of 950 phase I–IV protocols in a 2022 Tufts CSDD dataset had at least one amendment.
Getz et al., 2024 ↗Tenvia Protocol Intelligence
Design the protocol.
Understand the study it creates.
Develop the clinical protocol with your team in one place. Connect an objective to its endpoints, tests, visits and supporting evidence. See which choices raise questions for sites and participants, bring the right specialists into the discussion and keep the reason for each decision with the protocol version.
RD-204 · A protocol storyFictional example · No live AI
01 / 04
Change one thing.
Add two collections. Keep the study question in view.
Try the study challengeRD-204Exploratory blood sample
Proposed visit schedule
One collection.
Or three?
Week 4Collection
Week 8+ Collection
Week 12+ Collection
Scientific justification remains open.
Explore the detailed protocol views
Start with the study question
What would another sample help us learn?
The working proposal is to explore biomarker patterns across selected visits. The team needs to connect that purpose to the assessment and justify the sampling frequency.
Explore the sampleTry the fictional protocol questions in your browser.Open the demo →
Evaluate with your teamStart with a non-confidential study question.
Plan your evaluationExplore capabilities, availability and the scope for your team.Explore product scope →
Follow a protocol question
Find the question before it becomes rework.
In the RD-204 sample, a collection is scheduled but has no clear link to a study objective or endpoint. That is a question for the team to investigate.
Exploratory blood collection
What is this procedure here to do?
The sample lists ten minutes of collection time. Its scientific purpose is not linked to a study objective or endpoint in this partial design.
What the team can see
- Scheduled item
- Exploratory collection
- Purpose link
- Missing in this sample
- Next action
- Check the source and clinical rationale
Finding a gap does not determine whether to retain, change or remove the procedure.
See the original product image and its limits
This image uses a fictional study. It shows one part of the product experience, not a complete customer workflow or protocol approval.
Open the original image in a new tab ↗A separate RD-204 example asks what happens when collections are added at two more visits. What work does that create, and what evidence supports it? Compare the schedule below →
The connected study
One protocol choice.
The whole study in view.
A proposed procedure affects more than a line in the protocol. Bring its purpose, evidence, schedule and review question into the same conversation.
What informs the choice
Start with the context.
- Draft protocol
- The proposed procedure
- Study objective
- Purpose link missing
- Supporting evidence
- Not supplied in this example
A question in the study design
Why is this collection scheduled?
The fictional protocol includes an exploratory blood collection, but no purpose is linked to an objective or endpoint.
Review needed · No decision madeWhat the team examines
Follow the connections.
- Schedule
- At which visits?
- Site and participant time
- 10 minutes declared per collection
- Clinical review
- Is the procedure justified?
The intended decision path
- 01Notice the gap
A procedure has no stated purpose.
- 02Examine the basis
Check the source and supporting evidence.
- 03Discuss the choice
Bring the relevant specialists together.
- 04Record the reason
Keep the human decision with the version.
Stress-test a design choice
See the workload behind the design choice.
Compare one collection with three in the fictional RD-204 study. Adjust the time per collection and an optional hourly rate to see how the workload and direct collection cost change. Then ask whether the extra work supports a study objective.
Sample schedule comparison. Confirm the editing and checking workflow for the product version you evaluate.
RD-204 / Exploratory blood sample
What happens when
one becomes three?
120 fictional participants. Explore your assumptions.
Week 4✓Collection
Week 8+No collection
Week 12+No collection
10 minper participant
20 hoursacross the study
A Week 4 collection. Is its scientific purpose clear?
Direct cost: rate needed
Enter an illustrative hourly rate to compare this cost component.
Inspect the calculation and what still needs evidence
Collection-hours = 120 participants × collections × minutes ÷ 60. Direct collection cost = collection-hours × your entered hourly rate. Default duration: 10 minutes; no rate or commercial quote is supplied. Entries stay in this browser session.
Assumes complete attendance. Excludes other procedures, travel, waiting, overheads, consumables and contract terms. Collection time is not elapsed study duration. Recruitment, site capacity and first patient in require separate feasibility evidence; no forecast or total study budget is calculated. Scientific purpose and human review remain open.
