Data Management/eTrials

Our DM services – implemented in a company of its own

In 2007 we founded SocraMetrics in order to set up a completely new data management structure following internationally accepted standards – CDISC-compliant with SDTMIG standard and CDASH-based – embedded in a modern and completely validated IT system.

For details see SocraMetrics.

Data management at SocraMetrics includes

• CRF design and annotation
• Data Management Plan / Data Validation Plan
• Database design
• Data collection (double data entry / electronic data transfer)
• CRF tracking
• Data validation and automated edit checks
• Discrepancy management with pre-approved self-evident corrections (SECs) and data clarifications forms (DCFs)
• Medical and pharmaceutical coding (e.g. MedDRA, WHOART)
• Data extraction
• Database locking