Trust & evaluation

Power you
can inspect.

Review the proposed change, examine its cited evidence and identify the version that reaches handoff. In clinstead designer, experts can inspect specific records of how the study was built.

Follow a decision

From a source passage
to a reviewed change.

Inspect the cited passage, the proposed operation and the saved review. Each answers a different question about how the design was built.

Meridian · illustrative decision record
Source
Protocol §4.2Record temperature when fever is reported
Proposal
Add conditional temperature fieldBaseline and Week 4 · °C
Review
Operation acceptedReviewer and decision time recorded
Revision
Study revision 02Saved structure available for comparison
Output
Package from revision 02Source snapshot and artifact identity
Inside clinstead designer

Control at each decision.

01

Review the actual change.

Inspect the individual operations an agent proposes: create a field, change a rule, connect a form to a visit. Refine, accept or reject those operations before they become part of the design.

How it works

Document-derived proposals can include a quoted passage and source page. Review the cited evidence alongside the proposed interpretation; source references are available for supported proposal workflows.

02

See who approved it.

Recorded design actions associate the actor, action and study. Saved AI approvals retain the proposed operations, reviewer and decision time, so a later review can examine how the design developed.

How it works

Saved approval records preserve the prompt, proposal, rationale and available evidence. They support historical inspection alongside the study’s activity history. Record coverage and retention are part of the intended-use evaluation.

03

Compare saved revisions.

Compare saved study snapshots at entity level. See what was added, removed or changed across the forms, fields and relationships that make up the study.

How it works

Snapshot comparison and dependency analysis answer different questions: what changed in the saved design, and what the current structure depends on. Both give reviewers concrete information to investigate.

04

Identify what was delivered.

A compiled package identifies its source snapshot, compiler or adapter version and generated artifacts. File hashes help identify the exact files produced for a handoff.

How it works

Interpretation and compilation are separate steps. AI proposes changes to the study; the compiler translates the reviewed structure through a target adapter. A generated package still needs the receiving system’s import and study acceptance checks.

Robustness by design

Test the logic.
Check the structure.

Preview forms with sample inputs. Exercise conditional visibility and calculations. Check the relationships across forms, visits and arms.

Study-wide checks can surface circular dependencies, references to data collected only at a later visit and gaps across arms. Structural checks can block compilation so the issue is addressed before a package is produced.

Explore the build and review workflow
GxP & intended use

Define the use.
Verify the controls.

Agree which tasks the system will perform, which records it will handle and which decisions it will support. Use that scope to define requirements, assess risk and plan qualification and acceptance evidence.

  1. Define the workflow.System boundaries, responsibilities, study requirements and the target environment.
  2. Evaluate the controls.Access, record integrity, change control, data handling, backup and recovery.
  3. Verify the intended use.Documented checks, acceptance criteria, relevant product evidence and any additional qualification work.

GxP suitability is evaluated for the proposed use and deployment. It is not a blanket product certification.

Bring your technical and quality teams

Start with the work you have. Show us where you want to go.