In the role specimen storage plays in GLP preclinical studies, there is a simple answer; it is at the heart of pharmaceutical research and important to Food and Drug Administration approval for new drugs. However, that statement does need extensive qualification.To complete drug testing studies in preparation for human trials, the regulators insist that researchers retain the specimens for the record, which creates a demand for services that store materials securely and efficiently while complying with regulations.
Preclinical Trials Determine The Starting Points For Human Trials
Specimen storage makes preclinical testing possible in its current form, without it the only way to refer to the tests is through documentation, and that is not enough to satisfy the compliance demands of the regulators. The role of preclinical trials do not follow one predefined path, rather, they employ unique designs to generate data for specific medications before small-scale clinical testing on humans. This data is vital to determine viability and to reveal any hazards or reactions that might appear in the agent that is under investigation.
The regulations for good laboratory practice (GLP) and archiving facilities define the standards for storage of preclinical testing specimens. Under the research regimes dictated by agencies such as the FDA, who may request the stored samples to reconstruct the study as part of the regulatory audit process as defined for GLP, under CFR Part 58.1. It is the GLP that states you have to hold samples, should the FDA choose to audit the trial.
The Facilities That Preserve The Data From Preclinical Studies
The level of regulation and government guidance gives an excellent indication of the role of GLP specimen storage. Specifically, the FDA takes a keen interest and sets restrictive guidelines on storage, packaging materials, and seals for sample storage to prevent contamination and degradation.
The diverse types of delicate samples require extreme care to avoid inadvertently invalidating results. The outcomes of preclinical trials determine viability for potentially life-saving medicines, which might otherwise elude the medical community if studies fail due to inadequate procedures and compliance.
The Role Of The Services That Provide The Facilities For Specimen Storage
Contracting with laboratories that specialize in preclinical testing is an efficient way that sponsors can ensure that trials are successful. Specialized preclinical histology, pathology, and archiving services gain vast quantities of knowledge through years of service.
The client's capacity to store specimens might be limited while the research demands that they remain available for extended periods; contractors have the facilities to handle the volume. Service providers also invest in the security and safety features to delivering the end product safely, which include facilities that have security against illegal entry and fire suppression.
The Specimen Storage Facilities Of HSRL
Histo-Scientific Research Laboratories, Inc. (HSRL) provides state-of-the-art specimen storage for preclinical studies. We have ambient, refrigerated and frozen storage space that has the latest in industrial security and fire suppression. Other services include temperature controlled shipping, certified destruction, and worldwide shipping logistics. Contact us to find out how specimen storage by HSRL will assist in making your next preclinical trial a success.