BIOMETRICS PRACTICE

Orbis Data Solutions Biometric practice provides comprehensive Clinical Data Management and Statistical consulting services for all phases of clinical development. Our clinical data management expertise leverages hundreds of consulting engagements to ensure the integrity of our client’s clinical data. Our biostatistics solutions include designing protocols, developing and implementing statistical methodologies and supporting regulatory submissions.

The Biometrics Practice provides consulting services in:

• Study design and protocol development
• Clinical development plans
• Endpoint selection and validation
• NDA statistical sections
• Statistical programming
• Extensive validation
• SAS programming
• Database design and setup
• Data input in any format
• Case report form (e-CRF & CRF) design
• Database lock
• Data validation
• Complete audit trail
• User and dataset security
• Customized status reporting, performance metrics