Stress-test the decisions that shape your study.
Challenge the rationale for procedures, examine visit-schedule assumptions and identify the questions that need specialist review before committing to the design.
The Tenvia buyer guide · 1 October 2026
Explore how evidence, assumptions and specialist perspectives shape a protocol decision. Focus your demonstration on the questions that matter to your study and agree how your team will assess the value.
Public guide. No confidential study information is needed.
Start with the problem
Start with a protocol decision whose reasons, evidence and comments are spread across documents and messages.
Challenge the rationale for procedures, examine visit-schedule assumptions and identify the questions that need specialist review before committing to the design.
Bring your protocol-development challenges, therapeutic context and team workflow. We’ll focus the demonstration on the decisions that matter to your study.
Protocol development brings together scientific reasoning, evidence and operational judgement. Explore Tenvia’s approach to connecting these perspectives around the decisions that shape the study. Explore capabilities and availability →
Word, Teams and an approved AI assistant
Your existing tools may already support a strong process. The question is whether keeping the study item and its reasoning together reduces the work of bringing comments and decisions together while meeting your quality requirements.
| Task | A document-led workflow | Tenvia’s illustrated approach | What to test |
|---|---|---|---|
| A proposed change | Wording and context can be spread across documents, messages and meetings. | Keep the proposal alongside the affected assessment and schedule. | Find both starting and proposed wording without searching through the whole discussion. |
| Evidence and assumptions | Links and working assumptions may be recorded separately from the edit. | Keep the source, limitation and open question beside the design choice. | Explain what each source supports and what remains unproven. |
| Specialist review | The team brings comments together and identifies unanswered questions. | Connect comments and responses to the same protocol item. | Identify who needs to review, what was clarified and what remains open. |
| Decision and later handover | The final document may not retain the full reasoning from the discussion. | Keep the proposal, evidence, response and decision with the relevant protocol version. | Understand why the decision was made and check that the agreed records can be handed over. |
This is a workflow comparison, not a measured competitive benchmark or a claim that other tools cannot achieve these outcomes. Test the exact Tenvia release against your actual process.
An approved assistant may help draft or summarise content. Explore the value of keeping study details, evidence, questions and decisions connected throughout review. Assess the workflow against your current process. The public demo uses prepared content without live AI.
Documents, templates and handover
Define the source documents, templates and outputs your team needs. Use the format guide below to agree the supported workflow for your evaluation.
| Material | What is confirmed today | What to inspect before use |
|---|---|---|
| Study question / non-confidential summary | Suitable for an introductory discussion. | Describe the decision and current process; do not attach confidential study files. |
| Word / DOCX, PDF and scanned protocols | Customer import support not published. | Check accepted file types, tables, text recognition in scans, source references and how to correct extracted information. This website has no protocol-upload feature. |
| Sponsor templates, tracked changes and comments | Compatibility not published. | Check whether templates, numbering, tables, references and tracked changes are preserved, and whether reviewers can work outside Tenvia. |
| Protocol document export | Customer Word/PDF export not confirmed. | Request an output from the evaluated release. Check content, formatting, version, references and review status. |
| Decision record / version history | Printable fictional example available. | The example shows what a decision record could contain. Confirm whether customer downloads include all records, attachments and the required audit history. |
| ICH M11 / USDM structured data | Reference standards; compliance not verified. | Identify the exact standard version, supported fields, unmatched content, validation method and available file format. |
| Exit and handover | Must be agreed for your service. | Agree return formats, record completeness, access end date, retention, deletion and backup treatment before starting. |
Include your Word templates, tracked-change process and document handover in the evaluation plan. A Word add-in and round-trip editing are not confirmed as available; see the product scope before planning either workflow.
Evidence access and limitations
Examine source relevance, freshness and limitations alongside the protocol question. The guide below distinguishes public references from confirmed search access.
| Source | Current public evidence | Interpretation and checks |
|---|---|---|
| ICH E8(R1) guidance | Public example linked now | A manually selected source supplies design context. It does not justify the RD-204 biomarker or collection frequency. |
| ClinicalTrials.gov / AACT | Live access not demonstrated | Confirm searchable fields, update dates, registry limitations and matching by population, phase and design. |
| PubMed / Europe PMC / open-access literature | Live access not demonstrated | Distinguish abstracts from permitted full text; retain citations, source dates, relevance and contradictory findings. |
| FDA / EMA / other ICH material | Selected public references available | Links are not a live monitoring service. Confirm jurisdiction, document status, retrieval date and source coverage. |
| Public protocols, amendments and clinical study reports | Coverage not published | Confirm lawful access, reuse rights, version lineage, original/amended documents and amendment summaries. Show unavailable versions and unknown rationale; a registry edit is not automatically a protocol amendment. |
| Your internal study library | Connection not confirmed | Agree permissions, source history, confidentiality and which studies can access internal material before using it. |
Keep the question open. Ask to see how the evaluated release exposes missing sources, contradictory findings, outdated material and limitations. Finding a similar study does not prove that its design is right for yours.
Assess the evidence
The public examples demonstrate the intended workflow. They are not customer outcomes, measured time savings or a clinical accuracy benchmark.
Explore the fictional RD-204 schedule, specialist discussion, source limitation and draft decision. Check the arithmetic and follow the record.
Try the study challenge →Can your team complete the agreed task, identify relevant issues, challenge incorrect findings and hand over a usable record? Measure time spent preparing, reviewing and resolving comments, as well as the quality of the result.
See the evaluation plan →Explore with your team
Explore a decision that matters to your study, the evidence behind it and the perspectives needed to move it forward.