As sponsors continue to restart paused studies, there will be a flurry of medical writing activities taking place to support IND submissions, investigator brochures, protocols, and other documents. Given that, below are tips to help improve the quality and efficiency in creating these documents.

7 Tips:

1. Organization and communication. Documents drafted by medical writers require close coordination with study team members (CMC, PharmDev, Tox, Clinical, Stats, QA/Reg, and others). Organization and a timeline for document drafting, review, and updates is key. Designate a project manager who will coordinate these activities with the team to ensure timelines are being met. Consider timelines for publication vendors and time to submit the document to the agency in your overall timelines.

2. Determine who will be the final decision maker on issues where there are multiple opinions and how these decisions will be made. Too many times comments within documents will lead to differences in opinion where a decision is required. Knowing who to go to for that final decision and making that clear to the team will ensure efficiency in the document finalization process.

3. Do not ask everyone to review the entire document. While it is great to be inclusive and ask for general review, be more strategic in the review process. Everyone is busy and limiting the team's review will yield better compliance to review timelines.

4. Consider the technology used for document review and how comments will be managed. While emailing documents and asking for track changes in Word are great for a few reviewers, it gets unwieldly if comments from 10 or more people will be coming for one writer to manage. Consider the online version of Word or other solutions such as PleaseReview for document collaboration.

5. Obtain general approval/agreement on a template. Multiple templates exist for a variety of documents and agreement on which template to use in advance will save everyone time in the end. A bad template will result in additional review time and a lower quality document.

6. Determine and document which style guide will be used for documents and references.

7. What is the QC process and who will ultimately review the document for QC and at what time-point will that happen? A QC that takes place too early can result in rework. A QC process that takes place too late could result in key experts providing basic grammar and wording feedback in addition to their scientific expertise.