Data Management
ClinTec International provides a full-service for Clinical Data Management and Biostatistics in Phase I - IV clinical studies, to the R&D organizations of Pharmaceutical and Biotech companies.
Our unique selling point is simply delivering on time and according to the agreed budget. We ensure high quality and performance through real ClinTec experts having many years of experience in different therapeutic areas, being supported by the appropriate systems and a perfect international working environment.
Our services in Data Management
- Data Management input to the clinical projects/studies
- CRF design
- Data Collection: Electronic Data Capture (EDC) or manual Data Entry from paper CRFs
- Data handling and data cleaning in our 21 CFR part 11 compliant Database Management System, according to ICH-GCP
- Coding of medical terms (Medications, Secondary Diagnoses and Adverse Events)
- Serious Adverse Event Reconciliation
- Transfer of high quality data for statistical analysis and submission to the regulatory authorities, according to CDISC or client specific data standards
- Data Management consulting/training for implementation of new systems, coding & dictionary management or creation of new Standard Operating Procedures (SOPs)
providing a helping hand in clinical research