Clinical Trial Support & Testing

Confidently navigate the drug clinical trial process with proven solutions, including kit design/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. 

From Phase I to Phase III clinical trials, we provide fit-for-purpose solutions that accelerate the development process.

Our services include:

Screening/Enrollment Assays

We can develop new assays, or optimize existing biomarker assays for identification and monitoring of study subjects.

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Rapid Turnaround Testing

Our rapid results allow for rapid decision making at trial sites.

Project Management

We provide project-level oversight during planning and execution, which includes recurring meetings, vendor management, and internal resource allotment.

Regulatory & Quality Service

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 Regulatory team helps develop strategies to determine the optimal regulatory pathway to successfully navigate the submission process for market authorization and market entry opportunities in multiple geographies.

Lab Manual & Sample Collection Protocols

  • Our lab manuals clearly outline sample collection, processing, and shipping requirements. 

  • We produce Customized Test Requisition, Instructions for Use, and Test Result Reports.

Sample Collection Kit Development & Logistics

We provide all materials needed for sample collection and safe return shipment. 
Our kit release, replenishment, and tracking ensure a complete chain of custody for samples from site to storage.  

IT System Support & Data Management

Our IT systems track samples from storage through processing and resulting. Sample and assay data are stored securely and can be reformatted as needed.

Site Network

We utilize our extensive network of clinical trial sites to meet the needs of our biopharma partners.
We have several ongoing, prospective clinical studies in support of diagnostic tests on-market and in our pipeline.

Sample & Data Biobank for Retrospective Studies

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. 

Reach out if you would like to learn more about our proven clinical trial support and testing solutions!