StudyWorks
StudyWorks is an online portal which provides real-time access to data collected using the LogPad and StudyPad. With standard and custom data summaries and reports, it enables site personnel to manage compliance and enrollment, while helping sponsors stay on top of their global trial at all times.
Firsthand Knowledge
Study coordinators tell us the most valuable aspect of an ePRO solution is the ability to track and manage patient performance and diary compliance. Using StudyWorks, sites easily review data summaries each morning (or whenever they want) to monitor and evaluate patient symptom scores for safety, as well as to identify and intervene with patients who exhibit low compliance - before it becomes a trend.
Key Solution Highlights
StudyWorks enables sponsors, site coordinators, monitors and CRAs to know what is happening to the patients in the trial:
- Compliance and enrollment standard data summaries
- Study-specific reports including alerts and eligibility
- Exclusive configurable email alerts based on symptom data and real-time calculations
- Tracking reports of StudyWorks utilization per each individual user
- A convenient calendar view of patient diary compliance
- Updates and data clarifications by authorized users
- Permission-based access to all reports and data
- Full sponsor control of user administration and authorization
- Site-to-subject messaging from StudyWorks to patient devices in the field
- Data transfers in SAS, CDISC XML, and Excel formats
- Data integration with and into CDISC-compatible systems
| StudyWorks Screen Shot Examples | ||
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| Calendar View Visual snapshot of an individual subject's compliance (green = diary received) which allows easy one-click access to specific reports |
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| Detailed Compliance Individual subject compliance, calculated in accordance with the sponsor's custom protocol specifications |
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| Compliance by Country Comparative compliance (and enrollment) at sites across countries; enables sponsors to track global study progress |
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| Compliance Alert Real-time notification for site follow up and intervention if a subject's diary compliance drops below a custom limit |
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Data Transfers and Integration
StudyWorks provides complete access to all data collected and gives authorized users the ability to download data transfers on demand. PHT provides clean transfers in SAS and CDISC Operational Data Model (ODM 1.2) XML formats at regularly scheduled intervals. Data available in StudyWorks can be integrated with and into other EDC or CDMS systems as required per trial.
Learn More about StudyWorks
How do you handle data clarifications and data management? What EDC systems have you integrated? Contact PHT for answers to these questions or any others you may have.
