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Clinical Trial Sample Analysis

Clinical Trial Sample Analysis

Robust Clinical Sample Testing Solutions for Phase 1–3 Studies

Southern Research provides comprehensive clinical trial sample analysis services, specializing in vaccine immunogenicity and efficacy studies, validated assay protocols, and rigorous sample management. Adhering to Good Clinical Laboratory Practice (GCLP) guidelines, our dedicated clinical trial sample analysis team ensures precise and timely tracking within both BSL2 and BSL3 environments, supporting trials including seasonal influenza/highly pathogenic avian influenza (HPAI), monkeypox (MPOX), vaccinia, Dengue, Zika and COVID-19. Our commitment to global partnerships during pandemic emergencies underscores our readiness to support both public and private sector clinical trials worldwide.

What Sets Us Apart:

BSL2 and BSL3 laboratory capabilities
Select agent handling expertise
Advanced molecular biology and cell-based assays
Actively maintained critical reagent repository including infectious agents
High-throughput sample testing screening
Customized assay development and validation expertise
GCLP audited and regulated facilities
Comprehensive support across clinical phases 1-3
Extensive experience with FDA, European, and Japanese regulatory agencies

BSL3 and Select Agent Expertise

Our specialized containment facilities enable secure handling and accurate testing of clinical trial samples involving BSL3 pathogens and select agents, ensuring compliance with all regulatory standards.

Assay Development and Validation

We offer tailored assay development and rigorous validation, employing flexible, robust high-throughput methodologies. Our expertise encompasses various biological matrices, novel endpoints, and gold-standard assays.

Comprehensive Sample Management

Our robust sample management system, powered by Benchling LIMS, covers international shipping, meticulous chain-of custody tracking, secure storage, long-term retention, and detailed reporting. We provide end-to-end solutions to optimize your clinical trial sample handling processes.

Advanced Data Management

Leveraging our Laboratory Information Management System (LIMS), we ensure seamless data integration, compatibility with client databases, and advanced informatics support to streamline your data management workflow.

Specialized Scientific Oversight

Our dedicated scientific teams, including experienced statisticians and specialized researchers in oncology and infectious disease research, provide expert study oversight to ensure high-quality results.

Custom Clinical Trial Kit Assembly

We offer customized clinical trial kit assembly, simplifying logistics and enhancing efficiency to meet specific trial requirements and timelines.

Quality Assurance Oversight

Our dedicated Quality Assurance team ensures rigorous compliance with regulatory standards, including GCLP guidelines. Through systematic auditing, meticulous documentation review, and continuous process improvement, we guarantee data integrity and reliability throughout your clinical trial.