Explore the four review questions
One test or procedure. Four questions.Guided sample
Start with the purpose
Why is this test or procedure included?
The sample appears in the visit schedule, but its purpose is not stated. The clinical team needs to clarify which study objective or endpoint it supports.
- Objective or endpoint link
- Not stated
Question to take into review
Which study objective or endpoint justifies this collection?
A missing reason creates a question for the team. It does not mean the procedure should be removed.
This first view shows the question in draft v0.2. Follow the source and fictional team review below. The example decision defers additional collections pending scientific justification. No real study or formal approval is shown.
Take the next step: examine the source, hear the concerns and record a draft response.
Try the sample studyWhy early review matters
Better questions belong in protocol design.
Research points to the value of examining protocol choices with the people who will interpret and deliver them.
of 823 respondents to a UK recruiter survey supported earlier review of eligibility criteria.
Cragg et al., 2021 ↗Industry research, not Tenvia results. The Tufts study judged 77% of amendments unavoidable. Neither figure predicts enrolment or first patient in for a Tenvia study.
Evidence in context
Use earlier changes to ask better questions now.
Explore how earlier protocol changes and their recorded reasons can reveal assumptions worth challenging in your own design.
FICTIONAL HISTORICAL EXAMPLE · HX-101
Repeat the assessment
Screening assessment must be repeated at the study site.
Review an existing assessment
A documented assessment from a referring site may be reviewed against the protocol’s requirements.
Reason recorded in the amendment
The fictional amendment summary records difficulty arranging repeat assessments before screening.
The question for your study: Could this assessment requirement create the same screening difficulty, and would reviewing a referring-site assessment be appropriate?
Examine the evidence and limitations
- Source
- Fictional HX-101 original protocol §5.1, amended protocol §5.1 and amendment summary §2. All three are prepared website examples.
- What remains unknown
- No screening-rate dataset or post-amendment outcome is supplied. The change does not establish that recruitment improved.
- Relevance to a new study
- Clinical context, population, assessment method and timing need specialist review. A historical amendment does not prove the original choice was wrong.
Historical source coverage and retrieval depend on the evaluation scope.
Explore the amendment examplePeople make the decision
Bring different concerns into one clear discussion.
Medical, Operations and Statistics can see the same question through different lenses. Keep their concerns and the Sponsor’s reasoning with the protocol version.
ATTENTION REQUIRED · FICTIONAL RD-204
One decision.
Three necessary perspectives.
Challenge raised
Could repeat screening add avoidable work?
Examine repeat visits, referral records and site capacity. The historical change is a prompt to investigate, not evidence that our study should copy it.
Work through this decision- Why you are involved
- The screening requirement touches your discipline and the same decision needs other specialists.
- Historical signal
- A fictional predecessor changed a related assessment requirement. Applicability remains open.
- Next action
- Review the evidence, respond to the concern and preserve the rationale.
Illustrative attention workflow. Customer assignments, required reviews and approval controls need confirmation for the evaluated release.
The public perspectives are prepared examples. Named assignments, permissions and formal approvals need confirmation for a customer evaluation.
Explore with your team
What would a clearer decision mean for your team?
Start with a sample study, then agree the workflow and success measures for a focused evaluation. Arrange secure handling before sharing a protocol.
Further product detailExplore source intake, review, integrity and product scope
Product model and availability
The diagrams explain the Protocol Intelligence model through representative protocol elements.
- Public examples
- Three fictional RD-204 scenarios cover a collection schedule, historical HX-101 eligibility amendment and imaging-window preflight. The passages, site and patient/public perspectives are prepared for demonstration; the public guidance excerpt supplies methodological context only. Other screenshots use a separate 180-participant example. The source-intake, synthetic benchmark, schematic, playbook, disagreement and output-pack illustrations describe planned capabilities; the public-study identifier is a placeholder, not a retrieved record. Confirm available features when agreeing an evaluation.
- Evaluation scope
- For each evaluation, Tenvia confirms which document inputs, team collaboration, public evidence sources, related-protocol checks, review records and outputs are available. The interactive examples show review questions; they do not assign named reviewers or create live tasks.
