Integrated ePRO and Patient-Sourced Data
ClinTrak EDC safely and securely collects information directly from patients using the ePRO/eDiary functionality (or a third-party ePRO/eDiary solution if preferred). The de-identified, patient-sourced data reside in the same database as the site-supplied data. Advanced reporting features, can then be applied to this merged database. In addition, by directly incorporating patient-sourced data, the need to work with third-party ePRO vendors is eliminated, as is the need to reconcile patient-sourced data.
Integrated e-Source Data Reduces Site Burden
Relieving sites of data entry responsibilities dramatically reduces the burden of participating in clinical and observational research. Following the CDISC Healthcare Link standards, ClinTrak rwEDC can connect to an investigative site’s Electronic Health Record (EHR) system, providing the ability to:
- Conduct retrospective studies without having to send costly chart abstractors to sites
- Rapidly add health economic data to ongoing studies
- Efficiently collect vast amounts of local lab data and medication data for observational studies
- Work with sites that had been previously closed to additional studies because of resource constraints
Advanced Online Reporting Offers Transparency and Deeper Insights
Meaningful study data are too often not readily available to Sponsors: rudimentary “standard” reports or costly custom reports are typical. Furthermore, reports of derived endpoints are available only after important data collection milestones and statistical analysis and validation are complete.
The advanced reporting available in ClinTrak rwEDC can increase active participation in the research. Ready access to the study data, including derived endpoints, coupled with the ability to generate sophisticated reports, gives critical data and insights to the Sponsor and Sites that can be used to improve study execution.