Clinical Data Quality

High quality clinical data - usually defined by quality criteria prior to the start of the clinical trial - is crucial to judge and rely on the outcomes of clinical trials. Both are important for sponsors and regulators alike.

To improve and maintain data quality toclinco can offer all of the following services:

  • Functionality testing of eCRF prior to the start of the study or after system updates in accordance with clinical trial protocol objectives
  • Plausibility and usefulness of automatic / eCRF system-induced queries
  • Feasibility checks of clinical trial concept in a routine clinical setting
  • Early systematic central monitoring - via eCRF tool and/or blinded tabulated data exports - to identify systematic errors in data collection system, site-specific misunderstandings, false or arksome automatic queries, inhomogeneity of data collection procedures across sites, differential criteria for diagnosis across sites, differing national specific procedures or attitudes, ...
  • Systematic presentation of individual data by studied variables in pivot tables - visualisation of such variables in pivot diagrams
  • Interactions with operational study teams (e.g. monitor, study manager, safety manager) or direct queries to study site personnel  - timely follow-up of responses and introduction of corrective actions
  • Early detection of potential safety problems of clinical trial or close follow-up of identified safety problems