- Evidence and interpretation
- Sources, dates, permitted use and relevance need examination. If a reason is unclear, the team needs to review it. That alone is not a reason to remove a procedure. The diagrams show links the team should review. They do not predict results or make clinical decisions.
- Decision responsibility
- The Sponsor’s responsible clinical, scientific, statistical, operational and regulatory specialists make the decisions. Protocol approval, submission readiness and regulatory acceptance require their own controls and validation.
Start with the study
From a protocol draft
to a reviewable study design.
Planned capability · Fictional illustration
Your study doesn’t start with a blank page.
Bring the context into the design. Keep what the source says separate from what Tenvia proposes.
Existing protocolInvestigator’s BrochureSynopsis / concept sheetSponsor standardsSupporting evidence
- 01 / Source factWeek 4 sample specifiedExample protocol v0.2 · p. 18 · §6.2
- 02 / Suggested changeLink the sample to its purposeSuggestion for review · reason still needed
- 03 / Human-confirmed draftPurpose needs specialist reviewFictional reviewer correction · v0.3
How the source stays connected
In the planned workflow, the original document, version, page or section and extraction limits remain linked. Facts, inferred proposals, corrections and confirmed draft content have distinct attribution. Confirming extracted information does not approve the protocol. Unreadable or missing material stays visible.
AI may structure supplied regimen and safety information for qualified review. It cannot invent novel dosing, escalation or safety rules.
Illustration only. No file upload or extraction runs here. Supported formats, permitted use and secure handling must be confirmed for an evaluation.
Planned disagreement intelligence · Prepared fictional discussion
Disagreement shouldn’t disappear into comments.
See who disagrees, why it matters, who is affected and how the decision was resolved.
Clinical proposes
Change eligibility to ECOG 0–1
Candidate in draft v0.3. Study-specific rationale needs review.
Concern retained
RD-204 · proposal E-03 · draft v0.3Clinical Operations: recruitment feasibility still needs examination.
Every step is prewritten fiction. These controls inspect the example; they do not submit a response, manufacture consensus or grant authority. Persona labels create no permissions. Material decisions remain human.
Follow the collection discussion
RD-204 / Exploratory blood sample
A conversation that changes the draft.
Comment attached to the assessment
MW
Medical WritingResponse · Draft wording to revise
“I’ll clarify the visit wording and keep the scientific justification as a separate question for Clinical Development.”
Wording linked to this discussion
v0.2 · Starting wording
Exploratory blood sample at Week 4.
Purpose not stated in the draft.v0.3 · Proposed wording
Exploratory blood samples at Weeks 4, 8 and 12, within scheduled visits, to explore biomarker patterns. Scientific justification and sampling frequency require specialist review.
Preview of the revision prompted by this discussion.Team responsibilities · Review product scope
Clinical Development
- The challenge
- The reason for a test or procedure can become separated from the study objective.
- The Tenvia approach
- Develop the objectives and endpoints with the team, and record the scientific reason and evidence for each proposed test or procedure.
- Why it matters
- A clear explanation of why each item belongs in the protocol.
Clinical Operations and CRAs
- The challenge
- Visit instructions may look complete on paper while practical questions remain for sites.
- The Tenvia approach
- Bring site experience into protocol review. Discuss visit timing, procedure requirements and site capacity, and keep the response with the proposed design.
- Why it matters
- Focused review of patient time, samples, site workload and screening assumptions, with concerns and responses beside the decision.
Investigators and site coordinators
- The challenge
- A design choice may depend on local equipment, staffing, result turnaround or visits that a site cannot deliver as written.
- The Tenvia approach
- Ask a short, decision-specific question and keep each site concern, alternative and Sponsor response on the exact version. External participation requires qualified identity and scoped access.
- Why it matters
- Site-specific feasibility issues become visible during design. An investigator response does not approve the Sponsor protocol.
Biostatistics
- The challenge
- Changes to endpoints or visit timing can affect the planned analysis.
- The Tenvia approach
- Contribute to endpoint and measurement decisions, explain the statistical assumptions and record which changes need another review.
- Why it matters
- A clearer record of which design changes need statistical review. Statistical analysis remains with your team.
Regulatory Affairs
- The challenge
- A document can be complete while its justification or regional review questions remain unresolved.
