PRA provides comprehensive data support with dedicated teams at all Phase I clinic locations. Our experts provide a full range of services including:
- Case Report Form design/review
- Rapid database setup, development and testing of validation check programming
- Data entry
- Data validation, review and query resolution
Our EDS data management teams use both paper and Electronic Data Capture (EDC) systems to produce high quality databases. PRA teams are able to work with multiple EDC systems according to client preference. We provide:
- Case Report Form design/review
- Rapid database setup, development and testing of validation check programming
- Data entry
- Data validation, review and query resolution
- Efficient integration of all external data sources into the study database, including format specification, test transfers and reconciliation against CRF data
- Delivery of a final study database in a client specified structure, including CDISC-SDTM compliant SAS® datasets (our default final structure)
PRA’s experienced biostatisticians, pharmacologists and medical writers in the United States and the Netherlands will transform your data into functional information. Our team will provide:
- Study design, protocol development, PK consultancy
- Randomization services, sample size calculations
- Statistical Analysis Plan development, including full Tables, Figures and Listings shells
- Interim study safety, dose escalation or PK reporting
- Production of Tables, Figures and Listings using industry standards of software systems like SAS® and WinNonlin® and adhering to internationally recognized coding standards such as CDISC
- Development of an Integrated Clinical Study Report (CSR), IDB/IMPD, statistical reports and Pharmacokinetics/Pharmacodynamics reports
Our experienced EDS data support team will support you throughout the EDS process and beyond.
