Lab Services

Clinical Trial Support Services

  • Experienced in supporting long-term, multi-center clinical trials
  • Ability to support trials of virtually any size and duration for routine and specialty testing
  • Flexible enough to provide personal attention
  • Dedicated project management personnel to communicate with sponsors/sites
  • Rapid and customized data management support

Project Management

Effective communication with sponsors, central labs and sites is paramount in ensuring the successful outcome of a project; therefore, Pacific Biomarkers assigns an experienced Project Coordinator to each project team to meet the individual needs of a study. Project Coordinators translate study requirements into a Scope of Work that is used for database setup and laboratory testing logistics. During the trial, the Coordinator also serves as the primary contact and laboratory liaison with sites and/or central labs to efficiently resolve queries, report alert values and respond to inquiries.

Data Management

Tailored Database: The LIS system at Pacific Biomarkers 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. Pacific Biomarkers 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.

Result Reports

Pacific Biomarkers 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.

Sample Analysis Reports

Pacific Biomarkers 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.

Specialty Testing Services

  • Translation of study requirements into a Specialty Testing 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

Specialty Testing Supplies

Pacific Biomarkers offers flexible services for customized specialty testing 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.

  • Specialty Testing Manual (procedure manual) for each investigator
  • A Specialty Testing 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 Pacific Biomarkers 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.

Diagnostic Product Development

Pacific Biomarkers’ collaborations with diagnostic manufacturers allows Pacific Biomarkers to offer cutting edge technology and first access to many novel biomarkers.

  • Extensive experience in lipids, cardiovascular risk, diabetes, metabolic syndrome, osteoporosis, and cartilage metabolism.
  • Development and validation of reagents and new methods
  • Extensive experience in the support of FDA 510(k) submissions

Lab Certifications

Washington State Medical Test License (PDF)

CAP – College of American Pathologists (PDF)

CDC – Prevention Lipid Standardization Program (PDF)

DOH – New York State 2017 (PDF)

Pacific Biomarkers:
The Value of Expertise

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Pacific Biomarkers:
The Value of Science

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Pacific Biomarkers:
The Value of Client Team

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Strategic Alliances

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