Data Management

Prism® is a hosted solution that can be utilized by your internal data management team, by an out-sourced data group or by Nextrials in-house Data Managers.  If your project needs data management expertise, Nextrials has experienced data managers who can play a lead or supporting role in database design, data cleanup and database lock activities.

Thesaurus Mapping

For your study, you can elect to perform all adverse event and concomitant medication mapping internally, out-source the responsibility to a CRO or have this function provided by Nextrials experienced thesaurus administrators. Whatever you decide, you can perform this role independently or in conjunction with Prism®.

Prism® can map adverse events and concomitant medications through its integration with dsNavigator. Adverse events are mapped to standard industry dictionaries like MedDRA. Concomitant medications are mapped to industry drug dictionaries like WHO Drug. Prism® can even accommodate your custom adverse event or drug dictionary. All coding results are maintained alongside your clinical data and accessible by the project team. For terms that must be mapped manually, this can be performed by your team or by Nextrials professionals.

Custom Report Programming

Sometimes Sponsors require complex reports to effectively track study progress or patient safety.  Nextrials has  a number of experienced programmers who can convert your ideas into concrete, validated reports.  Once programmed, these reports are hosted within Prism® and can be run at any time on real-time data.