Clinical Data Management

At Theorem Clinical Research, our team of global Clinical Data Management (CDM) experts are committed to upholding a standardized, process-driven approach. As a customer-focused operation, we feature a robust service portfolio and strive to ensure the highest quality results on every project. From database creation to database lock, our Clinical Data Management (CDM) professionals serve as an extension of your own team.

• Focused Expertise. CDM team leaders are healthcare professionals, hold degrees in biological sciences and/or a nursing, and have an average of approximately 12 years of experience in the data management field. They have experience in a multitude of therapeutic areas and have handled large and small global trials. Our data cleaning team members also average about seven years of experience.
• Comprehensive Solutions. Our complete service offering includes Case Report Form (CRF) design through final database transfer. Plus, we offer complete or partial Functional Service Provider (FSP) services. Our global staff uses our well-documented processes and Service Level Agreements (SLAs) to ensure timely deliverables. Whether you're interested in collecting data through traditional pen and paper or Electronic Data Capture (EDC), we can provide a solution to meet your needs. We're able to support standalone projects as well as fully integrated clinical programs.
• Quality. We have high standards when it comes to quality and we hold ourselves personally accountable for your success. That's why we have embedded quality checkpoints into our process from beginning to end.
• Global Approach. We have professionals in the United States, Canada, European Union and Asia Pacific Regions. No matter where you're located or where you're conducting your trial, all of our CDM experts around the world follow the same global Standard Operating Procedures (SOPs) to ensure consistency and quality.
• Robust System Portfolio. Our traditional system is powered through Oracle® Clinical, the industry standard. We also have a robust in-house EDC system portfolio that can be leveraged to fit your particular study, and multiple technology transfers allow our people to perform the work. We've performed 150+ EDC studies in the last 10 years in all phases and regions across many therapeutic areas.
• Performance Driven Processes. Our INTREPID EDC process streamlines database build, creates CDM and Monitoring role shifts, and ensures real-time review and freezing. In addition, our unique KickStart® Team manages your entire study database planning and build process. This group of experts works closely with you, external vendors and your Theorem Clinical Research Data Manager to define data requirements, design the eCRF, create the edit specifications, and manage the database build timelines to ensure a quality database is created on time, every time.