eCRF forms and validation
Forms, field validation, and approval flows are configured in the interface with every amendment recorded.
Clinical trial data management
The work of EDC, CTMS, and eTMF, configured on one platform
Upload existing CRFs and process files. AI decomposes them into form, progress, and document structures that are built after confirmation. Every record retains its source and approval history.
Book a demoScope
One data and permission model from forms to documents
Study progress
Enrollment progress, visit schedules, and milestones are aggregated from study data.
Document management
Protocols, approval letters, consent forms, and test reports link to the corresponding records.
Approvals and audit records
Approved content, approval actions, versions, and effective periods remain in one process.
Configuration
Form building and amendments are completed in the interface
AI decomposes existing CRFs or enrollment forms into process and data structures for team confirmation. Protocol amendments and mid-study changes use the same configuration and change-record mechanism.
Audit records
Record origins and approved versions are available item by item
- Field-level audit trails retain every modification.
- Electronic signatures follow a 21 CFR Part 11 design, including re-authentication, declared signature meaning, and full signature history.
- Approval records correspond to the approved version.
Compliance status is established through the trial team's processes and validation. PhaseNext provides the system capabilities required to meet those requirements.
Bounded AI
AI parses the documents. A person approves every value.
Fields retain provenance
Each field links to its source position. Low-confidence values are flagged for human review.
Written after confirmation
AI produces candidate drafts. Records are written after permission checks, approval, and human confirmation.
Traceable to source documents
Reviewers can move from structured fields back to the original document for item-by-item verification.
Where it fits
BA/BE studies, small clinical trials, and academically supported studies
Existing systems can connect through APIs and file import as study data is consolidated step by step. PhaseNext is developed and supported by a Taiwan-based team.
Configuration demo