Introduction
We’re proud to share that our paper, “Standardization in Clinical Trials: Optimizing Biospecimen Collection, Preservation, and Export,” has been published in the International Journal of Research and Innovation in Applied Science (IJRIAS), Volume 10, Issue 11 (November 2025). The article was received on Nov 22, accepted on Nov 28, and published on Dec 18, 2025. This milestone underscores myOnsite Healthcare’s commitment to quality-by-design, patient safety, and data integrity across modern clinical trials.
Published Paper Details
- Paper Title: Standardization in Clinical Trials: Optimizing Biospecimen Collection, Preservation, and Export
- Authors: Dr. Hinal Panchal, Mr. Mayank Trivedi
- Journal: International Journal of Research and Innovation in Applied Science (ISSN: 2454-6194)
- Volume/Issue: Volume 10, Issue 11 (Nov 2025)
- Pages: 782–793
Abstract (Summary)
The review synthesizes evidence-based standards for the entire biospecimen lifecycle collection, preservation, storage, and international export and maps them to the 2025 ICH E6(R3) Good Clinical Practice update. It highlights how pre-analytical variables (timing, environment, handling), ISBER Best Practices and IATA shipping rules work together to protect sample integrity, improve reproducibility, and enable global collaboration.
Key Highlights
- Quality-by-Design under ICH E6(R3): Trials should identify Critical-to-Quality factors, apply risk-proportionate processes, and ensure comprehensive data governance (Audit trails, validated systems).
- Controlling Pre-Analytical Variables: The paper summarizes NCI/BPV insights and evidence-based procedures that reduce variability from cold ischemic time, fixation, freezing, and storage. (See the “Critical Pre-analytical Variables” graphic on p. 783.)
- Standardized Collection Workflow: Clear protocols for temporal controls, environmental controls, and documentation (chain of custody, timestamps, QC metrics). (Workflow diagram on p. 784.)
- ISBER Best Practices & QMS: Guidance for SOPs, personnel competency, QC panels, audits, and disaster preparedness; emphasizes real-time monitoring and redundant systems. (Management overview on pp. 785–786.)
- Optimal Storage Conditions: Clear temperature standards for snap-frozen tissue, plasma/serum, whole blood, extracted nucleic acids, with 24/7 monitoring/alerts. (Storage temperature table on p. 787.)
- Traceability & Compliance: Barcoding, location tracking, freeze-thaw tracking, and LIMS support for HIPAA/21 CFR Part 11/GDPR/ISO 20387 compliance.
- Export & Shipping: Practical classification and triple-packaging rules for UN3373 Category B materials, dry-ice declarations, and customs/permit considerations. (Regulatory framework diagram on p. 789.)
Closing Note
Congratulations to Dr. Hinal Panchal and Mr. Mayank Trivedi for leading this timely, practice-ready synthesis that supports sponsors, CROs, sites, and biorepositories in achieving consistent, auditable biospecimen quality.