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Company data manager services. We provide you with experienced pharma professionals to support you in data management. We act in senior roles to set up your data management process and environment, to plan activities, to supervise other service providers and to communicate with your partners and regulatory authorities.
Operative data management. We provide you with data management of single studies, including:
- CRF design and review
- Database design
- Data entry, remote data entry and electronic data capture
- Medical coding with MedDRA
- Data validation and discrepancy management
Compliance. Our data management processes and systems are continuosly successful in audits done in accordance with regulatory requirements (e.g. 21 CFR Part 11). |
