OcTech (Consulting and Lab), is a boutique, one-stop shop for CRO services located in St. Paul, Minnesota. OcTech provides robust evidence development for regulatory submission and marketing of medical devices and IVD products. The company is made up of highly experienced medical professionals with backgrounds in data science, clinical research, clinical diagnostics, and regulatory consulting.

 

Since the pandemic began, OcTech has been pivotal in the design, execution, and submission of various rapid COVID-19 test products for FDA’s emergency use authorization. OcTech Lab, a CLIA-certified laboratory, has provided high complexity central lab testing support for many of these studies. In addition, the lab has the staffing and capabilities to perform IVD analytical validation studies. OcTech is unique among CROs in that it can provide diagnostic testing, central lab testing for clinical trials, and bench testing to support IVD analytical validation, all within one facility.

 

While the recent focus for many IVD manufacturers has been on COVID-19 products, OcTech has the track record to help bring other diagnostic products and medical devices to market.