Data Management and Statistics

The Data Management department of GCP-Service covers every aspect of Data Management and Statistics, e.g. CRF design, data entry, database design, data validation, statistics and consultation.

Data integrity is beside welfare of study subjects the most important objective of Good Clinical Practice in clinical research. Our highly skilled and educated Data Management staff know their responsibility and takes care of providing an excellent data quality in an innovative and cost effective way. Our systems, SOPs, and personnel are equipped to manage paper based data capture as well electronic data capture EDC).

Supported by our leading-edge data management systems and integrated SOPs, our CDM staff can fulfill unique project requirements, such as:

  • Quick database set-up
  • Sponsor-defined CRF and DCF management rules
  • Customized query wording for clarity and conciseness
  • Accelerated query management
  • Unscheduled data reviews
  • Study timeline changes
  • Changes to Protocol, CRF Template and project specifications

Our flexibility in accommodating changes to project specifications is paralleled with a complete audit trail; while maintaining quality of study data and adhering to expected study timelines.

Our EDC system provides the following features and benefits:

  • Timely and rapid data acquisition and reporting
  • Integrated data check for completeness and plausibility
  • Integrated query management
  • Standardized documentation of adverse events
  • Individually configurable roles and authorizations
  • Simple and safe to use thanks to our "next steps" philosophy
  • Monitoring optimized by integrated reporting
  • Optimized tools for study control
  • Automatic acquisition of measured data, using pulmonary function analyzers offered by our partners
  • Effective Quality Risk Management according to ICHQ9
  • Data output in any desired format
  • Compliance with the requirements of the FDA (21 CRF Part 11 Electronic Records and Electronic Signatures) and GAMP

Beside our Data Management services we like to support you with planning and conducting the biometrical or statistical part of your projects including but not limited to:

  • Sample Size calculation
  • Preparation of statistical plan, clinical data management plan, data validation plan ect.
  • Preparation of final statistical report