The eCRF and visit workflow for BE/BA studies: from screening and consent through dosing and sampling to an e-signed data lock.
Built from the first volunteer to the e-signed data lock. Open to three design partners.
Apply for a design-partner pilotWhen a regulator doubts a site’s data, every study run there can be lost. These are the regulators’ actions, with their sources.
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The protocol as configuration: periods, washouts, schedules with typed windows, lab ranges, eCRF forms with rules, a template library, and a two-signer sign-off that locks on first use. Forms can be imported from ODM files: a dry run first, then all or nothing.
Used by: study set-up, data management
Investigational product receipt, dual-control verification, custody, accountability and a restricted blinded codebook.
Used by: pharmacy and IP custodian
From volunteer to the PI’s eligibility decision; every task is started, submitted, reviewed and signed.
Used by: CRCs, principal investigators
Two-step consent, enrollment, randomization from a blinded list, standby and replacement. Compensation is a two-signer schedule with an append-only payment ledger.
Used by: CRCs, clinic operations
Check-in, pre-dose clearance, dosing, every event captured in its window with deviation seconds, meals and restrictions, check-out, and a live clinic board.
Used by: clinic operations head, CRCs, nurses
Collection, processing, aliquots, labels, storage, shipments and chain of custody. Bioanalytical results come back through the Results tab by CSV: a dry run first, all or nothing, with versioned re-assay. Actora exchanges files with your lab’s own LIMS; it is not a LIMS.
Used by: sample processing, bioanalytical, data management
AE, SAE and pregnancy capture, multi-clock tracking including the CDSCO 24-hour SAE clock, four-recipient notification, three-party causality, and PI emergency unblinding.
Used by: PIs, safety physicians
Segregated review (the recorder is never the reviewer), query threads, physician sign-off, a two-signer SDV plan, deviation handling, and medical coding with your own licensed dictionaries.
Used by: QA head, monitors, coders
Files documents against your own copy of the CDISC TMF Reference Model, with e-signed QC and completeness measures. The protocol version and each lock certificate are filed automatically.
Used by: TMF specialist, QA, site staff, inspectors
Freeze, a server-enforced pre-lock checklist and an e-signed data lock, then CDISC Dataset-JSON and CSV, ODM v2.0, casebook PDFs and an inspection pack.
Used by: data management, QA, sponsor liaison
Study board and attention queue across studies, with app-aware search.
Used by: clinic and CRO management
Content-bound e-signatures, hash-chained audit, an audited-transaction guard, access logs and a security-anomaly sweep.
Used by: QA, inspectors, IT
Single sign-on and MFA through your identity provider, step-up re-authentication, a sealed break-glass account, custom roles and app entitlements.
Used by: IT and system administrators
AI Assist is an optional add-on: cited help answers that only propose. It never decides.
Actora ships a validation pack: a requirement matrix joined to the test results of the exact release, plus installation checks against your live instance. Compliance belongs to your validated installation and SOPs.