The Biometrics team at MEDISCIS will prove to be an excellent resource to your study specifications with its ability to provide a complete range of services, including data management, data analysis and reporting. The flexible nature of our biometrics process allows us to effectively answer your requests, while ensuring the production of a study database and statistical appendices according to the highest quality standards. Moreover, team members are well prepared to handle the challenges and surprises of clinical trial data management (timeline changes, unusual database formats, data not delivered “per protocol,” unexpected results, etc.).
CAPABILITIES
Data Management
- Case Report Form design
- Database design and study set-up (MEDISCIS standard, Sponsor standard, CDISC)
- Data validation plan and documentation
- Double data entry (independent with audit trail)
- Data entry cleaning
- Data validation
- Query management (editing, resolution, & tracking)
- Adverse Event, medical and surgical history, previous and concomitant treatments coding (MedDRA®, WHODRUG®, Sponsor Dictionaries)
- Database updating (audit trail)
- Data management report
- Blind Review meeting
- Database lock-up
- Data transfer (SAS®, ASCII, etc.)
- Database audit
- Database archiving
