Start it off Right: The Importance of Building an IND from High-Quality Nonclinical Reports

Nonclinical reports are one of the most critical pieces for building an IND, but are often poorly written. Low quality nonclinical reports can significantly delay IND assembly and will likely result in queries from FDA reviewers. High quality, well-written nonclinical reports ensure that your application is reviewed in a timely manner and that supportive data and messaging is clearly conveyed to FDA reviewers.

When authoring nonclinical reports, it is important to remember the following:

• Context is key! The report should be more than just methods and data. Provide context as to WHY the study was performed and an interpretation of the results.
• All aspects of the report should be thoroughly reviewed for clarity and accuracy. Discrepancies, missing information, and aspects of the report that are unclear may be flagged by FDA reviewers.
• Ensure that the reports are standalone documents and do not reference information that FDA doesn't have (i.e. internal SOPs, alternative product names, reports that will not be submitted with the IND, etc.).
• Don’t automatically assume that third party vendors (even the big ones) will provide high-quality, IND-ready reports. Thoroughly review all vendor-written reports for context, clarity, and accuracy.
• The style of writing should be appropriate for an IND submission and differs from that of internal reports, journal articles, etc. Be sure to adhere to FDA and ICH guidelines for nonclinical report writing.
• Don’t delay! Finalize, QC, and approve nonclinical reports ASAP. Authoring IND sections from non-final source documents can result in inaccuracies, inconsistent messaging, and significant re-work, all of which can delay your IND.

Halloran can support your IND through our nonclinical report writing and/or review services. Let us put you on the path to a successful IND. Contact Us.