Clinical Trial Solutions

Confidently navigate the drug clinical trial process with proven diagnostic solutions, including kit de-sign and distribution, sample management, data analytics, data management, quality and regulatory services. We have extensive experience preparing for and executing end-to-end solutions for prospective clinical trials and retrospective studies.

Our valued partners leverage our tests for various applications, including preclinical biomarker research, retrospective analysis, clinical study enrollment, treatment monitoring, and seamless commercial deployment coordination.

Kitting Solutions

Clinical Specimen Kitting - Biodesix offers kitting solutions for your clinical trials needs. We can assemble and provide all necessary materials in your custom sample kit, including manuals, labels, vessels, and instructions for use, as well as provide supply chain management for all components. We will also handle all shipping and logistics of the collection kits and samples, making the whole process easier for you.

• ~5800 ft² FDA registered GMP medical device manufacturing facility

Biorepository Services

Your samples will be stored safely and securely in our highly controlled onsite biorepository; compliant to internationally harmonized ISO 20387, CAP and industry accepted standards for biotechnology biobanking (CAP, ISBER).

Biospecimen Data Services & Data Management:

• LIMS – maintain data and sample integrity.
• Automation limits error-prone manual data entry
• Accelerated time from receipt to result
• Robust security and traceability

Our LIMS is designed to streamline laboratory operations, handling tasks from sample and test pairing to result capture and result reporting.

GMP: Good Manufacturing Practice
ISO: International Organization for Standardization
CAP: College of American Pathologists
ISBER: International Society for Biological and Environmental Repositories
LIMS: Laboratory Information Management System