Data Management

The data management department at ClinResearch is a service provider to clinical project managers, CRAs, and biostatisticians, delivering top quality data on-time, within budget and helping to avoid delays in the clinical research process.

Database Development

Our Oracle-based data management system enables rapid and flexible data entry screen building, double data entry, coding/autoencoding, checks for completeness and consistency of data, query generation and query tracking. Tracking of CRFs, patient status, investigator fees and medication is also enabled. The system includes all industry standard coding systems including MedDRA, as well as client-specific dictionaries. An audit trail captures all changes in the database.

Data Entry

Data entry is conducted as double data entry by two independent data entry clerks. First and second data entry are compared, inconsistencies checked by the data manager responsible, and corrected if necessary. Proof-reading of a sample of CRFs serves as additional quality control measure.

Data Coding

Data coding is always conducted by our physicians who are experts in ICD, Costart, WHO ART, WHO DRL and MedDRA and experienced in handling client-specific dictionaries.

Query Generation and Tracking

Data queries are generated automatically by database retrievals according to a data validation plan. Futile queries are deleted by our physicians who perform a visual check of CRFs against automatically generated queries. Queries are prepared immediately after receipt of CRFs in order to speed up the process of data cleaning.

Other Services

data validation plans
continuous preparation of study status reports
tracking of investigator fees and study medication
programming and maintenance of safety databases
central randomisation
clean file meetings and clean file reports