Give the Review a Clear Boundary.
Begin with one protocol-amendment pair and one related document class, such as an edit-check specification. Select the approved versions with your study expert and define the questions the review should answer.
INNOVIZZ Insights / Clinical Document Intelligence
See What Changed.
Know What Needs Review.
INNOVIZZ Insights is a clinical document-review implementation for protocol amendments and related specifications. Connect identified changes to source passages, potential downstream impacts and recorded reviewer decisions, so the next owner has the context to act.
For Data-management leads and biometrics teams at sponsors and CROs
First Application / Protocol Amendment Impact Review
One Amendment.
Several Documents to Reconcile.
Finding the revised wording is only the start. A data manager still needs to check related specifications, explain why an item needs attention and get it to the right reviewer.
Keep the Evidence with the Action.
The intended result is a review packet: identified changes, source locations, proposed impacts and recorded decisions. A data-management or biometrics reviewer accepts, revises or rejects each proposal before it becomes an assigned action.
The Engagement / INNOVIZZ Insights
What Your Team Receives.
Begin with one protocol-amendment pair and one related document class, such as an edit-check specification. Agree the selected deliverables and review criteria in the scope.
Source and Review Scope
A document and version register, approved processing route, review questions and agreed acceptance criteria.
At Review
Are the right sources and responsible reviewers identified?
Configured Review Workflow
The agreed comparison and source-inspection workflow, with extraction limits and proposed impacts visible.
At Review
Can the reviewer distinguish a source change from a proposed implication?
Change and Impact Packet
Identified changes, source passages and locations, proposed review items, reviewer dispositions and handoff references.
At Review
Can the team trace an action back to its evidence and review decision?
Evaluation and Handover
Results against reviewed examples, exception records, agreed source or configuration, and operating guidance.
At Review
Does the evidence justify using or expanding this workflow?
A Bounded First Engagement
Agree What a Useful
Review Must Show.
Start with a pilot your team can assess against its current process. The written scope sets the inputs, implementation, reviewer involvement, acceptance criteria, timing and fees before work begins.
- 01
Confirm the Inputs.
You identify the workflow owner, protocol versions, related specification and representative review questions. We confirm source quality, document permissions and the approved processing route with your IT and security reviewers.
Data Management + IT / Security - 02
Test the Review.
Use agreed synthetic or authorized retrospective examples and a reference set reviewed by your study expert. Check source accuracy, missed material changes, unsupported suggestions and how missing or ambiguous information is shown.
INNOVIZZ + Study Expert - 03
Decide the Next Scope.
Your named owner assesses the review packet and total effort, including document preparation, checking and handoff. Receive the evaluation and operating guidance, then decide whether to refine, expand or stop.
Workflow Owner + Acceptance Lead
Keep study approval with your team.
A proposed impact is a review starting point. Changes to specifications, edit checks or study systems follow your authorized review and change-control process. Any qualification, validation or production release is agreed separately.
Before You Commit
Planning Your First
Document Review Pilot.
What Is Clinical Document Intelligence in This Offering?
INNOVIZZ Insights is a scoped implementation for reviewing clinical document changes. It connects before-and-after source passages to proposed review items, the responsible reviewer and a recorded decision. The first pilot can cover one protocol-amendment pair and one related document class; it does not automatically approve clinical changes.
How Is This Different from Document Chat?
The engagement centers on the review outcome: the document versions used, the passages that support a finding, the proposed follow-up and the reviewer's decision. We first assess tools your team already has. A suitable approved platform may be configured for the task; a separate application is included only when the agreed workflow needs it.
Will It Find Every Downstream Impact?
No. The result depends on the sources provided, extraction quality and the scope of the comparison. Proposed impacts need study expertise, and absent documents can leave gaps. The pilot tests material misses and unsupported suggestions against agreed reference examples, with uncertainty visible to the reviewer.
Where Will Our Study Documents Be Processed?
The deployment is agreed with your IT and security team. Before using study documents, confirm the approved storage and model services, user access, processing locations, logs and retention. The public walkthrough uses sample material and accepts no document uploads.
Can Reviewed Items Enter Our Issue Workflow?
Yes, as a defined handoff or separately scoped integration. Agree the item fields, source references, responsible owner and disposition record with the receiving team. A suggestion becomes an issue only through the agreed review process; the walkthrough does not demonstrate a production connection.
How Are Timing, Fees and Support Agreed?
After confirming document readiness, platform choices, review availability and acceptance requirements. The proposal sets deliverables, responsibilities, schedule and fees in writing. Hosting, third-party licenses, ongoing support and later document types are identified separately where relevant.
Clinical / Your Next Decision
Scope One Amendment Review.
Discuss the documents your team must reconcile and the decisions reviewers need to make. Establish readiness and define a pilot with measurable review criteria before agreeing implementation.
Built for Your Team to Operate.
Receive the agreed source or configuration, specifications, test records and operating handover. The statement of work identifies client-owned deliverables, existing INNOVIZZ methods, third-party licenses and support terms.