- The Tenvia approach
- Review the reasons, sources, open questions and exact protocol version before handing it to the regulatory team.
- Why it matters
- A documented basis for preparing the application. Your regulatory team retains submission responsibility.
Medical Writing
- The challenge
- Comments and changes spread across sections, versions and email threads.
- The Tenvia approach
- Develop the draft with specialist contributors. Resolve their comments while keeping agreed wording, reasons and earlier versions together.
- Why it matters
- An easier way to resolve comments and check that sections agree.
Explore the connected protocol model
Structured protocol development
Don’t just write the protocol.
Structure the study behind it.
A test, procedure or questionnaire should show why it is included, which evidence supports it and which specialists need to review it. Tenvia keeps that information connected to the relevant protocol sections.
Study information
- Objectives
- Endpoints
- Population
- Eligibility
- Assessments
- Schedule of Activities
- Statistics
Information kept with the design
- Evidence
- Reasoning
- Assumptions
- Related decisions
- Responsible reviewers
- Decision history
- Source / version history
Match study fields to the standardKeep the source and version. Show fields that do not match.
Protocol documentStudy content for review
Structured representationICH M11 · Mapping target
Example protocol structure · Confirm the file formats and standards your outputs must meet.
Why now · ICH M11
A common structure.
A clearer basis for review.
ICH M11 gives Sponsors and CROs a common structure for protocol content and electronic exchange. FDA issued final M11 guidance in May 2026, alongside the template and technical specification.
Tenvia’s approach keeps the evidence and assumptions beside the study design. Reviewers can see both the proposed choice and the reason for it.
ICH M11 is a reference for organising Tenvia’s study information. This does not confirm that any exported file meets the standard.
Source: FDA M11 guidance, template and technical specification · May 2026Standards and document outputs
Other references include the CDISC Unified Study Definitions Model (USDM) and, where appropriate, the TransCelerate Common Protocol Template. Retain source information and identify any fields that cannot be transferred to the selected standard.
For an evaluation, agree which outputs are available: a protocol document, structured study data, a report showing how fields match the standard, decision history and amendment records.
When study fields are matched to a standard, their source references and any unmatched fields must remain visible. A field match does not establish compliance.
Standards and regulatory boundariesInspect the public guidance example
PUBLIC SOURCE01
ICH E8(R1) · §2.1 · Printed page 2
General Considerations for Clinical Studies
“all study procedures and assessments are necessary from a scientific viewpoint and do not place undue burden on study participants.”Inspect the original guidance (PDF)
Step 4 guideline · Adopted 6 October 2021.
Excerpt selected for this website example.
Applied to the RD-204 review questionA source adds context.
A source adds context.
The team determines relevance.
- What it contributes
- A general principle for examining scientific necessity and participant burden.
- What it cannot establish
- It does not justify this biomarker, this population or collections at Weeks 4, 8 and 12. Study-specific clinical evidence is not supplied in this example.
- The question to take forward
- What scientific evidence supports the additional collections, and is the added procedure time justified?
Tenvia Protocol Integrity · Planned capability
Catch the question.
Keep the resolution.
A potential inconsistency needs evidence, an owner and a human response. Protocol Integrity brings those checks into the Protocol Intelligence workflow.
Consistency
Find conflicting instructions and broken study relationships.
Evidence
Inspect what supports a decision, and what remains uncertain.
Change
See which assumptions, people and study elements need another review.
Inherited decisions
Check the reason and amendment history before reusing a choice.
Amendments
Keep the change, rationale, impact and human decision with its version.
Endpoint timing conflicts
with the study schedule.
The endpoint says Week 12. The SoA schedules its assessment at Week 16. Which timing does the team intend?
- Prepared source passages
- §8.1: “Primary efficacy assessment at Week 12.”
SoA row 4: “Primary efficacy assessment — Week 16.” - Affected review
- Endpoint · assessment · SoA · analysis intent
- Evidence limit
- These invented passages establish a mismatch in the example. They do not establish the appropriate assessment time.
Prepared browser-session illustration. No live AI, assignment, clinical review, persistent record or electronic signature. Customer issue handling and readiness enforcement require release-specific qualification.
