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Services

Data Management

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

Data Management

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

Services

Bioanalysis

We analyze low volume samples from all biological matrices to determine PK/PD profiles and to support your biomarker research.

Bioequivalence testing

Fast and efficient PK based bioequivalence testing of topical generics.

Biostatistics

We offer a wide range of specialized biostatistical services to manage all aspects of your study from design to data analysis.
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