Our strong team of Data Managers designs, builds, and deploys quality clinical databases to meet timelines while ensuring that your clinical trial data is managed with precision and accuracy. Our Data Managers average over 15 years of experience, and play a key role in your trials. Data management services are available on a per-project or full-time equivalent (FTE) basis, according to your needs.
- Timely and Smart processes; ongoing QC, continual process evaluation and improvement
- Protocol Review and Planning
- DMP, DVP, UAT Plan, eCRF Data Entry Guidelines
- Database Build
- Protocol-specific functional database, reviewed and compared prior to “go-live”
- Average 4 – 6 weeks from final protocol to “go-live”
- External Vendor Data Reconciliation
- Draft Data Transfer Specification provided for reconciliation of test transfer and first live data transfer
- Data Management and Biostatistics collaborate throughout - timelines, database build, SAP development
Our extensive library of CRFs/eCRFs (Case Report Forms) expedites the database building process, while technology allows us to easily duplicate studies, and leverage CRFs from one study to the next. This results in cost effective data management, faster time to database go-live, a functioning and intuitive clinical database, expedited database lock, and ultimately, accurate and clean data.
Efficient eCRF Setup and Simple Technical Requirements
- Simple and flexible deployment of eCRFs in multiple languages
- Fully customizable user roles and query workflow
- Comprehensive and flexible reporting tool
- Fully compliant with FDA 21 CFR part 11
We use industry leading software packages designed for both electronic data capture (EDC) and paper-based data capture, which allow us to be fully involved in building clinical databases. In fact, the Data Manager who built the database is often the one who cleans the data, providing you with one point of contact for all data management activities.