Planned capability · Fictional illustration
See the study the protocol creates.
Select a visit. Follow its purpose, evidence and the questions it creates.
Cohort A · intervention unspecifiedCohort B · intervention unspecified
Week 4
RD-204 · draft v0.3- Purpose
- Collect an exploratory sample at an existing visit.
- Linked objective / endpoint
- Exploratory objective · rationale to confirm
- Evidence
- Example protocol v0.2 · p. 18 · §6.2
- Dependencies
- Purpose, visit window and laboratory handling need review.
- Participant burden
- Additional blood/sample burden is unquantified.
- Site workload
- Collection, preparation and shipping require site review.
- Open review / disagreement
- Clinical and Statistics need to confirm purpose.
- Downstream data impact
- Collection timing and sample metadata would be affected.
Prepared outline of a planned structured-study projection, not a second source of truth. Both cohorts use this illustrative visit pattern. No dosing or clinical schedule is inferred; unknowns remain unknown.
Planned capability · Fictional illustration
Your standards, built into the review.
Sponsor Oncology Standard v4Fictional sponsor playbook · pinned to draft v0.3
- PresentRequired endpoint rationale
- AppliedPreferred terminology
- ReviewVisit-window exception
- DeviationDesign differs from sponsor standard
What an exception needs
The intended workflow retains the exact playbook version, deviation, reason and responsible human review. Updating a playbook never silently changes an existing study or approved decision. Sponsor policy is distinct from scientific adequacy and regulatory requirements.
Prepared check results. No document is checked here and no compliance conclusion is made.
Design Benchmark · Synthetic cohort · Planned capability
Proposed eligibility criterion
Example draft v0.3ECOG 0–1
31 / 42
fictional comparison studies include ECOG 0–2
ECOG 0–2 · 31ECOG 0–1 · 11
In this invented cohort, the proposed criterion is narrower than much of the comparison group.
This does not establish that ECOG 0–2 is clinically appropriate for this study.
View studies
These 42 study IDs are invented examples, not registry records or retrieved clinical evidence.
| Example ID | Eligibility |
|---|---|
| EX-001 | ECOG 0–2 |
| EX-002 | ECOG 0–2 |
| EX-003 | ECOG 0–2 |
| EX-004 | ECOG 0–2 |
| EX-005 | ECOG 0–2 |
| EX-006 | ECOG 0–2 |
| EX-007 | ECOG 0–2 |
| EX-008 | ECOG 0–2 |
| EX-009 | ECOG 0–2 |
| EX-010 | ECOG 0–2 |
| EX-011 | ECOG 0–2 |
| EX-012 | ECOG 0–2 |
| EX-013 | ECOG 0–2 |
| EX-014 | ECOG 0–2 |
| EX-015 | ECOG 0–2 |
| EX-016 | ECOG 0–2 |
| EX-017 | ECOG 0–2 |
| EX-018 | ECOG 0–2 |
| EX-019 | ECOG 0–2 |
| EX-020 | ECOG 0–2 |
| EX-021 | ECOG 0–2 |
| EX-022 | ECOG 0–2 |
| EX-023 | ECOG 0–2 |
| EX-024 | ECOG 0–2 |
| EX-025 | ECOG 0–2 |
| EX-026 | ECOG 0–2 |
| EX-027 | ECOG 0–2 |
| EX-028 | ECOG 0–2 |
| EX-029 | ECOG 0–2 |
| EX-030 | ECOG 0–2 |
| EX-031 | ECOG 0–2 |
| EX-032 | ECOG 0–1 |
| EX-033 | ECOG 0–1 |
| EX-034 | ECOG 0–1 |
| EX-035 | ECOG 0–1 |
| EX-036 | ECOG 0–1 |
| EX-037 | ECOG 0–1 |
| EX-038 | ECOG 0–1 |
| EX-039 | ECOG 0–1 |
| EX-040 | ECOG 0–1 |
| EX-041 | ECOG 0–1 |
| EX-042 | ECOG 0–1 |
View matching method
- Why they match
- Same fictional indication · Phase II · similar treatment setting · similar target population.
