CliniBiz assimilates the clinical trial model as a business by crafting subject enrollment procedures, operational workflows and quality management processes that oversee study startup, execution and closeout.

Our approach to performance results in more subjects enrolled, fewer dropouts and higher data quality.

Our Solutions Include:

• Study Project Setup, Vendor Selection and Oversight
• Study Site Selection and Startup
• Budget & CTA Negotiation
• Assist Sites with IRB Submissions
• Assist Sites with Regulatory Packages
• Developing eLearning / Remote Training for SIV
• eTMF and eReg Binder Management
• eCRF Design, Edit Checks and UAT
• Clinical Project Management
• Remote and Risk-Based Monitoring
• Modern Electronic Site Communications
• eConsenting and Subject Identity Verification
• Data Management and Queries
• Medical Monitoring, and Safety (INDSRs, MedWatch & SUSAR)
• Quality Assurance
• Payment Reconciliation