What We Offer
Data Management
We are committed to our clients’ success and manage processes up front so that final data can be delivered shortly after database lock. Our data management services are backed by deep experience in providing a full range of services, across a variety of therapeutic areas and among many technologies — including electronic data capture, diaries and submissions. All services can be provided as part of a full-service solution or on a stand-alone basis.
Our Data Management services include:
- Case Report Form (CRF) design, electronic review and tracking
- CRF completion guidelines
- Database design and Trial Design Specification
- Electronic Data Capture (EDC) systems
- Database validation maintaining 21 Part 11 Requirements
- Data Management Plans
- Data Validation Plans
- Clinical coding with industry standards
- Double and Single data entry for paper and EDC systems
- Edit check development and programming
- Data validation and query resolution
- Electronic lab data transfers and review
- Datasets compliant with Clinical Data Interchange Standards Consortium (CDISC). Including Study Data Tabulation Model
- (SDTM) datasets, define.xml, Clinical Study Data Reviewer’s Guide
- Analysis-ready data sets creation through SAS, XML and other formats
- Electronic submission-ready data sets production
- Project data management
- Status reporting