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:
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
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.
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.