Optimizing Sample Logistics for Global Clinical Trials

Optimizing Sample Logistics for Global Clinical Trials

Executive Summary

Cenetron and a multinational pharmaceutical corporation engaged in a project to streamline sample logistics for global clinical trials. Cenetron’s tailored solutions prioritize reducing preanalyticalerrors through standardized protocols and advanced logistics, benefiting both large and small pharmaceutical entities. This collaboration ensures enhanced trial efficiency, maintained quality and compliance, and increased client satisfaction through efficient logistics and reliable sample management.

Cenetron’s specialized solutions significantly contribute to the success of multi-center global trials for pharmaceutical corporations of all sizes. Their approach fosters efficiency, compliance, and confidence in trial outcomes, offering essential support for the advancement of innovative therapies across diverse therapeutic areas.

Client Profile

A prominent, multinational pharmaceutical corporation with a diversified portfolio of therapeutic areas seeks to conduct a series of multi-center global clinical trials. Recognizing the complexities involved in managing sample logistics across various trial sites, the client requires comprehensive central laboratory sample management and logistics services.

Challenge

The pharmaceutical corporation faces the intricate challenge of coordinating and managing sample logistics for multi-center global clinical trials across diverse geographic locations and varying regulatory environments—a difficulty similarly faced by small-to-midsize pharmaceutical entities, who may not have the robust resources to address these challenges. Ensuring the integrity, timely transportation, and efficient processing of samples from multiple sites to central laboratories is crucial for the success of nearly all trials. 

The client approached Versiti Clinical Trial Services to execute testing for one sample set within a broad global clinical trial. Upon receiving the proposal, our team identified significant efficiencies and cost savings by further leveraging our central lab services. Instead of the client utilizing separate testing partners and conducting the data reconciliation internally, we proposed a send-out workflow to increase efficiencies in timing, shipping, project management and data reconciliation, thus easing the burden on the client.

Pre-Analytical Emphasis

Acknowledging the significance of pre-analytical quality in ensuring accurate trial data, Versiti tailors its strategy to mitigate pre-analytical errors. This includes implementing standardized collection protocols, advanced logistics to minimize errors in sample transportation, and training programs to ensure clarity in protocols across diverse trial sites. This solution offers clients the expertise and structured approach required to streamline sample logistics.

Error Control and Management

Versiti specializes in minimizing variability and controlling errors in sample logistics, particularly focusing on pre-analytical stages. By employing integrated systems and expertise, Versiti caters not only to large pharmaceutical corporations, but also offers scalable solutions adaptable to smaller entities. 

Our experts address concerns regarding pre-analytical errors by integrating industry research insights, aiming to optimize sample logistics for both large and small-to-midsize pharmaceutical companies. Highlighting the critical nature of these errors, which contribute significantly (46.0-68.2%) to total testing errors, Versiti implements strategies to reduce errors in sample collection, transportation and site-specific complexities. This standardized approach enhances the quality and reliability of trial data for smaller pharmaceutical firms.

Outcome

Versiti Clinical Trial Services was able to identify multiple inefficiencies in the primary proposal, which included the individual logistics, logistics fees, increased opportunity for error, need for FTE reconciliation, and ability to reduce project management and data fees. Versiti Clinical Trial Services reduced the number of samples being sent to individual labs from the original proposal, resulting in cost savings of more than $600,000 in shipping charges. Further, by implementing this new process, the sponsor quickly recognized the opportunity to reconcile FTEs down to 1. Cumulative data transfers and reconciliation project management fees were reduced by almost $90,000 through the use of strategic, centralized services and minimized data transfers. 

Enhanced Trial Operations: Efficient handling, centralized processing and reduced transit times contribute to improved trial operational efficiency. 

Maintained Quality and Compliance: Versiti ensures the highest standards of sample integrity, regulatory compliance and data quality, which are crucial for the success of multicenter global trials and provide smaller entities with the necessary support to uphold quality standards despite resource limitations. 

Client Satisfaction: The pharmaceutical industry, including small-to-midsize entities, benefits from streamlined logistics, cost-efficient services and reliable sample management, building confidence in trial outcomes and fostering long-term partnerships with Versiti Clinical Trial Services for continued success.

Conclusion

Versiti Clinical Trial Services’ tailored, central laboratory sample management and logistics solutions play a pivotal role in facilitating the success of multi-center global trials for both large pharmaceutical corporations and smaller-to-midsize entities. This collaborative approach ensures efficient, compliant and cost-effective sample logistics, reinforcing the organization’s pursuit of groundbreaking therapies across diverse therapeutic areas and trial phases, while simultaneously providing smaller entities with the expertise and support necessary for successful trial executions.

 
Clinical Trial Management
Versiti Clinical Trial Services provides end-to-end trial management services for the successful execution of clinical studies.
 
Diagnostic, Analytical, Laboratory, & Research Services
Versiti Clinical Trial Services provides central laboratory services, including sample testing, assay development, site management and more.
 
Quality & Regulatory Services
Versiti’s Quality and Regulatory services equip therapeutic developers with the expertise to navigate complex regulations and ensure compliance.