Big Data is a buzzword.
Clinical studies are still driven by big ideas and the need for high quality, secure data.
Introducing DatStat for Electronic Data Capture
If you’re sure that your study idea will help patients, but frustrated by the limitations of resources and software, then you’re not alone. We worked with researchers at top facilities in the US, each of whom had study ideas bigger than their existing software could handle, to find a better way.
The result is DatStat for EDC, which opens up a world of possibilities beyond what paper-based methods or enterprise-wide software can accomplish. It’s built to handle complex patient forms or post-marketing surveillance (PMS) surveys with adherence to the latest FDA guidelines for electronic data capture and 21 CFR Part 11.
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Phase I, II, and III Trials
Secure eCRFs, plus…
Expert setup and configuration
- Electronic Case Report Forms
- Import and load existing data
- Participant randomization
- Reuse designs over and over
Unbelievable workflow tools
- Mixed-mode designs
- Participant screening and recruitment
- Task-based rules, timing, and status
- Conditional workflows
Phase I, II, III, IV, and V Trials
Patient Reported Outcomes, PMS surveys, and more
Award-winning software for surveys and forms
- Easy-to-use, menu-driven interface for survey design and eCRF changes
- Complex logic, validations, and scoring
- Real-time, online access to your data from any browser
- Pre-formatted downloads, with data dictionary, to SPSS, SAS, and more
Supports regulatory compliance and IRB requirements
- Access control based on user types and/or study locations
- Electronic signatures with time and date stamping
- Data change tracking (coming early 2013) for auditing
- Secure, redundant hosting included (self-hosting available)
RCT software for any phase
Electronic Data Capture software regularly provides workflow improvements to Phase II and Phase III studies. Now, DatStat for EDC brings these advantages to the complete spectrum of clinical and randomized controlled trials. Manage small batches of eCRFs in early phase trials scales or handle thousands of Patient Reported Outcome surveys for late-phase trials. DatStat for EDC scales up to capture data from study staff and participants located across town or around the globe.