Study planning, clinical data monitoring, data management, and biostatistics are the foundation for success in the drug approval process. DP Clinical builds upon this foundation with flexible data management solutions. We have the ability to help sponsors design programs from inception, or we can work with organizations to strengthen programs already underway.
DP Clinical has significant data management experience across a number of Electronic Data Capture (EDC) platforms including Medidata Rave and Medrio (EDC, ePRO, eConsent, and RTSM) – giving sponsors more flexibility with study design based on cost, timelines, study size, and clinical strategy. DP Clinical is a Gold Member of the Clinical Data Interchange Standards Consortium (CDISC) and designs studies and analyzes results using these standards.
Our focus on quality has resulted in a very low query rate as audited by clients and external organizations.
DP Clinical’s data management services include:
- Case Report Form (eCRF) design, collaborating with the Clinical and Biostatistics teams
- Database design and implementation
- Data validation, review, cleaning, and query management
- Medical coding using MedDRA and WHO Drug
- Comprehensive management and reconciliation of data from third-party electronic data vendors
- EDC Help Desk support
- Data consolidation, migration, and conversion including CDISC SDTM
- Safety management and SAE reconciliation
