Drug Development 101: How to Build a Good Review Team, Tip #3

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

Role and Responsibilities

Save time and frustration by identifying and confirming who is reviewing (see Tip #1), at what stage they are reviewing and, most importantly, who is approving a document. This is especially applicable to the timing of external KOL contributions, which should start as early as possible in document development, and senior management review, which will vary considerably across clients. Early engagement of senior management and internal alignment of key elements (eg, objectives, endpoints for protocols, and key messages for CSRs and submission modules) across team members prior to document initiation is a mitigation strategy for avoiding costly delays and excessive last-minute substantive revisions.

Advice: Develop a reviewer matrix prior to document initiating and distribute to all reviewers for their approval. No one should be caught unawares of who is responsible for review and when their contributions will be expected.

-Justin McLaughlin

CEO, Acumen Medical Communications