Streamline your regulatory process with paperless binders and electronic delegation logs.
Store, route and e-sign your regulatory documents
Create study-specific folders and sub-folders, then upload documents and route them for signature. You can route to one or multiple people and select different signature attestations.
Upload licenses, CV's and training documents just once - and let the system do the rest
Use our common folder structure to house frequently used documents such as CLIA waivers, GCP certificates and medical licenses. These files will follow the individual users into each study, so you don't have to keep re-filing. You can choose to turn off a common file at the individual study level.
Bulk sign your documents
Every user has a convenient Overview page where you can see all your to-dos in one place. On this page, you can bulk sign all outstanding documents, across studies, in one workflow. You do not have to sign off document by document, or envelope by envelope.
Build electronic delegation logs
Design your duty codes, then add individual duties to each study staff member. You can also copy code profiles from one user to another. When done, both the PI and delegate will be asked to e-sign, and once both have signed, the duty becomes "active". Individual users can view their own delegation logs from the Overview page, and the Regulatory Specialist can easily track what signatures are outstanding.
Keep track of study trainings
Create training requirements, link them to duties, and have the system tell you who needs to complete what training. Fulfill training requirements by linking documents or marking the user as exempt. Individual users will see all their outstanding training requirements in one place from the Overview page.
Access clinical trial data anywhere
Your study doesn't stop just because you're out of town or not in a clinic. Our system frees you from the burden of paper binders.
Access source data anytime. Enter progress notes and send "stickies" to your team from home or anywhere else.