Clinical Trials Laboratory Services

Tailored Database: The LIS system at PBI is specifically designed for clinical trials and other research studies. This allows for the database to be customized for each study protocol. Reflex testing, alert values, delta checks, visit-specific blinding and exclusion criteria are some of the parameters that are tailored to sponsor specifications.

Customized Data Transfer: A Data Analyst is assigned to the project team to facilitate the data management plan for each study. Data file formats are customized to client requirements. PBI can program to particular data format specifications, or deliver data in any number of formats including current and emerging standards, such as HL7 and CDISC. Prior to the first data transfer, test data files are created and validated for accuracy and consistency. Quality assurance checks are performed on all data files prior to delivery. Transfer methods include electronic transfer via e-mail, dial-in, on CD/diskettes via courier, or by secure internet drop box

PBI takes pride in producing results of the highest quality and ensuring timely delivery of these results to sites via fax. Patient reports may be tailored to meet the needs of each study protocol. The project management team works with sponsors to implement study-unique requirements for reference ranges, reference range flagging, blinding, exclusion flagging, date formats, patient demographics, etc.

PBI provides Sample Analysis Plans at the beginning of setup for GLP studies. These plans include assay and reagent information, shipment dates and testing and reporting logistics.

Sample Analysis Reports are available upon completion of the study. These reports include assay details such as stability, study information, quality control data and report results.

• Translation of study requirements into a Central Laboratory Manual as an easy reference guide for sites
• Attendance at investigators' meeting for training of study sites
• Dedicated Project Coordinator for laboratory and site/sponsor for efficient query resolution, alert value notifications, and any site inquiries

PBI offers flexible services for customized central laboratory supplies based upon the needs of each protocol. Special emphasis is placed on user-friendliness of these materials, to ensure consistent, accurate handling of specimens at each site.

• Central Laboratory Manual (procedure manual) for each investigator
• A Central Laboratory Manual is prepared with detailed instructions for specimen collection, labeling, processing, and shipping. The protocol also includes easy-to-access information as appropriate such as reference ranges, alert values, turn around times and contact information for the specific PBI coordinator(s) responsible for the study.
• Pre-printed study-specific labels for samples
• Pre-printed, study-specific labels are designed for each study. Each subject is assigned a set of labels for all visits, with subject demographics captured at the first visit. This unique labeling system requires only minimal handwritten information from the site, as specimen labels already display the visit information, protocol number, specimen type and unique patient and accession number
• Visit-specific pre-packaged supplies or bulk supplies
• Visit specific kits are customized to meet the needs of each study and include all tubes, needles, and other items necessary for specimen collection. Bulk supplies can also be provided upon request. To ensure sites have current supplies, expiration dates are monitored throughout the study and kits are automatically recalled and replenished upon site request.
• Shipping supplies
• Shipping materials, including insulated containers and pre-printed airbills, are provided to the sites. These supplies are tailored to study requirements such as sample quantities, shipment temperatures, etc. Sites are provided with detailed instructions for proper shipment of specimens. All shipping supplies meet current IATA regulations.