How to Prepare a Comprehensive GLP Preclinical Final Report That Accelerates Review and Funding

How to Prepare a Comprehensive GLP Preclinical Final Report That Accelerates Review and Funding 

Meeting deadlines and securing ongoing investment for your medical product hinges on the timely and efficient review of your GLP preclinical final report. With tight timelines and reviewers handling multiple studies simultaneously, crafting a report that is both thorough and easy to navigate is crucial for speeding up the regulatory and funding review process. 

With years of expertise in conducting preclinical studies and authoring GLP and non-GLP final reports, our subject matter experts at BioBoston Consulting share proven best practices to help you develop a winning preclinical study report. 

 

Understanding the Reviewer’s Role 

In this context, a reviewer can be anyone evaluating your preclinical data, including: 

• Regulatory agencies 

• Investors and due diligence teams 

• Grant committees 

• Preclinical consultants 

• Study directors and project managers 

Recognizing their perspective is key to tailoring your report for clarity and completeness. 

 

Crafting an Effective Executive Summary 

A well-written executive summary sets the stage for reviewers by: 

• Introducing the test article and its relevance 

• Explaining the rationale for the study 

• Summarizing the study objectives, methods, key findings, and conclusions succinctly 

This overview enables reviewers to quickly grasp the study’s scope and significance without wading through the entire document. 

 

Key Components of a GLP Preclinical Final Report 

Personnel and Qualifications 

Detail all individuals involved—from the study director to husbandry staff—along with their relevant credentials. Compliance with 21 CFR Part 58 mandates qualified personnel, assuring reviewers of the team’s expertise. 

Study Objectives 

List each specific objective exactly as stated in the protocol, avoiding summarization. For example:
“The objective was to evaluate safety via absence of adverse events, mortality under 5%, and no thrombus formation.” 

Enrollment and Animal Tracking 

Provide a clear enrollment table listing animal IDs, implant and explant dates, follow-up schedules, early mortalities, and termination dates. For chronic studies, note each animal’s duration on study. 

Test Article Details 

Describe your device or product comprehensively, including photographs. Even if detailed in the protocol, reiterating test article specifics improves clarity. 

Use, Disposition, and Characterization 

Include tables for lot numbers, manufacturing dates, implant details, and animal linkage. Attach sterility certificates, build records, expiration and stability data as required, with references to appendix locations. 

Animal Source and Background 

Document vendor information for healthy animals (USDA-approved), including contact details and animal history, confirming study validity. 

Detailed Methods 

Explain all procedural steps—implantation, monitoring, exams, pathology assessments, and observations. Note and justify any deviations from the protocol, referencing logged deviations. 

Results: The Core of Your Report 

Present all outcomes, including expected and unexpected findings, supported by tables and representative images. Summarize raw data clearly within the main report body to prevent reviewer frustration and delays. Highlight the impact of any amendments or deviations on data quality and animal welfare. 

Discussion and Conclusion 

Interpret the results thoroughly, especially when findings are complex or unexpected. Clearly confirm whether each objective was met, with complete sentence conclusions. For example:
“No adverse events were observed, fulfilling the safety objective.”
Avoid vague statements like “See results.” Include final conclusions from all contributing scientists. 

 

Pro Tips for Reviewer-Friendly Reports 

• Label all figures clearly with high-resolution images that effectively illustrate results. 

• Use tables wisely, ensuring they are easy to understand, prefaced by descriptive text, and summarized in complete sentences. 

• Attach comprehensive appendices with signed or verified documents such as the study protocol, amendments, deviations, clinical and histopathology reports, raw data tables, case report forms, and test article characterization. 

 

Partner with BioBoston Consulting for Preclinical Study Success 

Preparing a flawless GLP preclinical final report can make or break your regulatory approval and funding opportunities. If you are assessing your medical product’s readiness for preclinical or GLP testing—or if prior studies have prompted regulatory questions—our expert team at BioBoston Consulting is ready to help. 

With a track record of supporting over 100 regulatory submissions that were accepted with zero queries, we provide unmatched expertise in navigating preclinical study challenges and optimizing report quality. 

Contact BioBoston Consulting today to discuss your project and ensure your preclinical studies are set up for smooth regulatory review and investment success. Remember, the earlier you engage experts, the better your chances of a seamless path forward.