All specimens provided by CBI are collected following the CBI Standard Operating Procedure developed using the highest procurement standards based on ISBER Best Practices and NCI standards. This insures dependable quality metrics are met for all samples delivered to a Sponsor. Our trained personnel ensure proper specimen collection, processing, deidentification, accurate data recording, storage and retrieval procedures to preserve sample viability and functionality for research projects.

One set of SOPs and procedures for all sites

The availability of high quality biological specimens is of utmost importance for life science research. Standardizing methods for collection, storage, retrieval and shipment of specimens across collection sites is essential to ensure the quality of the samples and enable consistent analysis of DNA, RNA and proteins. Standardisation of processes across all our Biospecimen Source Sites is a way to minimize errors in samples procurement, preparation and QC. It also is necessary for statistical procedure control and root cause analysis within required quality and tolerance limits.

Full chain of custody for consent, collection, shipment, storage and distribution

Establishing a chain of custody (COC) is essential to remove doubt regarding the identity and integrity of specimens to be analysed and allows the research project utilizing specimens to defend the findings. COC implements the process necessary for statistical procedure control and root cause analysis within required quality and tolerance limits. CBI creates a unique electronic version of COC for each project. The form is securely shared with Principal Investigators at Biospecimen Source Sites, Site Coordinators, Technical Project Managers (TMP) and Sponsor. All parties can follow COC in real time as it gets populated by all parties at different steps during the procurement process.

Two lines of control and verification for all processes

At the Biospecimen Source Site, the Principal Investigator and Site Coordinator work in parallel to ensure that no mistakes are made in sample handling including quantity, packaging, storage, labelling and data entry. At the sorting facility two TMP work in parallel to ensure accuracy for each measured parameters.

Tissue QC: histology diagnosis, percent of tumor nuclei and necrosis

For each FFPE block the following two independent evaluations (see below) are performed for the following parameters: Histology Description, Tumor Grade, Tumor Nuclei %, Necrosis %.

Two part verification by local site and US certified pathologist

A pathologist will evaluate H&E slides at the Biospecimen Source Site. This enables the PI to preselect those samples that meet the requirements of a given project. Then a second evaluation of the H&E slides will be made by an independant US certified Pathologist at the sorting facility. Two independent evaluations are thus used to select the samples for final submission to the Sponsor.

Chip electrophoresis analysis to verify DNA integrity (per request)

For some studies, usually involving analysis of DNA and RNA extracted from FFPE material, a DNA integrity test is performed to evaluate DNA and indirectly RNA quality. The implication is that if average size of DNA fragments in FFPE sample are the same as DNA from frozen tissue than the FFPE tissue is of good quality.

Cell quantity & viability (per request)

Frozen cell preparations can be checked for viable cell quantity at the sorting facility to verify that source site has delivered requested quantity and also to ensure that no damage occurred during dry ice shipment.

Specimen integrity, weight and volume control

All samples are visually examined by TPM at the sorting facility for size, volume, labeling, and other parameters to ensure proper collection, storage and shipment.

Error proof data entering and reporting system

All data is entered into the CBI secured database. Data is regularly backed up and maintained by dedicated IT personnel.

CBI Quality Guarantee

In the rare event that Sponsor receives specimens failing to meet QC standards as described in the SOW, CBI will replace all samples free of charge. Samples must be returned to CBI within 30 days of Sponsor’s initial receipt to take advantage of our CBI Quality Guarantee.