3 Tips To Jump-Start Your IND Nonclinical Study Report Writing
Writing an IND or IND study reports can be a daunting process for companies, small and large. There are lots of moving parts and people that can make or break the process. In the past few years of writing these reports, I’ve found that the following tips can help any client and medical writer move towards a successful submission:
1) TOOLS and TRAINING
Tools are key. The right tools and training on regulatory writing can not only make the process more efficient but will also help make the documents and data look their best self. Participate in training for client-specific software used for writing and reviewing before the writing process begins. The following are examples of commonly used tools to acquaint yourself before you begin writing.
2) DEVELOP A PROCESS AND EDUCATE YOUR TEAM
Develop a KOM (Kickoff Meeting) with the client and medical writers and discuss the writing process and the individual contributor roles. Questions that everyone on the team should know the answer to before starting the process are…
How does the medical writing process work (from background prep, to writing and reviews, and to QC/QA?
What are the specific roles of each contributor, and how does this fit into the overall process?
3) HIRE AN EXPERIENCED REGULATORY PROGRAM MANAGER
Having an experienced program manager is one of the most important pillars of IND report writing. This person understands and bridges the medical writers with the SMEs, senior management, consultants, and outside CROs – all in a timely manner. This person understands the underlying regulatory pain points and has great interpersonal skills to help navigate the team through the ins and outs of report writing smoothly as a team.
Mahin Arastu
Medical Writer
