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The Importance of Archiving Preclinical Histology Slides for FDA Audits


If you are exploring the resources available in support of preclinical histological testing, it is useful to understand how important archiving preclinical histology slides is in creating the context and environment in which it takes place.

The keyword for contract research organizations (CROs) is regulation. The regulatory oversight and standards and practices imposed on the CROs that conduct preclinical testing is a burden but necessary and manageable for professional scientific organizations, even as it demands exact terms for documentation. The need to archive specimen slides is part of the regimen that makes advances in pharmaceuticals possible, and it disciplines organizations to achieve it with a high level of safety throughout the process.

Regulatory Oversight And Accountability

The regulatory structure of the Good Laboratory Practices (GLP) dictates how laboratories submit data to regulators. The GLP also defines the protocols for archiving slides and data on which labs researchers base their conclusions. It is also very particular about how laboratories must store and log their archives of specimens and slides. Preclinical trials and histopathology are part of a system that relies on science to deliver accurate and trustworthy results. So naturally, there is a high burden of proof and a need for regulatory oversight to ensure compliance and to provide a foundation based on consistent standards.

Accountability To Clients

Researchers and sponsors depend on the CROs they employ to maintain valid studies by conforming to rigorous standards of practice that define the boundaries of a study. The preclinical histopathology subcontractor’s integrity must reside beyond dispute when the results are on the line. The results and the reputations of professionals at all levels depend on the results and transparency in testing. As the pharmaceutical agents that undergo preclinical testing will go forward to small-scale human trial, based on the data collected from preclinical research.

A Valuable Information Asset

Creating viable histology slides is an art form; to produce slides from specimens is a demanding task that involves highly skilled workers using complicated and expensive. Samples have value in the data they contain and a cost in the effort exerted to extract it. Operational considerations include temperature controls, fire suppression, security, delivery, and destruction. While slides have to remain in storage, they must insure against the loss of these valuable information resources.

The loss of specimens invalidates trial results, which has repercussions such as the additional cost or repeating the research at a considerable cost, or a chain of events that puts the organization’s future in doubt. Given archiving for indefinite periods, specimen slides are sources of information and discovery in future research. But only if labs keep them in conditions that preserve their informational value.

Archiving Preclinical Histology Slides To GLP Standards

All of this background information is important to appreciate the need to archive slides by precisely defined standards. When you choose a contract research organization, it should be one that has already met the FDA standards. Of all the services rendered by SCOs the underlying service delivered is compliance and quality assurance, with data retained throughout the process. Laboratories that focus on the functions and responsibilities of preclinical histopathology are the ones that will return the most consistent and reliable results.

Withstanding Scrutiny Means Transparency

The data that histology slides contain must deliver results accurately. The need for precise results to protect human subjects in later trials and avoiding hazards is the driving force in setting the standards for preclinical trials. The FDA mandate for rigorous record-keeping extends to the right to inspect for an extended period. Archiving the test results serves as a protection against future actions and provides the transparency confirming the standards of the studies.

HSRL Inc. is a dedicated contract research organization, experienced with FDA audits and an expert provider of slide archiving services. You can contact us to find out about making your next preclinical trial a success!

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