Running a clinical trial involves countless critical decisions, and selecting the right central laboratory is one of the most vital choices you'll make. A central lab serves as the cornerstone of data consistency, quality, and compliance across multiple trial sites. Selecting the optimal central lab for your trial can significantly influence the trajectory and ultimate success of your study. As you embark on this selection process, let's explore the key factors that should guide your decision-making.
Expertise and Capabilities
Start by ensuring the lab offers comprehensive services tailored to your trial’s needs. For instance, some laboratories offer services such as custom assay development, biomarker discovery, or companion diagnostics. These capabilities can be invaluable for trials that require specialized testing or are exploring novel biomarkers. In addition, the laboratory’s experience in your specific therapeutic area is crucial, so ask for case studies or references to verify their experience. Equally important is the lab’s technical staff—make sure they have the qualifications to meet your trial’s unique needs.
Quality Control and Regulatory Compliance
Quality control and regulatory compliance are non-negotiable aspects of clinical trials. Verify that the lab holds necessary accreditations such as CLIA, CAP, and ISO and adheres to Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and other applicable standards. A robust quality management system is essential for ensuring the integrity and reliability of your trial data.
For a more comprehensive evaluation, request recent audit reports or conduct your own audit. Review standard operating procedures and documentation practices to ensure they meet required standards. A central lab with a strong track record of regulatory compliance can help navigate the complexity of clinical trial regulations, saving you time and resources in the long run.
Global Reach and Logistics
If your trial spans multiple countries or continents, the central lab’s global presence and logistics are incredibly important to ensure consistency in sample handling and testing across diverse geographical locations. Confirm they have a network of facilities and collection sites across relevant regions and robust processes for sample management, including collection, transport, and storage. The ability to maintain sample integrity across long distances is crucial for the validity of your trial results. Additionally, review their capabilities for producing and distributing sample collection kits to multiple sites. Robust logistics capabilities can significantly streamline the operational aspects of your trial.
Operational Efficiency
Operational efficiency is key to staying on schedule. Review the lab’s typical turnaround times for various tests and ask about the lab’s capacity to handle your expected sample volume. Also, check if the lab’s data systems integrate smoothly with your existing trial management platforms for efficient data flow. Insights into their project management approach could also be useful; clear communication protocols and regular updates on progress and potential issues can help you stay ahead of any challenges that may arise during your trial.
Innovation and Advanced Services
The technological capabilities of a central lab can provide a significant edge. Assess whether the lab has advanced equipment and demonstrates a commitment to innovation in its processes and technologies. For example, labs offering advanced technologies like digital pathology can improve the speed and precision of pathological assessments. Similarly, labs with robust bioinformatics capabilities are invaluable for trials requiring large-scale genomic or proteomic data analysis.
If your trial involves unique testing, assess the lab’s expertise in developing and validating custom assays. Services such as multiplex immunohistochemistry and in situ hybridization can reveal deeper insights into complex biological processes. Additionally, the ability to create and validate novel biomarkers can be transformative for trials exploring leading-edge therapeutic approaches.
A Thorough Evaluation is Key to Choosing the Right Central Lab
Carefully evaluating a lab’s expertise, technology, quality control, global reach, and operational efficiency is essential to selecting a central laboratory that not only meets the technical demands of your trial but also supports its success. By investing time in a comprehensive evaluation, you’ll secure a partner—not just a service provider—dedicated to ensuring your trial achieves its objectives.
Ready to elevate your clinical trial with cutting-edge lab services? Explore how GoPath labs can support your trial with advanced pathology service offerings and innovative testing solutions. Contact us today to learn more!
References
Kleppinger CF, Ball LK. Building quality in clinical trials with use of a quality systems approach. Clin Infect Dis.2010;51:S111-S116.
Bhatt A. Quality of clinical trials: A moving target. Perspect Clin Res. 2011;2(4):124-128.
Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11(1):1-6.
Expertise and Capabilities
Start by ensuring the lab offers comprehensive services tailored to your trial’s needs. For instance, some laboratories offer services such as custom assay development, biomarker discovery, or companion diagnostics. These capabilities can be invaluable for trials that require specialized testing or are exploring novel biomarkers. In addition, the laboratory’s experience in your specific therapeutic area is crucial, so ask for case studies or references to verify their experience. Equally important is the lab’s technical staff—make sure they have the qualifications to meet your trial’s unique needs.
Quality Control and Regulatory Compliance
Quality control and regulatory compliance are non-negotiable aspects of clinical trials. Verify that the lab holds necessary accreditations such as CLIA, CAP, and ISO and adheres to Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and other applicable standards. A robust quality management system is essential for ensuring the integrity and reliability of your trial data.
For a more comprehensive evaluation, request recent audit reports or conduct your own audit. Review standard operating procedures and documentation practices to ensure they meet required standards. A central lab with a strong track record of regulatory compliance can help navigate the complexity of clinical trial regulations, saving you time and resources in the long run.
Global Reach and Logistics
If your trial spans multiple countries or continents, the central lab’s global presence and logistics are incredibly important to ensure consistency in sample handling and testing across diverse geographical locations. Confirm they have a network of facilities and collection sites across relevant regions and robust processes for sample management, including collection, transport, and storage. The ability to maintain sample integrity across long distances is crucial for the validity of your trial results. Additionally, review their capabilities for producing and distributing sample collection kits to multiple sites. Robust logistics capabilities can significantly streamline the operational aspects of your trial.
Operational Efficiency
Operational efficiency is key to staying on schedule. Review the lab’s typical turnaround times for various tests and ask about the lab’s capacity to handle your expected sample volume. Also, check if the lab’s data systems integrate smoothly with your existing trial management platforms for efficient data flow. Insights into their project management approach could also be useful; clear communication protocols and regular updates on progress and potential issues can help you stay ahead of any challenges that may arise during your trial.
Innovation and Advanced Services
The technological capabilities of a central lab can provide a significant edge. Assess whether the lab has advanced equipment and demonstrates a commitment to innovation in its processes and technologies. For example, labs offering advanced technologies like digital pathology can improve the speed and precision of pathological assessments. Similarly, labs with robust bioinformatics capabilities are invaluable for trials requiring large-scale genomic or proteomic data analysis.
If your trial involves unique testing, assess the lab’s expertise in developing and validating custom assays. Services such as multiplex immunohistochemistry and in situ hybridization can reveal deeper insights into complex biological processes. Additionally, the ability to create and validate novel biomarkers can be transformative for trials exploring leading-edge therapeutic approaches.
A Thorough Evaluation is Key to Choosing the Right Central Lab
Carefully evaluating a lab’s expertise, technology, quality control, global reach, and operational efficiency is essential to selecting a central laboratory that not only meets the technical demands of your trial but also supports its success. By investing time in a comprehensive evaluation, you’ll secure a partner—not just a service provider—dedicated to ensuring your trial achieves its objectives.
Ready to elevate your clinical trial with cutting-edge lab services? Explore how GoPath labs can support your trial with advanced pathology service offerings and innovative testing solutions. Contact us today to learn more!
References
Kleppinger CF, Ball LK. Building quality in clinical trials with use of a quality systems approach. Clin Infect Dis.2010;51:S111-S116.
Bhatt A. Quality of clinical trials: A moving target. Perspect Clin Res. 2011;2(4):124-128.
Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11(1):1-6.