At ACL Digital Life Sciences, our clinical data managers are well-experienced in hosting EDCs or providing vendor oversight. Our clinical data managers have years of experience in multiple therapeutic areas across all Phase I-IV studies. We are highly qualified in CDISC compliance and SME-level expertise to produce results with the speed and accuracy you need.
Clinical data management supports the conduct, management, and analysis of studies throughout the entire period of clinical research. CDM comprises legacy paper and contemporary electronic case report form designing, clinical trials database design and programming, data standards implementation, data acquisition, data integration into the clinical trials database, data review, validation, coding, and database finalization.
Clinical Data Management Services
- Development of CDISC-complaint Case Report Form (CRF)
- CRF Annotation and Review
- Database Design, Build and Validation including UAT
- Electronic Trial Management support
- Data Validation Specifications
- Edit Checks programming and testing
- Data Processing through double data entry
- Query Management
- Experience with multiple EDC solutions – Medidata RAVE, InForm, Veeva Vault, OpenClinica, Medrio and other in-house EDCs
- Experience with SAE reconciliation
- Experience with External Data reconciliation
- Experience with supporting Audits
- Data Management Plan (DMP) development
- Project Management, experience interacting with study teams and vendors
- Data Transfer Specs generation
- CDISC/SDTM compliant deliverables including CDASH
- Experience with TMF and other documentation compliance