Successful Clinical Trials Hinge on Sample Integrity. Who’s Taking Care of Yours?
Biological specimen management is one of the most critical components of clinical trial design and is embodied by a complex network of handling, processing, and testing. Every point of contact represents a new chance for errors or corruption to be introduced to the extremely valuable, finite sample material. For over 14 years and through over 1,200 clinical trials Cancer Genetics has offered value-driven, integrated biorepository and sample management solutions to our biopharma clients. CGI has invested significant resources to become one of only seven commercially accredited College of American Pathologists (CAP) and Biorepository Accreditation Program (BAP) biorepositories in the U.S. (N.C. CAP Accreditation #8033768 AU-ID: 1636028).
Our molecular extraction laboratory and storage facility are fully incorporated into our 28,000 ft² Clinical Laboratory Improvement Amendment (CLIA) certified genomics center located in Research Triangle Park, North Carolina. The biorepository includes -80°C, -20°C, 4°C, ambient, and liquid nitrogen storage conditions and has a capacity of over 3 million samples. We store sample types, including but not limited to: whole blood, plasma, serum, saliva, urine, frozen tissue, and formalin-fixed, paraffin-embedded tissues. CGI provides DNA and RNA extraction services for these and other specimen types, and we routinely develop custom extraction methodologies.
Biosample managers have to be prepared to address the unexpected and every region has its own large scale weather events. Here in the U.S. Southeast it’s tropical storms. The biorepository is continuously monitored (24/7/365) and logged for temperature and humidity conditions. Our disaster recovery and business continuity plan includes three back-up generators on site. Sample chain-of custody and full traceability is maintained through our 21 Code of Federal Regulations Part 11 compliant laboratory information management system (LIMS). The repository is secure card-access only and equipped with motion-activated recording cameras.
CGI provides end to end biorepository service, including reconciliation of inbound shipments, provision of sample manifests and database pulls, sample destructions and issuance of destruction certificates, and outbound shipment preparation/management. All outbound shipments are prepared and executed by International Air Transport Association (IATA)-trained personnel. CGI’s biorepository operations are supported by experienced project management, QC/QA, and data management teams. We adhere to Good Clinical Laboratory Practice (GCLP) and CLIA quality measures, with more than 400 Standard Operating Procedures in place. Over 50 client and regulatory audits have been performed on our facility resulting in no significant findings. CGI also operates a Continuous Laboratory Improvement Program, which tracks quality metrics on a quarterly basis and is overseen by our Medical Director.
Since CGI’s acquisition of Gentris Corporation, we have been actively engaging with key biopharma customers, about developing a preferred partner program for biorepository services. We believe that collaborations such as these further enhance the efficiency and value of our sample management solutions. Recognizing that every sample represents a patient, and that every sample can advance medicine has driven our dedication to quality systems and processes. Because clinical specimens are such valuable assets, we take the utmost care to preserve their integrity. Partnering with CGI will ensure the integrity, availability and strategic use of samples, and will help accelerate clinical programs.