TCRLAS v2.0 · WORKING DRAFT
Commercial viability. Evidence before decisions. Record a five-dimension CVA profile with evidence. Explore and verify maturity in the separate milestone assessment. Scores never approve an investment or launch.
TCRLAS overview TCRLAS guide Methodology library Acronyms & shorthand CVA rubric Assessment scopes Nine-milestone assessment Human milestone review CVA assessment HSE assessment CDA guide Launch guide Domain comparison Private by design: this browser-only draft is held in memory. Refreshing, leaving this page or closing it loses unsaved work. Export your JSON for safekeeping and import it to continue. No automatic storage, accounts, database or submission. Do not enter patient-identifiable information or confidential business details. JSON exports are unencrypted.
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Independent maturity record Milestone: NE — not assessed.
CVA and HSE never assign maturity. Export this record, open the milestone tool, and import it there to review maturity. Import its exported record here to continue. All profiles and evidence remain in the complete JSON.
Open independent milestone assessment → Commercial Viability Assessment (CVA) Scores are ordinal evidence anchors, not probabilities. NE is unassessed. A zero needs an adverse evidence rationale. HSE N/A requires a documented applicability reason, reviewer and date; it is never converted into a score.
M — Market Opportunity Is an economically meaningful and accessible customer market worth pursuing?
M assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 M score slider
Inspect all M evidence anchors (0–6) 0: No credible customer, need or viable accessible market identified; or fundamental demand proposition disproven.1: Plausible need and potential users/buyers hypothesized, without meaningful independent evidence.2: Customer types, alternatives and approximate addressable market investigated with preliminary external information.3: Specific reachable segment, purchasing pathway, demand and willingness-to-pay assumptions credibly documented.4: Independent customers or purchasing authorities substantiate demand and feasible access to initial market.5: Representative external demand and concrete procurement or commercial signals support market depth and acquisition assumptions.6: Repeatable demand in a representative segment with credible continuing access and growth potential demonstrated.M evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
C — Competitive Advantage Why would the buyer prefer the offering, and can the advantage persist?
C assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 C score slider
Inspect all C evidence anchors (0–6) 0: No credible customer-relevant difference or insurmountable known use-rights issue.1: Advantage asserted without meaningful comparison.2: Preliminary comparisons of performance, cost, usability, rights or access identify plausible advantage.3: Documented material advantage, alternatives and key imitation/rights risks with credible competitive strategy.4: Independent testing, buyers or market evidence supports advantage, and protection path is credible.5: Advantage externally supported under realistic competitive comparison; important imitation/rights issues managed.6: Durable advantage demonstrated through continued customer preference, economics, know-how, rights or switching barriers.C evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
E — Commercial Economics Does further investment have a credible path to sufficient economic value?
E assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 E score slider
Inspect all E evidence anchors (0–6) 0: No viable economics or demonstrably untenable costs with no plausible remedy.1: Revenue and cost hypotheses only.2: Preliminary prices, product/service delivery costs, capital needs and sources estimated.3: Documented margin, cash requirement and break-even model with credible assumptions and sensitivities.4: Important pricing and costs externally substantiated; plausible economics demonstrated for proposed route.5: Strong evidence of attractive unit economics and realistic capital needs resilient to material scenarios.6: Sustained or repeatably validated economics under relevant conditions with credible financing and growth path.E evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
X — Execution Capability Can accountable parties deliver the specified next milestone?
X assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 X score slider
Inspect all X evidence anchors (0–6) 0: No feasible execution route; indispensable capabilities/resources inaccessible.1: Possible team, partners, licensing path or resources merely identified.2: Initial roles, budgets, dependencies and delivery partners identified.3: Milestone-specific owners, budget, schedule, dependencies and potential partners credibly documented.4: Key owners, partners and resources supported by verifiable commitments for next milestone.5: Proven delivery capability and adequate available/accessible resources with contingency for major milestone.6: Repeatable resilient execution through capable organization/contracted partners without single-point dependence.X evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
R — Risk Manageability Are risks identified and controlled sufficiently for the proposed action?
