CROS NT extends Medidata partnership

23-May-2017 - Last updated on 24-May-2017 at 14:50 GMT

ICH GCP E6(R2) guidelines outline a risk-based approach to clinical trial monitoring. (Image: iStock/liuzishan)

The extended partnership provides CROS NT customers access to Medidata’s electronic data capture (EDC) solution as well as its randomization and trial supply management system (RTSM).

Andrew MacGarvey, CEO of CROS NT, told Outsourcing-Pharma.com the company needs a number of systems in its portfolio to serve its customer’s various needs – “and the Medidata products form an important part of our offering,” he said.

As part of the extended relationship, CROS NT gains access to RaveX, the latest generation of Medidata's EDC system Medidata Rave, and Medidata Balance, a randomization and trial supply management (RTSM) system.

“RaveX is an ideal technology to support sponsors implementing a risk-based approach to clinical trials by improving the quality of data coming from sites,” MacGarvey said, noting the ICH GCP E6(R2) guidelines that come into effect this June.

“By adding RaveX to our portfolio of technologies, we are further equipped to help sponsors implement their risk-based clinical and data strategy,” he added.

Medidata has also trained and accredited the contract research organization’s (CRO) data management team.