Protocol intent
Primary endpoint
Change from baseline in the study symptom score at Week 24.
Source trace§3 · Objectives and endpointsSB-301 · draft v0.2 · END-01
Reviewer confirmation neededEvidence and rationale stay with the review question.
Tenvia Protocol Intelligence
From protocol
to study build.
One connected path from study design to execution.
Design the protocol, align the team and carry the reasoning into the next handover. Explore Tenvia’s direction for turning governed study decisions into actionable build requirements.
The next team needs more
than a document.
When clinical intent is translated into visits, forms and data fields, the reasons behind a requirement can be lost. A connected Study Blueprint is designed to preserve the source, context and review status—reducing the need to reconstruct the decision at every handover.
TENVIA · STUDY DESIGNSB-301 · Fictional Phase III study
01 / 03
Make the intent clear.
Start with the protocol and the choices your team needs to understand.
Import direction: map an existing protocol, retain its source and confirm what was understood. This example does not upload files.
Study assumptions · supporting evidence · cross-functional decisions · version history
Showing design the study: primary endpoint.
Prepared example of the product direction. No live extraction, blueprint generation, approval, export or system configuration. Review evaluation scope ↗
The structured bridge
A Study Blueprint.
A shared basis for the build.
Organise objectives, endpoints, visits, assessments, eligibility and data requirements alongside study metadata and their source. Keep reviewer confirmation and outstanding mapping questions visible before requirements move forward.
ICH M11 and USDM alignment are design objectives. This illustration does not establish certification or complete conformance.
Preparation before configuration
Review the requirements.
Then prepare the handover.
The intended outputs include EDC specifications, proposed electronic case report forms, data fields, edit-check requirements and endpoint-to-data traceability. Responsible experts must confirm the mapping and approve the handover.
No production EDC deployment is demonstrated. Export formats, validation and integration support require separate verification.
Amendment-aware study build
When your protocol changes,
understand what needs to change with it.
One protocol change can reach beyond the document. Explore possible effects on study requirements before the next handover.
SB-301 · Assessment timing
Week 8Week 8
Start with the assessment at Week 8. Apply the prepared change to explore what may need review.
Prepared comparison · no live change detectionConnected requirements to examine
Your team validates the consequences.
A timing change is confirmed in the example. Its effects on forms, checks and materials remain review questions.
Inspect the illustrative review record
- Source and rationale
- Fictional amendment A, §1.3: assessment timing revised to match the proposed review schedule. Clinical rationale requires confirmation.
- Responsible reviewer
- Clinical Operations lead · example assignment only
- Acknowledgement
- Example record: review request acknowledged. Impact validation and approval remain pending.
- Handover
- Not released. Confirm requirements, approvals and affected systems before implementation.
Prepared record; no real assignment, acknowledgement, audit event or approval is created.
Alongside your clinical systems
Your systems execute.
The context travels with them.
Tenvia is a decision intelligence and collaboration platform for clinical development. Protocol Intelligence connects the design discussion with the requirements downstream teams need; it does not replace an EDC platform.
A longer-term integration path.
Medidata Rave and other EDC platforms are future integration targets. No live connector, vendor partnership, certification or validated interoperability is claimed.
The objective is a reviewed, traceable handover. Configuration, testing and release remain subject to the receiving system’s controls.
Explore with your team
What gets lost between your protocol and your study build?
Bring one non-confidential handover question. Explore the illustrative workflow with us and agree what a focused evaluation would need to prove.