How Cisiv helped accelerate a Medical Diagnostic Validation study to obtain regulatory clearance

Cisiv partnered with a specialist CRO and a Medical Device Company (IVD Sponsor) to conduct an end-to-end process for clinical evaluation of an In Vitro Diagnostic (IVD) classed as a Rapid Diagnostic Test (RDT). This enabled the IVD Sponsor to obtain Emergency Use Authorization
(EUA) during the Covid19 pandemic in an exceptionally short time frame.

Cisiv’s capabilities and fit-for-purpose software proved to be an excellent solution for the efficient collection of of high quality data. Cisiv was able to design and implement the electronic platform in 15 working days, which enabled clinical validation data to be submitted rapidly during this
emergency.

Cisiv’s flexible and robust platform, along with its process, enables the delivery of clinical validation studies for In Vitro Diagnostics, Point-of-Care Diagnostics, Molecular Diagnostics, Genetic & Genotyping Testing.