CRC Pharma LLC

Clinical Data Management

Clinical Data Management

We provide complete and comprehensive clinical data management solutions from study start through clinical database lock for all clinical study phases i.e. Phase I to Phase IV, with both for FSP Model as well as stand-alone projects. Our Clinical Data Management (CDM) team extends its best practices from across our existing capabilities of statistical software products and services.

We support this, by using best-in-class technology, with 21CFR compliant tools, to provide time based, reliable and reproducible results to our small and mid-size Pharmaceutical and Biotechnology companies across the globe.

Clinical programming services include statistical programming, summary and statistical reports for non-clinical and clinical studies, including:

• Project management
• On- site and off-site CDM services
• Data management plan (DMP) development
• Paper CRF/eCRF design and development
• Query tracking and query management
• Medical coding for medical history and adverse events (ADR/AE)
• Safety data management & reconciliation
• Laboratory data reconciliation
• Data export/transfer
• CRF completion guidelines
• CRF annotation & review
• Database build & design
• Data validation specifications
• Edit checks, programming & testing
• Data processing through double data entry