Sequence WebEDC is a full featured, cloud-based EDC solution that is investigator friendly, fully configurable and promotes fast study start-up.
- Feature rich eCRF forms engine capable of handling complex conditional formatting, in-form rules, and calculations
- Embedded eCRFs Completion Guidelines that can be updated by DMs/PMs in real-time
- Robust edit check design module that supports both in-form and cross-form validation
- Simple query management that allows users to update, redirect, or close queries with ease
- Batch PI Signature and DM Locking capabilities to facilitate study close out
- Email notifications can be configured to trigger on any data point
- Integrated Patient Randomization and Coding Capability
- Interactive task-based dashboards and real-time reporting
- Flexible PDF archiving of eCRFs/audit trail for study closeout
- Intuitive user interface with streamlined workflow processes that require minimal training
- Promotes fast study startup
- Extensive metrics and reporting
- Highly knowledgeable and professional team with extensive experiencing in deploying Phase I – IV EDC and other e-Clinical solutions
- Integrated with CISYS’ Industry-leading Medical Coding platform (Sequence WebCode)
- CDISC / CDASH standards
- Fully validated, 21 CFR Part 11 compliant cloud-based solution
Support and Training
- Quick and efficient user training
- In-person training also available onsite at sponsor facilities
- Zero client requirements except browser
- Remote training available
- Technical support and dedicated 800 number per study
- Many levels of help desk and support options available
Security
- Role and workflow-based security
- Customizable event notifications
- Configurable workflow to fit customer’s organization
- Configurable down to the field level
- Configurable actions by role or user
Data / Hosting
- All data will be hosted on a validated, secure server located in a hardened, redundant hosting facility
- Full business continuity and disaster recovery functions provided
- All data will be backed up on a nightly basis both locally and to a different geographic location for redundancy
- 24/7/365 Performance and fault monitoring
- All files will be the client’s property and transferred upon request