Clinical Data Management and Biostatistics

Clinical Data Management

Ecron Acunova provides state-of-the-art data management of clinical studies with respect to both, procedures and equipment. The variety of services ranges from traditional paper-based workflow to modern remote data capture, all fully compliant with 21 CFR part 11 regulations. Detailed SOPs describe content, re¬sponsibilities as well as procedure and quality measures for all tasks.

Oracle Clinical was introduced in the company in the year 2000. Currently the organisation uses OPA 4.5 (Oracle Pharmaceutical Applications), encompassing Oracle Clinical 4.5, TMS 4.5 (Thesaurus Management System), and RDC (Remote Data Capture). Electronic CRF as well as paper CRF can be designed and derived directly within the system allowing conventional study conduct, purely electronic data management as well as hybrid solutions. SAS version 8.2 (Statistical Analysis System) is used for data export from Oracle Clinical to the statistical analysis and to the sponsor.

Biostatistics

Ecron Acunova provides continuous biometric advice during the study covering: statistical planning and sample size calculation, randomisation procedures, statistical analysis plan, statistical programming and analysis, interim analysis, valid statement (classification of patients into different populations for analysis), blinded review committee, SAS datasets according to sponsor’s specification, integration of data bases, electronic data transfer, statistical evaluation with SAS™, statistical report and summaries, meta-analysis.

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