Clinical Test Qualification

Clinical Test Validation & Launch

We provide turnkey solutions for CLIA/CAP/CLEP validation and accreditation of clinical tests, and launching in US market. With your clinical testing technology, our turnkey solution covers:

  • Strategy & consultation
  • Assay development
  • Clinical validation
  • CLIA/CAP qualification
  • Lab operations/testing
  • Clinical test sign-off
  • Lab space & instrument sharing
  • Sales & marketing support
  • Reimbursement billing support
  • International market expansion support

The major benefits of partnering with us include:

  • Cost-saving
    Take advantage of our well-established infrastructures. Up to 80% savings.
  • Quick launch
    Significantly shorten the time to launch your product in the US.
  • Excellence of operations
    Take advantage of our established QA, LIMS, LIS, and automation to achieve operational quality, efficiency, scalability, and compliance.
  • Access of expertise
    Have access to all the needed expertise, from consultation to implementation.
  • Better use of resources
    With a reliable partnership with Admera, you will be able to re-allocate your resources to innovation and remain technologically competitive.

Here is a case study

  • Scenario
    A US company has an innovative clinical testing technology addressing an unmet medical need, but they lack resources and expertise to turn this technology into a qualified clinical test and provide services to patients within an aggressive timeframe.
  • Solution
    The company investigated a few options and selected us to be their partner due to our cost-effectiveness and turnkey solution. With our established infrastructure and experience, we seamlessly worked with them to validate the clinical test, obtain CLIA approval, and set up a test delivery workflow from sample accession to test reporting, all within a few months.

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