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Services

Electronic Data Capture (EDC)

We offer a fully validated online system to capture case report forms (CRFs).

Fully validated online system to capture case report forms (CRFs).

We provide you with easy-to-use, intuitive, fully validated, FDA 21CFR part 11-compliant Electronic Data Capture (EDC) system based on OpenClinica Enterprise ® Edition.

Our Services

  • Hosting of OpenClinica ® Enterprise Edition on our own servers
  • eCRF development based on study protocol (incl. validation)
  • CRF export for paper based data capture
  • Web based interface for data entry
  • User account management with various roles and tailored views/screens
  • Medical coding (ATC/DDD, MedDRA)
  • EDC user training (offline and online)
  • Data validation (edit checks and rules incl. validation)
  • Full audit trail

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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