The first intelligence layer in the clinical development lifecycle

Design a protocol that can actually be executed.

Protocol Intelligence and the Evidence Agent work together to understand the proposed design, retrieve relevant precedent, surface implications and turn approved decisions into structured study state.

See how it works ↓
Evidence in contextIllustrative study comparison

Eligibility criterion

Performance status

Current designECOG 0 to 1→Relevant precedentComparable phase II studies
Potential implication · eligible population may narrowSources linked for review
Protocol Agent understands the proposalEvidence Agent retrieves relevant precedentSources and limitations stay attachedPeople retain authority

One controlled lifecycle

Turn study intent into an operating model.

Select a stage to see what changes and what remains under qualified human control.

Start

Bring the protocol in without creating another source of truth.

Start from a blank study or import a DOCX or PDF. The original remains immutable while extracted values wait for qualified review.

Same source. Same baseline. Visible authority.

Study consequences grounded in evidence

Evidence, in context.

Tenvia reads the proposed study, finds relevant evidence and shows how that evidence may affect the design. Reviewers can inspect the sources and decide what action to take.

Current design

ECOG performance status 0 to 1

The proposed study definition and its population assumptions provide the context for comparison.

Sources, assumptions and study context remain available for review.

Review across functions

Each qualified function sees the protocol in the context it needs.

Reviewers work from the same definition and remain responsible for their own decisions.

Qualified responsibility

Clinical Development

Scientific intent, objectives and clinical rationale

Shared context does not dilute authority.

Build internally, collaborate externally or work together in a shared study environment. Controlled review packages can reach people who do not use Tenvia.

Tenvia Study Blueprint

Define the study once, then prepare its execution requirements.

The approved protocol becomes a structured technology, data and operational specification. Every requirement remains traceable to the study decision that created it.

  1. 01

    Define

    One approved study definition that is independent of vendors

  2. 02

    Compile

    Translate intent into change sets for each target

  3. 03

    Authorise

    Validate, compare and obtain human approval

  4. 04

    Deploy

    Release through each supported connector boundary

  5. 05

    Verify

    Record what reached each target environment

  6. 06

    Reconcile

    Detect divergence and prepare governed change

EDCVisits, forms, fields and data requirements
CTMSCountries, sites, milestones and responsibilities
eTMFStructures, milestones and expected evidence
IRT / RTSMArms, cohorts, randomisation and supply intent
eCOA / ePROAssessments, schedules and workflow requirements
LabsTests, specimens, schedules and study metadata
SafetyStudy metadata and workflow requirements
RegulatoryControlled study data and submission context
Explore execution requirements

Logic for individual systems stays outside the canonical study definition. Public examples are illustrative and do not imply a live connector or a price approved by a vendor.

Bring one real protocol decision

Review the relevant evidence and its effect across the study.

See how Tenvia connects execution