Build and validate the program.
Turn sponsor requirements into controlled questions, deterministic rules, study deployments, tests, approvals, and release evidence.
- Portfolio
- Designer
- Rules
- Study
For pharmaceutical sponsors and research partners
From approved criteria to controlled consumer access.
ClearGate gives pharmaceutical sponsors a controlled way to translate product-specific criteria into deterministic qualification, validated releases, retailer authorization, operational monitoring, and traceable evidence.
ClearGate Sponsor WorkspaceRelease 1.1.0
Ready for controlled releaseCandidate manifest · CR-VRX-0007 · generated 22 Aug 2026, 14:32 ET
Validation148 / 148tests passed
Requirements42 / 42fully traced
Approvals4 / 4signed
Open blockers0release blockers
Traceability coverage
Requirement-to-test lineage for this release candidate
RequirementRuleValidationState
REQ-VRX-014Condition Alpha exclusionVRX-003TEST-083 Passed
REQ-VRX-021Incomplete input safe stateVRX-011TEST-112 Passed
REQ-VRX-026Authorization expiry policyVRX-018TEST-127 Passed
REQREQ-VRX-014→QUESTIONQ-014→RULEVRX-003→TESTTEST-083→RESULTPASS
The operating problem
The assessment is only the visible step.
Some technology-assisted nonprescription programs require more than labeling alone. Once an additional digital condition becomes part of the access pathway, the sponsor needs more than a questionnaire.
Product-specific criteria must become reproducible software behavior, move through controlled validation and release, and remain operable and reconstructable after launch.
- Product-specific
- Each program keeps its own sponsor-approved questions, rules, messages, measurements, authorization policy, and release history.
- Deterministic
- Identical inputs under the same approved version produce the same result. Generative AI does not make the qualification decision.
- Operational
- Study, runtime, retailer verification, monitoring, vigilance, CAPA, and evidence stay connected to the same controlled lineage.
Product proof
Every material decision remains reconstructable.
ClearGate connects sponsor intent, configuration, validation, approval, release, assessment, decision, authorization, and downstream verification in one operating history.
Decision lineageAUTH-VRX-829401
- 01AssessmentCompleted 15:04:12 ET
ASM-9B82F4C1 - 02Deterministic decisionRule set VRX 1.1.0
DEC-382910 - 03Signed authorizationMinimal permitted metadata
AUTH-VRX-829401 - 04Retail verificationVerified and redeemed
BWPG-001
Synthetic demonstration data. No real drug, patient, clinical criteria, or transaction is represented.
One controlled model from development to commercial access.
The platform spans three buyer-facing operating domains without forcing sponsors to stitch together disconnected point solutions.
Run access across channels.
Deliver the approved consumer experience, issue minimal signed authorization, and connect physical and ecommerce retail environments.
- Runtime
- Access
- Integrate
Monitor, investigate, reconstruct.
Detect failures, investigate impact, manage corrective action and controlled change, and preserve the evidence behind every material state.
- Vigilance
- Evidence
- Change control
- Audit & quality
Two views of one system
A short consumer flow. A complete operating record.
The consumer sees only the approved qualification experience. ClearGate retains the controlled lineage beneath every decision and authorization.
Consumer experienceControlled system record
- Answer approved questionsAssessment created against release 1.1.0
- Receive approved resultDecision stored with rule and reason codes
- Present authorizationSigned, time-limited authorization issued
- Complete transactionVerification and redemption appended to lineage
Designed for when things go wrong
Failure handling is part of the product.
Signals become investigations, affected decisions can be identified, corrective action stays linked to evidence, and uncertainty never becomes qualification.
Open investigation
CASE-ACNU-0004Severity 2 · Synthetic demoSignalMalformed lab units14:02
ImpactAssessments identified14:06
Root causeAdapter validation gap15:14
CAPACAPA-0012 opened15:37
Controlled changeCorrected release validated18:22
No reliable decision means no authorization.
Released configuration cannot be silently rewritten.
Authors, reviewers, approvers, operators, and retailers remain distinct.
Retailers receive only what the approved transaction requires.
Reference security baseline: tenant isolation, MFA and role-based access, encryption in transit and at rest, centralized secrets management, API authentication, rate limiting, input validation, and auditable administrative activity.
The sponsor keeps clinical control.
ClearGate operationalizes sponsor-defined pharmaceutical programs without becoming the prescriber, pharmacy, or independent regulatory decision-maker. Each party stays inside an explicit responsibility boundary.
Pharmaceutical sponsor
- Clinical criteria and regulatory strategy
- Approved consumer content
- Drug safety and sponsor obligations
- Program oversight and accountability
ClearGate
- Controlled configuration and deterministic execution
- Validation evidence and release controls
- Access control and security infrastructure
- Monitoring, incident handling, and integration
Retailer
- Transaction processing and inventory
- Authorization verification
- Retail-specific consumer obligations
- Authorization enforcement within its channel
Bring the program.
ClearGate brings the infrastructure.
Bring a candidate asset, active switch program, or study requirement. Start with feasibility or carry the same controlled model into study, commercial runtime, retailer verification, and vigilance.
Discuss a sponsor program contact@cleargateaccess.com