Case Studies
Late-clinical stage biotechnology company
A pre-commercial biotechnology company (Client) wanted to establish a clinical laboratory to screen and monitor donors sourced samples. This decision is based primarily on the high cost of using third-party laboratories.
Scope
The design of a clinical laboratory involves addressing key issues including but not limited to:
- Legal, regulatory, and liability including risk management and quality systems
- Specimen types and volumes as well as type and volume of tests to assure safety of donated SRM
- Testing methodology, instrumentation, equipment, and supplies needed to achieve this safety
- Process flow, utilities, and physical layout to achieve a high level of efficiency in achieving this safety
- Process flow, utilities, and physical layout to achieve a high level of efficiency in achieving this safety
- Administrative oversight and personnel training to assure quality service at low cost
Project Goals
We recommend that LabsHire provide support in all areas listed above with the goal of achieving:
- Regulatory compliance to federal, state, and local codes and regulations
- Donor and personnel safety throughout the entire process of screening and donation
- High quality services to the donor centers to assure accurate, precise, and timely reporting of testing results
- A cost structure that justifies the establishment of the laboratory
To achieve these goals, LabsHire consultants provided:
- helping the development of a quality system including policies, procedures, guidelines, monitors, forms, and reports that establish and maintain compliance
- of the endeavor by helping replace separate projects with a unified set of tasks required to stand up the lab
- by helping develop a unified set of requirements based on projected types and numbers of specimens as well as types and numbers of testing methodologies
- through helping in choosing instrumentation, projecting support equipment needed, designing workflow, drawing up process related layout of the laboratory, support development of documentation, and establishing staffing appropriate to the work intended under the unified set of requirements to comply with all regulatory requirements
Conclusion
By providing the above set of services, LabsHire helped the client avoid major problems and helped them to achieve their goals.
- testing for the recipients of therapy
- service to the donor centers and their donors
- value in moving from third party laboratory support to a Client run facility
