| 21 CFR Part 11 Compliant
|| Independently audited and specifically designed for clinical research.
Ability to redact PHI (or confidential information) for audits while maintaining original source document.
| HIPAA Compliant
|| A safe and secure home for your subject information.
| Regulatory Binders
|| Cloud-based study startup process drives site startup speed, improves and organizes communication, and eliminates binder reconciliation, and saves time in updating electronic (cloud-based) binders. Eliminates the need to print documents from the EHR to paper and file them into a physical subject binder.
| Subject Binders
|| Enables remote Source Data Verification, eliminating the need for up to 70% of CRA travel while providing access to source documents in days instead of months
| Certified Copy and Electronic Signing
|| Allows for total elimination of paper backups while adhering to FDA guidelines; no more short or long-term storage of paper 3-ring binders.
| Document Expiration Tracking
|| Without having to proactively and periodically check, never miss an expired Medical License, CV, or other document expiration again.
| Document Versioning
|| The most recent version of a document is always served up first, eliminating errors such as using an old version of the consent form, while still allowing access to the previous version history.
| Centralized Trial Document Access
|| Access to all the trial documents in one site as opposed to multiple binders including a single subject binder (unlike in complex trials where more than one is needed). Remote monitoring of all documents.
| Secure Cloud Hosting
|| All data is kept and redundantly backed-up in a cloud hosting environment that is secured by rigorous administrative, physical, and technical safeguards.
| Single Sign-On
|| Industry-best security practice: if a person leaves your company, access is disabled automatically.
Plus, no extra password for users to remember!