Pharma and biotech organisations outsourcing to CROs, face risks if sample management is inadequate. We consolidate best practices, risk mitigation strategies, and a compliance checklist with audit timelines to ensure regulatory adherence and research integrity
A comprehensive sample management policy is not merely a regulatory obligation; it is a critical component of risk mitigation. Effective protocols ensure that unforeseen events, such as equipment failure, do not compromise research or sample integrity or regulatory non-compliance or result in significant financial and time-based losses.
Clinical Trial Samples: With average per-patient trial costs exceeding $120,000, these samples are irreplaceable. Implement redundancy through aliquoting and separate storage.
FFPE Blocks and Slides: Used in histology and biomarker studies; finite and irreplaceable. Require controlled temperature and humidity.
High-Risk or High-Value Samples: Rare tumor types, rare disease samples, high-containment pathogens, or ethically sensitive materials demand stringent handling.
Nucleic Acids (DNA, RNA, cDNA Libraries): Highly sensitive to degradation; maintain RNase-free conditions and -80°C storage.
Cell Banks: Track freeze–thaw cycles, passage numbers, and perform authentication checks (e.g., mycoplasma).
Pathogen Banks: Ensure compliance with biosafety level standards and robust tracking.
Drug Candidates: Maintain detailed records and secure storage for IP protection.
Proteins and Antibodies: Preserve stability and batch consistency to avoid costly errors.
Implement redundancy strategies (e.g., aliquoting, separate storage).
Use validated monitoring systems for temperature and humidity with alarms.
Maintain robust and secure documentation and chain-of-custody records.
Ensure disaster recovery and backup power systems are tested regularly.
Regularly review and update sample management policies.
Audit CRO compliance with contractual obligations and regulatory standards.
Invest in secure, validated storage and tracking systems.
Download the factsheet at this link or fill in the form to get the fact sheet and let us know you'd like more information.