Case Study

Remote Monitoring Solution Improves Compliance

Source: INC Research/inVentiv Health

One of the world’s largest pharmaceutical companies had instituted an obligation for its monitors to review clinical data within 15 calendar days of it being entered into the database, but through December 2011, compliance had been just 78%. The client came to inVentiv Health Clinical to assist with developing an appropriate solution to improve the compliance rate.

In January 2012, we recommended a centralized remote data review team to improve the efficiency and compliance of monitoring patient visit data.

  • We began with a Pilot program to establish a process and worksheet for communication among the centralized remote monitors and field monitors.
  • Based on the demand at each site, we recommended a team of 35 CRAs, all of whom had at least two years’ clinical and EDC (electronic data capture) experience to fill the role of remote monitors.
  • Within five business days we had recruited and placed the 35 CRAs. They were on-boarded and trained using the client’s SOPs and their assigned protocols within two weeks.