Protocol AI Editor and review
The AI checks the protocol against the EU CTR and ICH-GCP as you go.
Read more about Protocol AI Editor and reviewRun the entire clinical trial in one place
Protocol, TMF, signatures, delegation and deadlines in one platform, for large and small studies.
One platform.
From protocol to inspection.
Built for the people who write protocols, run sites and host monitoring visits.
Trial Master File
Completeness per site shows what is missing before an inspection.
Read more about Trial Master FileSign
Study staff sign with a passkey, participants with MitID.
Read more about SignDelegation Log
The PI signs each row, and the staff member countersigns.
Read more about Delegation LogMeeting notes Coming soon
CPR numbers (Danish personal ID numbers) and names are masked, and Adhera drafts the minutes and actions.
Read more about Meeting notesTrial calendar
Deadlines and milestones from the protocol and approvals on one timeline.
Read more about Trial calendarAlongside REDCap.
REDCap remains your data capture system. Adhera takes care of the work around it: protocol, consent, signatures and documentation.
- Inclusion per site is read from REDCap
- Consents are reconciled with REDCap by study ID
AdheraBuilt to ICH E6(R3) and the EU CTR.
You can show who did what and when.
Consent with MitID
The participant signs with MitID, and every page shown is logged.
Unaltered originals
Every file is stored unaltered with its hash.
Access for the inspector
Read access to selected sites with an end date.
Full export
The entire TMF as a ZIP with files, index and audit trail.
Ten modules on one foundation.
A study switches on the modules it needs.
Protocol
Documentation and signatures
See how Adhera can work for your study.
We'll show how it can be set up for you.
