Our services

 

Method Development

Developing your own With over a decade of in-vitro diagnostic assay development experience in the clinical laboratory field, we can bring to your laboratory a nearly turn-key solution with complete support from development through validation and implementation to comply with laboratory-developed test (LDT) status under CLIA, or Emergency Use Authorization (EUA) per Food Drug Administration (FDA) for COVID-19 assays.

Assay technologies we can develop on:

  • LC-MS/MS

  • HPLC-UV/Vis

  • GC-MS

  • RT-PCR

  • ELISA

Clinical Laboratory Practices & Processes Guidance

We provide guidance on improving processes in your laboratory, which leads to increased sample throughput, decreased cost, and increased quality output.

Our experience of preparing and successfully completing CLIA and CAP audits has prepared us to help you look for the common weak points auditors commonly identify.

Informatics Systems.

Informatics is one of the most common weak points in a laboratory, ranging from QC tracking matrices to even simple consumable inventory control. We can develop custom solutions for your needs, at a cost point far more competitive than the large software players.

Some of our products:

  • Clinical laboratory inventory system

    A lot, expiration date, and consumption trackers built-in to keep you in line with accreditation agency requirements and find savings in your consumables.

  • Quality control tracker

    Simple to use, low-cost alternative to proprietary software that helps you generate Levy-Jenny plots and utilize Westgard rules in your quality control scheme.

Specialized Advisory Services.

Whether you are starting a new laboratory or already own one and need advice on how to improve the performance of your team and processes we are here to help.

Or perhaps you need help with accreditation such as CLIA, CAP, or ISO15189 or 9001:2015, we are the experts on the matter.

Don’t hesitate to contact us, to help you achieve your goals.