B/DM

Data Management & Biostatistics

Data management

Medelis uses the latest technologies for electronic data capture, management and communications. Of course we can also use paper-based data collection when appropriate. Our services include:

• Case report form design
• Database design and creation
• Data entry
• Data validation
• Medical coding of adverse events and medical histories
• Database lock
• Data transfer

Biostatistics analysis and reporting

Medelis provides a complete array of biostatistics analysis and reporting, including:

• Sample size calculations
• Randomization schemes
• Study design & protocol development
• Statistical analysis plans
• Statistical programming using SAS
• Data conversion
• Statistical tables and data listing for clinical study reports (CSRs)
• Statistical reports
• Statistical consulting
• Statistical representation at FDA meetings