Tenvia Protocol Intelligence

Understand the impact.
Before you commit.

Tenvia is a workspace for developing clinical trial protocols. Bring the draft, evidence and team review together, then see what a design choice could mean for participants, sites, budgets and timelines.

Explore a study example

The public demo uses a fictional study. Check product availability ↗

One proposed changeFictional study / DI-101
Protocol draftConsider a wider eligibility age range.
Evidence and assumptionsWhat supports the proposal?

Is the proposed population appropriate?

Review with the study team.Evidence informs. Experts decide.
Illustrative relationships · No live analysis or forecasts

The Tenvia difference

Better decisions. Aligned teams. Fewer surprises.

  • From uncertaintyto informed decisions.
  • From fragmented discussionsto aligned teams.
  • From reactive amendmentsto proactive risk identification.

Bring evidence, protocol decisions and cross-functional review into one connected process—so potential study risks can be identified earlier and teams can move forward with greater confidence.

Evidence-led protocol development

One protocol. Every expert.
Every decision connected.

Reach alignment before decisions become commitments. Tenvia is designed as a collaborative platform where clinical, medical writing, biostatistics, operations, regulatory and CRO teams can build the protocol together around evidence—so everyone can understand the choice, the concerns and the reasoning behind it.

One shared design

The protocol

Every perspective has a place.
Every choice has a reason.

  • Study design
  • Supporting evidence
  • Decisions and rationale
Expert judgement at the centre
  • Clinical DevelopmentScientific rationale
  • Clinical OperationsStudy delivery
  • BiostatisticsEndpoints and analysis
  • Medical WritingClarity and consistency
  • RegulatoryRegulatory context
  • CRO teamsOperational expertise
Illustrative workflow · Explore capabilities and availability

Shared evidence. Connected expertise.Scientific judgement stays with your team.

Explore collaborative protocol development

Build a shared understanding. Then challenge what the design asks of the study.

Protocol Intelligence Import

Your next study should build on everything you’ve already learned.

Turn previous protocols, clinical evidence and study learnings into better-informed decisions for your next clinical trial.

Evidence → decisions → reasoningIllustrative workflow · Fictional study PI-101

Planned workflow: customer document import, analysis and cross-study recommendations. Prepared fictional example; no live analysis or validated clinical advice.

01 / Previous study evidence

Build on previous studies

Bring previous protocols and supporting documents together for a stronger starting point.

Select a document to follow its reasoning.Selected source: Clinical Study Report

02 / Evidence intelligence

Turn evidence into decisions

Connect clinical findings, safety evidence and study learnings to the design choices that matter.

Illustrative source passagep. 42 · §12.2

Clinical Study Report
Safety observations

“Additional safety assessments were recorded between scheduled visits.”

A previous observation can raise a design question. It does not establish the right clinical response.

CSR-101 · final · Source retained in this example

All passages, document references and findings shown are invented.

03 / Informed protocol decisions

Identify risks before they become amendments

Challenge assumptions, potential inconsistencies and operational consequences earlier.

Proposed Phase II design consideration

Does the next study need a different monitoring schedule?

Qualified review required before changing the protocol.

Cross-functional review

Clinical Development · Safety · Clinical Operations

Scientific rationale · monitoring · site workload
Draft decision recordFurther review required

Carry the source, question, reviewer and rationale into protocol review.

Showing the fictional Clinical Study Report passage and its proposed design question.

Historical evidence → design implications → collaborative decisions → traceable reasoningEvidence informs. Your experts decide.

Don’t just reuse your previous protocol.
Understand what it can teach you.

Explore Protocol Intelligence

Decisions and consequences

Stress-test the design. See what deserves another look.

Which assumptions could become difficult to change once your study begins? Explore a protocol choice, examine its evidence and consider the potential consequences while your team can still reconsider the design.

DI-101 One proposed changeFictional study
01 / 04

Explore a wider age range.

Eligibility age range18–75A wider population to consider
Question to resolveWhat is the scientific rationale?

A wider age range changes who the study intends to include.

A proposal starts the review. It does not settle the decision.

Prepared illustration · No live analysis or customer study data

Alongside your existing workflow

Your existing tools.
Better-informed decisions.

Whether your team writes protocols in Word, uses an AI drafting solution or works with an established clinical technology platform, Tenvia is designed to fit into your existing workflow.

Make the next review about the choice itself, with its evidence and open questions in view. Explore where Tenvia could strengthen the decisions your team and CRO partners already make.

  1. 01 · Starting point

    Existing protocol
    or draft

    Your study question, source material and current design.

  2. 02 · Tenvia decision intelligence

    Examine the design.
    Connect the reasoning.

    • Evidence and context
    • Cross-functional review
    • Potential consequences
    • Decision traceability
  3. 03 · Human decision

    A reviewed choice.
    A traceable rationale.

    The responsible team decides, with reasons and open questions tied to a version.

Illustrative workflow. Document intake is separate from system integration. Customer import availability requires confirmation; live connectors to authoring and clinical systems are not confirmed.

Explore inputs and handover

Face study planning with clearer answers.

What will the design ask of sites and patients? Which planning assumptions still need evidence? Bring these questions into the review before the protocol becomes a commitment for the people delivering the study.

Standards in the workflowStructured for a clearer protocol.

ICH M11 informs the protocol structure, supporting consistent organisation and traceable review. Relevant EMA guidance belongs beside the decision, with its region, date and status. Standards alignment does not establish certification or regulatory approval; qualified experts remain accountable.

How ICH M11 informs the approach

Explore the fictional workflow, then confirm the features and controls for your evaluation.

Explore the sample See the full workflow

People make the decisions

Bring your protocol.
Discover what your team could be missing.

Which assumptions would you want to challenge before your next study begins? Explore a sample scenario with our team, then agree what a focused evaluation should demonstrate for yours.

Start with a non-confidential question; agree secure handling before sharing a protocol.

How Tenvia approaches trust and human review
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