News & Resources

8 Ways CROs Support Regulatory Compliance

Discover the vital role of regulatory compliance in clinical investigations for diagnostics. Learn how adherence to regulations ensures patient safety, diagnostic efficacy, and market access, driving advancements in healthcare. Explore the challenges, benefits, and future perspectives of navigating regulatory compliance in the ever-evolving diagnostic landscape. Click here to unlock the key to safe, effective, and innovative diagnostics.

ColoPlex Biomarker Data Published in Journal of Clinical Oncology

Abstract. Background: Colorectal cancer (CRC) is the third most common cancer worldwide motivating national screening strategies utilizing fecal immunochemical tests (FIT). Blood-based biomarkers could be an alternative method to increase compliance in population-based screening programs for early detection of CRC. We aimed to identify new blood-based biomarkers that could be potential candidates for use in colorectal cancer screening.


The development and commercialization of medical devices, including diagnostics, require a significant investment of time, resources, and expertise. To navigate the complex regulatory approval process and bring a device to market, many medical device companies partner with contract research organizations (CROs). In this article, we will explore the role of CROs in the diagnostics industry, the benefits of working with a CRO, and the different services that CROs provide to help companies bring their diagnostic devices to market.