We provide data management services, ranging from defining the information to be collected to exporting data for statistical analysis, focussing on the essential of each project. We work to minimize the timing between the processes of data collection and data analysis, with a high standard of quality, always complying with the specificities of your goals.
Our data managers are members of the Society for Clinical Data Management (SCDM) and of the Clinical Data Interchange Standards Consortium (CDISC).
Our processes follow the good clinical data management practices.
Our Data Management services include:
- Clinical Study Protocol (support in data definition and data handling procedures);
- Case Report Form (CRF/eCRF) development and design;
- Data Management Plan;
- Database development and implementation;
- Database support documentation (annotated CRF, datasets specification/dictionary, data entry instructions manual);
- Data Validation Plan;
- Data entry (single/double; local/hybrid/remote);
- Data validation;
- Discrepancy management;
- External data management (e.g. laboratory data loading);
- Data coding according to MedDRA dictionary (e.g. adverse events) and ATC/DDD classification (medication);
- Quality Control;
- Database lock;
- Data transfer;
- Data Management Report;
- Exportation of datasets;
- Implementation of CDISC norms;
- Preparation of submissions to regulatory authorities (e.g. EMA; FDA).
Our programing services include:
- Development of custom solutions for electronic data collection (eDC);
- Development of custom solutions for clinical research management;
- Consulting in processes for development of software – analysis, design, implementation, tests and validation.