R assessment NE — not evaluated 0 / 6 1 / 6 2 / 6 3 / 6 4 / 6 5 / 6 6 / 6 R score slider
Inspect all R evidence anchors (0–6) 0: Established fatal unmanageable risk for proposed action.1: Material uncertainty largely unexamined; no credible controls.2: Key legal, safety, technical, financial, operational and commercial uncertainties preliminarily registered.3: Dated risk register with consequence, uncertainty, owner, mitigation and resolution evidence milestones.4: Major risks have supported mitigations, contingencies and clear validation milestones.5: Major exposures controlled or reduced; residual risk acceptable for defined next activity and triggers documented.6: Controls demonstrably effective under relevant adverse scenarios and sustained monitoring.R evidence, confidence and rationale Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Critical blocker register Record which activity a blocker affects. A restriction on launch does not by itself prohibit lawful preparatory research.
Add blocker Commercial Launch Decision Separate named human review for a defined offering, scope and jurisdiction. GO is never produced by scores or checklist completion. CONDITIONAL refers only to activities already permitted.
Read the decision guide → Applicable launch requirements Scope being reviewed Jurisdiction: not specified Intended use: not specified Claims: not specified
Qualified reviewers determine each requirement’s applicability for this exact scope. Changing scope clears previous requirement reviews.
These prompts are a working framework, not an exhaustive legal checklist. Review each against intended use, claims and jurisdiction with qualified people. Unreviewed or unresolved mandatory requirements prevent recording GO/CONDITIONAL.
Offering, intended use, claims, users, jurisdiction and launch scope — unreviewed Offering, intended use, claims, users, jurisdiction and launch scope status unreviewed unresolved verified not_applicable Offering, intended use, claims, users, jurisdiction and launch scope evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Applicable legal permissions and qualified review — unreviewed Applicable legal permissions and qualified review status unreviewed unresolved verified not_applicable Applicable legal permissions and qualified review evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Evidence supports claims and intended benefits — unreviewed Evidence supports claims and intended benefits status unreviewed unresolved verified not_applicable Evidence supports claims and intended benefits evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Delivery, accountable owners, continuity, support and incident controls — unreviewed Delivery, accountable owners, continuity, support and incident controls status unreviewed unresolved verified not_applicable Delivery, accountable owners, continuity, support and incident controls evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Buyer/payment route, pricing, costs and available capital — unreviewed Buyer/payment route, pricing, costs and available capital status unreviewed unresolved verified not_applicable Buyer/payment route, pricing, costs and available capital evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Named decision authority and documented review — unreviewed Named decision authority and documented review status unreviewed unresolved verified not_applicable Named decision authority and documented review evidence Source / reference (not uploaded or fetched) Evidence date Evidence reviewer Verification status unreviewed claimed verified contradicted Assessor confidence unassessed low medium high Rationale / supporting notes Contrary evidence / uncertainty Next evidence needed N/A applicability reason (when relevant)
Human launch decision UNDECIDED GO CONDITIONAL HOLD NO_GO Decision reviewer Decision review date Decision authority / capacity Decision rationale and alternatives Accountable action owner Permitted scope / limits Monitoring, adverse-event / stop triggers Next review date
Unassessed decision: no authorization recorded.
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CVA five-axis profile CVA five-axis profile Market: not evaluated; Advantage: not evaluated; Economics: not evaluated; Execution: not evaluated; Risk: not evaluated. Missing values are not plotted as zero. Market NE Advantage NE Economics NE Execution NE Risk NE Incomplete numeric profile: no filled polygon. NE = not evaluated; N/A = documented non-applicability; zero is an actual evaluated score. Neither chart determines TCRLAS or authorizes a decision.
M: NEC: NEE: NEX: NER: NEWorking methodology, not externally validated. No numerical cutoff grants investment, clinical, regulatory or launch authorization. A qualified human must review the proposed action and applicable obligations.
Read the methodology PDFs →