DATA MANAGEMENT AND STATISTICS

MedPass has full biometrics capabilities including data management and biostatistics. MedPass International offers flexible data management solutions adapted to the specific needs of the trial and the client.

From small feasibility studies to rigorous pre-market trials and post-market registries, we deliver the data collection and management solutions that match your needs and your budget. Databases are programmed in Oracle using Capture System applications software that is fully compliant with 21 CFR part 11.

The system allows for both paper-based and electronic CRFs.
MedPass biostatisticians are highly experienced in medical device trials and have the expertise to prepare Statistical Analysis Plans and statistical reports for regulatory submissions.

MedPass International Biometrics department is a member of the SfdS (French Society of Statistics) and of the DMB (Biomedical Data Management).

Data Management

Paper-based and/or EDC Database Development
Case Report Form Design
Database documentation
Database Validation, Edit Checks and Self Evident Corrections
Data Cleaning and Query Management
Medical Coding (MeDRA and WHODrug)
SAE reconciliation
Database Transfers (required format)

Statistics

Study Design Development
Sample Size Calculations
Protocol Statistics
Statistical Analysis Plans
DSMB meetings, preparation and attendance
Statistical Reports
Communication Support (Articles, Abstracts, Posters)