We can develop new assays, or optimize existing biomarker assays for identification and monitoring of study subjects.
Our rapid results allow for rapid decision making at trial sites.
We provide project-level oversight during planning and execution, which includes recurring meetings, vendor management, and internal resource allotment.
We provide full-service quality and regulatory consulting to support development, implementation, and maintenance of quality management systems, design control support, design history file (DHF) activities and regulatory body inspections throughout the total product lifecycle.
Our lab manuals clearly outline sample collection, processing, and shipping requirements.
We produce Customized Test Requisition, Instructions for Use, and Test Result Reports.
Our IT systems track samples from storage through processing and resulting. Sample and assay data are stored securely and can be reformatted as needed.
Our growing sample and data biobank is available for data mining, product feasibility and validation, and assay development. Our biorepositories comply with the international ISO standard 20387, Biotechnology Biobanking Requirements to ensure all BMaD (Biological Material and/or associated Data) are handled in a way to enable reproducible research.
