Data Management

We provide GCP-compliant comprehensive data management services specifically
tailored to your clinical and preclinical studies.

 

 

 

We manage data from various sources (e.g. clinical data, laboratory data, medical device data) and provide an easy-to-use, fully validated Electronic Data Capture (EDC) system > for your clinical data. We assist with all your data management tasks in a clinical trial, from protocol development to study reporting.

Our Services

  • Development of Data Management Plan
  • CRF/eCRF design and validation
  • Electronic Data Capture (EDC) >
  • User account management and EDC training
  • Development of validated data interfaces (for various external data sources, e.g. saftety lab, PK, PD, Sensor data)
  • Medical coding (MedDRA, ATC/DDD)
  • Data Validation Plan (DVP, incl. edit checks, rules)
  • Data cleaning (according to DVP incl. query management)
  • Data Visualization >
  • Database release meeting
  • Data conversion and export (CDISC SDTM, define.xml, CDISC SEND)
  • Database lock
  • Data transfer
  • Data archiving

Contact Us

 

Tell us about your study!

Schedule a conversation with
our Data Management Experts
to learn which solution will be
best for your unique study.