Data Management is an integral component of ARIANNE’s global capabilities. We provide our clients with comprehensive data management plans prior to study initiation, along with on-going reporting.
We use Oracle™ software: Oracle Clinical database software, a validated clinical data management system, as well as AERS and Thesaurus Management.
We can deliver the database in a format that matches the sponsor’s requirements and systems. In order to achieve a worldwide consistency, we centralize design and control of each project-specific database under a lead data manager, supported by the company's global standard operating procedures (SOPs). The data management planning process emphasizes close communication with the sponsor through all phases of development and review of database specifications. Quality Control mechanisms are in place to monitor every major element of the data management process.
Quality Control is built into every step of ARIANNE's data management process to guarantee quality.
Data Management services include:
- CRF design
- CRF tracking
- Project timelines
- Data entry guidelines including protocol-specific guidance
- Database design
- Programming
- Data quality validation
- Query management
- Thesaurus coding/Lab data administration
- Study close-out/database lock
- Quality control and assurance (queries and data)
- Status reports (any format, including web-enabled secure access, when requested)