CLINIQ — Clinical Intelligence for Integrity & Quality
CLINIQ
Selected for GCC REACH Stage 2

Smarter Trial Execution. Faster Breakthroughs.

CLINIQ helps high-risk clinical trial teams handle workflow exceptions using SOP- and protocol-based guidance.

Cited guidance when supported. Required escalation when it is not.

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Research-stage prototype
CLINIQ Workflow BlueprintVerified
Workflow ExceptionOut-of-window eventSOP / ProtocolApproved source retrievedCitation CheckCited GuidanceStepwise · sourcedRequired EscalationPI · QA · SponsorAudit-Ready RecordDecision · citation · timestamp
The Problem

Small Exceptions Can Threaten Critical Trial Data

Missed toxicity checks

Late or missing CRS / ICANS safety checks in time-critical windows.

Out-of-window specimens

Time-sensitive biomarker collections that fall outside protocol.

Chain-of-custody gaps

Temperature excursions, labelling errors, and handoff failures.

Unclear deviation / CAPA escalation

Ambiguity on what to escalate, when, and to whom.

Trial teams need support at the moment risk occurs—not only documentation after the event.

How It Works

Evidence or Escalation. Nothing in Between.

Every CLINIQ response is grounded in approved source text—or stops and routes to the right authority.

Step 01

Workflow exception occurs

An event falls outside expected protocol.

Step 02

CLINIQ retrieves approved SOP / protocol

Pulls language from governed source documents.

Step 03

Checks whether the source supports action

Citation-gated decision logic.

4A · Supported

Returns cited, stepwise guidance

  • Source quote and reference
  • Sequenced next actions
  • Confidence visible to the user
4B · Unclear

Stops and escalates

  • Routes to PI, QA, pharmacy, monitor
  • Captures rationale for escalation
  • No fabricated guidance, ever

Creates an audit-ready record

Decision, citation, escalation path, and timestamp—captured automatically.

No clinical judgment. No unsupported improvisation. No silent failure.

Live Prototype

A research-stage prototype, available on request.

cliniq-trial · secured research prototype
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QR code linking to CLINIQ prototype

CLINIQ is a secured research-stage prototype demonstrating citation-gated guidance and escalation behavior using sample SOPs.

SOP-anchored guidance
Responses tied to approved source documents.
Refusal & escalation boundaries
Stops cleanly when evidence is insufficient.
Structured audit trail
Captures decisions for review and traceability.
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Founder

Built From the Operational Problem

Mana Kashuk, Founder of CLINIQ

Mana Kashuk

MSc, MBA, PhD Candidate

Founder

Mana's work spans translational science, clinical research operations, governed AI workflows, and commercialization. CLINIQ was developed to address a specific gap in high-risk trial execution: helping teams find supported next steps—or escalate when the approved source is unclear.

Pharmaceutical SciencesClinical Research OperationsGoverned Workflow DesignGCC REACH Stage 2
Current Stage

From Proof of Concept to Validated Product

Selected for GCC REACH Stage 2 Strategic Advisory Team-assisted Product Commercialization Plan development.

  • Milestone 01
    GCC REACH Stage 2
  • Milestone 02
    Customer discovery
  • Milestone 03
    Workflow & swimlane mapping
  • Milestone 04
    Retrospective / simulated validation
  • Milestone 05
    Usability testing
  • Milestone 06
    Security & integration planning
  • Milestone 07
    SBIR / STTR readiness
Validation

What CLINIQ Must Prove

Before any live workflow pilot, CLINIQ must demonstrate safe, traceable, and operationally useful behavior through controlled simulation and expert review.

M-01
Citation accuracy
Are responses grounded in the cited source?
M-02
Unsafe-instruction rate
Frequency of unsupported or risky outputs.
M-03
Escalation correctness
Right path, right authority, right rationale.
M-04
Deviation-risk detection
Catching exceptions where action is required.
M-05
Documentation completeness
Full record of decisions and citations.
M-06
Time to correct action
Speed from exception to validated next step.
Designed For

Teams operating where precision matters most.

Designed around the needs of teams operating in high-risk clinical trial workflows.

Clinical trial operations teams
CRCs and research nurses
QA and regulatory teams
CTU, CRO, and sponsor operations leaders
Contact

Let's Improve How High-Risk Trials Handle the Unexpected.

For advisory discussions, customer discovery interviews, prototype review, or future pilot exploration.

Request Prototype Access Contact CLINIQ
hello@cliniqtrial.com