GenWay Clinical Laboratory is a San Diego based CAP accredited CLIA facility specializing in Hematology and Chemistry testing.

GenWay’s Clinical Lab Director has more than twenty years of experience in both medical research and practicing medicine. GenWay was established in 1998 with a focus on assay and reagent development; therefore we have the ability to customize and develop assays specific to your clinical trial needs.

Custom Service Experts

• GenWay has extensive experience producing antibodies, protein standards, and assays for clinical applications;
• GenWay has the assay development knowledge to take new biomarkers, develop, optimize and validate a kit in a clinical setting to meet any need that are currently unavailable through GenWay’s catalog or via other organizations.

How it works:

First, a project manager will be assigned to review study protocols and specifications. GenWay’s Project Manager will determine project price proposal for laboratory/validation services. The project manager will present proposal and address all concerns with the study sponsor.

In addition the project manager will

1. Provide primary communication after the study begins
2. Develop customized requisition form to capture study specific information
3. Develop customized validation and verification plans
4. Design instruction manual detailing laboratory testing, requisitioning, packaging, transport and reporting procedures specific to study’s need
5. Develop visit-specific packaging, special reporting and design flagging criteria
6. Serve as primary liaison between study sponsor and GenWay’s Clinical Team
7. Determine sponsor’s data management needs regarding format and frequency of data transfer
8. Serve as primary liaison between study sponsor and LIS team

Logistics

1. GenWay Clinical Laboratory has an ever expanding network of over a hundred collaborating blood draw centers.
2. GenWay will design visit specific packaging that will be provided to the patient prior to visiting a lab location.
3. Each package will contain specific sample collection materials including transfer tubes, a detailed description of study protocol, a customized requisition form, customer service information, pre printed FedEx airbills, and a clinical shipping pack.
4. Genway has the ability for lab locations to be prestocked with bulk quantities of study supplies if localized centers better suit the study sponsor
5. Clinical Investigator Manual will be customized for the specific study parameters and will contain detailed instructions regarding specimen collection, preparation, transport, normal ranges and alert values.

Reporting Metrics

1. GenWay’s LIS team has the experience and knowledge for custom interface development. The IT development includes formal validation per electronic interface.
2. Datasets can be transferred incrementally on a weekly basis or cumulatively as defined by the customer. Files can be sent electronically (AES 256 bit encryption) or via diskette or CD-ROM media format.

Quality Assurance

1. GenWay is committed to providing laboratory testing services that meets your every need taking pride in producing high quality work, with the unit being personally reviewed by the CEO & President.
2. GenWay Clinical Laboratory has been awarded an accreditation by the College of American Pathologists (CAP) based upon an onsite inspection. This stringent inspection program is designed to specifically ensure the highest standard of care for all laboratory patients.
3. Proficiency Testing Program – GenWay routinely takes part in CAP’s Proficiency Testing Program
4. IT QA – GenWay’s LIS Director routinely audits all computerized systems and programs that are associated with Clinical Trials or Clinical Testing