Biometrics

Our biometrics professionals have an average of nine years of experience and a comprehensive scope of therapeutic expertise. It’s that level of knowledge that enables Theorem Clinical Research statistical programmers and biostatisticians to quickly extract, analyze and interpret the most pertinent clinical trial information and pass it along to our team of professional medical writers. Biometrics staff operates as part of the project team from the beginning, working with you to determine the endpoints to analyze, as well as statistical procedures, evaluation criteria, patient subsets and data display formats. Using our secure clinical trial portal, TrialShare, you’ll have access to biometric data on demand — without compromising the blinded nature of the study. Biometric services are available as part of an integrated development program or in a Functional Service Provider (FSP) relationship.

Biometrics Services

• Integrated or FSP
• Protocol Development
• Analysis Plan Development
• Data Analysis
• Reporting
• CDISC Standardization and Submission
• Data Monitoring
• Committee Support
• Safety Surveillance and Pharmacovigilance
• Clinical Quality Assurance