6 Easy Tips to Improve Your Nonclinical Study Report Writing
After years of research your drug candidate is ready for the clinic. But before this can happen, all of the supporting nonclinical data need to be documented into study reports, which will serve as the foundation of your IND application. Assembling a strong portfolio of study reports is critical; the challenge is how to do this efficiently without overtaxing your research team. An added challenge is that many junior scientists in smaller drug developers may never have participated in an IND before.
Here are few suggestions to help kick-start your nonclinical report writing:
Key Messages: Identify the writing team early and align on key messages before writing starts. Knowing the key messages for each report beforehand and how those fit into the overall story is crucial and may reduce weeks of revisions from a single report.
Content: Develop common introductory language that is applicable across study reports. Focus the conclusions on clear findings that support key messages and avoid over rationalization or speculation. Well-written study report text is readily transferable to IND nonclinical summary documents.
Document Management: Ensure an accessible and central document storage/management system is in place and that all reviewers know how it works. SharePoint or another review platform like PleaseReview are industry standard but having experienced support for these systems is essential.
Reviewer Matrices: Develop a roster of all nonclinical reports with logical study numbers, and then assign writers, document owners, and reviewers to each document. Having a clear understanding of who has the final say in content disputes helps for smooth development.
Templates: Although report organization will vary based on the type of study, a good set of eCTD compliant templates helps provide the writers with a framework for organizing content and ensures that formatting is consistent and clean.
Style Guide: Establishing your drug’s nomenclature conventions within a style guide allows for more consistent documents and reduces team comments and overall development time.
Study reports are the critical building block for your IND submission. Engaging those experienced with filing INDs, like nonclinical writers, project managers, and submission experts, will help ensure you don’t make those rookie mistakes that have ground many first submissions to a halt. With some early planning and processes in place, your team will be able to focus on your science and data interpretation.
Director of Nonclinical Writing
Acumen Medical Communications