Our capabilities go beyond standard data reporting. CRAB Data Management assures that studies meet statistical requirements by verifying subjects’ inclusion criteria, adherence to study guidelines for treatment administration, and evaluability for efficacy. We are experienced in staging and disease processes, as well as the review of adverse events. We identify incongruities not found by edit checks alone. Our availability to site staff encourages timely data entry and query resolution. Our communication with monitors, safety teams and others assures data issues are discovered promptly and resolved quickly.
CRAB Data Management staff has extensive expertise with protocol consistency checks, electronic data management (EDC) system review and use, image management, specimen tracking and case report form design. Our goal is to provide quality service and cost savings to our clients through our oncology focus. We provide careful attention to detail to meet sponsor goals.
Our approach is strongly compliant with the recently released FDA draft “Guidance for Industry Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring.” download guide