BIOMETRICS: DATA MANAGEMENT & BIOSTATISTICS

Experienced statisticians versed in a variety of common and customized approaches to data collection, processing, and formal presentation for regulatory submissions. Services range from study design to reporting and cover the full spectrum of biometric services.

Services can be tailored or encompass broader biostatistical requirements:

• Electronic Data Capture
• Study Design
• Sample Sizing
• Protocol Writing and Review
• Randomization, including 24-Hour Central Randomization
• Database Design and Validation
• Data Quality Assurance and Data Rescue
• Table Production for Study Reports and other Vital Regulatory Submissions
• Encompassing Statistical Analysis, Reporting, Corroboration, & Review
• Overall Services to Assure Numerical

JANIX’s biometric services extend from Phase I—Phase IV studies with the capacity to utilize a variety of advanced bioinformatic technology platforms including Oracle Clinical™ and SAS© in conjunction with either our proven internal ICH compliant SOPs or those specified by sponsors.

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