• Set realistic expectations

Staying in Your Lane

Another hallmark of a highly functioning review team is that each member focuses their review on content within their specific area of expertise. Comments and edits from reviewers who are not knowledgeable about specific content areas are disruptive and lead to unnecessary expenditure of time on discussion and reconciliation. Some functions, such as Stats and PK, have very clear sections of content on which to focus their review. Other functions, such Medical, Regulatory, Pharmacovigilance, and Clinical Operations, may have a broader purview. Nevertheless, it is important for reviewers to defer to their colleagues who are considered the SMEs for specific content comments and edits. 

Advice: At document kickoff, ensure all reviewers understand their area of focus. Team members should ask themselves why they are reviewing a particular document and focus their efforts on sections containing content within their discipline. Instruct reviewers to keep their comments and text changes substantive and not to bother with spelling and punctuation errors or formatting issues. We have people for that!

-Justin McLaughlin

CEO, Acumen Medical Communications