- Method
- Prepared example: 42 invented records, no exclusions or duplicate IDs. Count criterion labels; denominator is all 42.
- Source / date
- Prepared website example, 2 October 2026. No registry snapshot or live retrieval.
- Missing information
- The toy criterion labels are complete. Real full protocols, amendments, clinical comparability and applicability have not been assessed.
- Interpretation
- A descriptive count, not a confidence interval, recommendation, recruitment estimate or probability of success.
Clinical / Statistics review questions
Does the cohort fit the actual study question? What clinical rationale supports the narrower criterion? Which recruitment assumptions need reassessment? These are prepared prompts; no reviewer is assigned or notified.
The planned product must disclose real study identities, permitted sources, deduplication, method, dates, missingness and limits beside the decision. No live cohort is claimed.
Review complete → Sponsor release → Handoff
A clear finish.
A complete story behind it.
See what remains, who must act and what goes with the final document.
- 01Import or start
- 02Develop together
- 03Resolve reviews
- 04Sponsor release
- 05Word, PDF + record
Illustrative review checklist
3 checks remain
Know what is still open.
Try resolving the fictional checks. The Sponsor step stays separate.
Fictional checklist only. Clicking does not verify evidence, sign or release a real protocol. In the intended workflow, an authorised Sponsor person releases the exact version under the Sponsor’s procedures.
Protocol Intelligence Record · Sample trail
Follow the reasoning back to its source.
SourceProtocol v0.2 · Visit schedule · Exploratory sample
The intended record also retains assumptions, comments, review dates, changes and jurisdiction considerations behind the final Word and PDF documents.
Open the full fictional recordPlanned output scope · Illustrative pack · Not downloadable
Draft documents for review
RD-204 · draft v0.3One study version. The protocol and the reasoning behind it.
- Protocol.docxv0.3 · draft
- Protocol.pdfv0.3 · draft
- Study Synopsisv0.3 · draft
- Schedule of Assessmentsv0.3 · draft
- Decision Recordv0.3 · draft
- Evidence Appendixv0.3 · draft
- Assumptions Registerv0.3 · draft
- Change / Amendment Summaryv0.3 · draft
Change once. Know what else needs attention.
Prepared example: an endpoint definition changes in a candidate v0.4. The assessment schedule stays the same in this toy change.
- Protocol / synopsis
- Affected · new drafts require review
- Schedule of Assessments
- Unchanged in this example · real dependencies still need checking
- Evidence Appendix
- Replacement draft prepared for review
- Change summary
- Prepared against v0.3 → candidate v0.4
Earlier approved artifacts are retained. Preparing a replacement never releases it. Template, mapping, source and decision versions must accompany the actual output.
These cards describe planned artifacts. They do not generate files or certify readiness. Missing content, required reviews, Sponsor release and each export/sharing permission remain separate gates.
Future direction
A starting point for the systems that follow.
Future handoffs could carry agreed study information into EDC, eCOA, RTSM, labs and other systems. Each connection needs verified mappings, permissions and its own agreed scope.
Check the connection requirementsEDCeCOARTSMLabsOther systems
Future architecture within the Protocol Intelligence direction. No second current product or live connector is claimed.
Future self-service experience · Illustrative
Explore a public study.
A bounded starting point for a design conversation.
Concept preview · Personalised analysis is not available here
Placeholder identifier. No study is retrieved and these cards are not findings about this identifier.
- Public study structure
- Available evidence
- Comparable-study preview
- Selected design observations
- Missing information
- What public data cannot determine
This link opens the fictional product journey. A real public-study preview needs qualified source access and release controls. No confidential upload, report delivery or personalised analysis is exposed.
Future direction · Study learning
Keep today’s reasoning ready for tomorrow’s evidence.
The longer-term goal is to connect protocol decisions with authorised study observations: recruitment, screen failures, missed assessments and later amendments. Compare what was planned with what was observed, while keeping uncertainty and alternative explanations visible.
Operational integrations and customer-history learning are future scope. Private study evidence must stay within agreed organisation and study permissions; cross-customer pooling is not included.
Review the future scope
“Are the proposed Week 8 and Week 12 collections within the scheduled visits? The draft should distinguish collection time from the full visit.”