Real World EDC – specially developed for observational studies
RealWorld EDC has been developed specially for post-approval (registry, observational, Phase IV) clinical studies. This is reflected in every aspect of the RealWorld EDC solution and how it delivers specific benefits to late-phase research.
This is what sets RealWorld EDC apart:
- Less demanding for the end-user, providing rich features in a simplified interface
- Minimal disruption at the doctor’s office
- Designed from the team’s perspective to help them complete their work easily
- Less time needed for end-user to complete the study tasks
- All key tasks within three clicks
- Faster study start
- Quick EDC uptake at site with minimal or no training requirement
- Focus the site on patient recruitment, not software
- Little helpdesk support required
Observational studies are different from earlier phase clinical trials. RealWorld EDC takes account of the following differences:
Country differences:
- Data protection (different legislation does not allow uniform data collection across different regions/countries)
- Different language requirements between and within countries
Different set of users:
- Clinicians in practice, not specialist research centres
Post-approval study sites are often operated by doctors in practice who are not experienced researchers. They typically involve large numbers of sites and multiple languages. Data collection methods must make it as easy as possible for the data to be entered accurately by busy doctors and their patients.
Learn more about how RealWorld EDC benefits the study team»