DATA MANAGEMENT

WHAT WE DO

PERI’s Clinical Data Management team provides a vast knowledge and flexible approach to producing high quality data. Our team collaborates with the sponsor to simplify the data gathering process and ensure the collection, organization, and validation of data to support your clinical goals. PERI performs routine data reviews to ensure the delivery of meaningful and high-quality data leading to reliable trial results. PERI offers customized, consolidated, cost-effective solutions for your data needs.

Technology: PERI partners with an industry leading EDC, with fully integrated IWRS, and has full in-house EDC build capabilities. In-house build allows for quicker turnaround timelines on any updates for potential amendments. Our Data Management team has experience in multiple platforms.

Data Management Offerings:

• Data Management support from study start-up to study completion
• Case Report Forms (CRFs) designed in compliance with Clinical Data Interchange Standards Consortium (CDISC) standards, to include both paper and electronic design
• Database design, validation, testing and implementation
• Data validation, review and cleaning
• Ongoing review/performance of discrepancy management and issues applicable queries
• Reconciliation of serious adverse events
• Medical coding using standardized dictionaries
• Collaboration with the study team to ensure clean data
• Extensive experience and knowledge in multiple EDC systems
• Integration of data from external sources
• Comprehensive management of data from third-party electronic data vendors
• Development, management, and maintenance of Data Management Plan and all affiliated documents
• Performance of database closure, data transfers and archival