We’re committed to providing mission critical support to sponsors and CROs focused on saving and improving lives.
The College of American Pathologists (CAP) offers a prestigious Laboratory Accreditation Program. Unlike most other accreditations with straightforward requirements, CAP’s accreditation process is dynamic, collaborative, and fosters continuous improvement. The accreditation process is so rigorous that the Centers for Medicare & Medicaid Services (CMS) granted it deeming authority, allowing CAP inspections in lieu of CMS inspections.
The Centers for Medicare & Medicaid Services (CMS) regulate all non-research laboratories in the United States through the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program ensures quality testing, and requires laboratories to be certified by their state and the CMS.
With outputs sourced from central or local laboratories often taking up more that 40% of data collected in clinical trials, any inefficiencies can have wide-ranging effects on timelines, deliverables, and reporting, all of which can significantly impact a sponsor’s bottom line.
As part of our focus to help our clients advance their drug development programs, we’ve investigated what works – and what doesn’t – in terms of laboratory services for clinical trials and how labs can help sponsors and sites work through these issues.
The need for new, agile players in the Central Laboratory space has never been more evident. As sites and labs operate around the clock to collect and conduct the analysis needed for clinical trials, accessing the required resources and capacity for new trials with your central lab partner can be challenging.
Omnia Diagnostics has the capacity and the project teams to help you scale up quickly to meet your corporate deadlines, lab manuals finalized, data integration set up, methods validated, and logistics sorted to get the job done.