Efficient and Compliant eCRF
- CRF creation and data entry
- Multi-centric clinical study data capture
- Accelerates validation and processing
- Connects with Randomization, EDC Mobile, and ePro
- Fit for global usage
The Data Challenge
Create an EDC study and collect clinical trial data without the worry of compliance, traceability, missing or inaccurate data. It is possible with Ennov EDC.
Easily design, deploy, and capture multi-center clinical study data with one comprehensive solution.
Ennov EDC is an eCRF solution that can support clinical studies of any size, including very large and complex global trials. Ennov EDC helps facilitate complete and more accurate data, as well as improve communication within teams.
Benefits of EDC
- Comprehensive: software for electronic data capture
- Compliant: covering all international regulatory requirements and standards for Human and Animal health, including FDA, HealthCanada, EMA, ICH, and CDISC
- Efficiency: people are automatically notified
- Global: 24/7 availability
eCRF to Capture Data and Integrate to What You Need
Avoid delayed entries and data errors with electronic data capture. For the same study, capture data with online eCRF, offline eCRF through the iPad, or even paper CRFs.
In addition, with Ennov EDC working in tandem with Ennov ePro, patients can record their own diaries and quality of life assessments. Our intuitive EDC software significantly streamlines randomization, study design, consistency tests, medical coding (MedDRA, WHO Drug), data import and export.
You can design your own eCRF and administer your entire study without any IT skills thanks to our study administration and graphical eCRF creation tools.
Utilizing the Online CRF
All clinical studies created with the CDMS designer are accessible via the internet, with our native online CRF solution. Ennov EDC increases traceability, security, and confidentiality compared to a paper CRF.
All types of clinical studies can be entered via the internet (including international and multi-centric clinical trials, post-marketing studies, cohort studies, health surveillance, Phase I, II, or IV studies, and epidemiological studies).
Fully Integrated with the Ennov Clinical Solution
The design of the eCRFs for EDC Mobile is done with the Ennov Clinical software suite. The studies can be carried out simultaneously with EDC Mobile and the standard EDC input module.
- Compliant with FDA recommendations in terms of safety and trial audits
- Easy data collection to create CRFs 3x faster
- Simple: create topics, navigation, and typing in eCRF
- User-friendly: configure and input without needing IT experience
- Entry of eCRFs
- Profiting from the iPad/tablet
- Navigation and typing in eCRF
- Secure connection
- Create, lock, sign, and exchange CRF template
- Study documentation
- CDISC certified
- Full web interface
- Fully integrated with Ennov Clinical
Cloud-based or On Site
EDC – one of our Clinical Solutions
Why Choose Ennov ?
Hundreds of corporate customers trust Ennov
- 15 Years of experience in Clinical
- 150+ life science customers, many more in other industries
- Modern architecture and interface
- Application server for scalability
- You matter to us
- 98.5% of projects delivered on time and within budgets
- High and improving customer satisfaction
- Use of human resources: time spent on various steps
- Compare activities over similar products / period of time
We respect your freedom of choice
- Available as cloud or on premise
- You can switch between options at any time
- We make you autonomous
- Configuration requires no IT skills
- Improved security and optimized performance
- Data is hosted locally for total flexibility
- Full range of pre-integrated clinical study tools
- Based on our high end EDMS/BPMS platform
Structuring AND intuitive
… patients …
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