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From the interactive platform tour to our full suite of calibration, compliance, and readiness services — see it all here.
Explore oPoS, the clinical trial risk assessment product by BleuConsult
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Recent Activity
A single view of every active review, its risk level, and what needs attention next.
From request to clarity in three steps.
No lengthy onboarding. No commitment required before the first conversation.
Request the Introductory Consult
Submit a short request describing your team, stage, and the operational concern you want to examine. BleuConsult will confirm and schedule the session.
Focused Strategy Conversation
A 60-minute founder-level conversation reviewing your concern across clinical operations, vendor oversight, data readiness, documentation, regulatory-facing workflows, or AI workflow governance.
Next-Step Recommendations
Clear identification of early risks, blind spots, and decision gaps, with practical recommendations on what to address and whether deeper support is needed.
How BleuConsult Supports Early Teams
Clinical Operations Calibration
Operational planning, ownership clarity, and execution-risk review for teams building their first or second trial.
Protocol Risk Review (oPoS)
The 14 Killer Factors framework — structured scoring across protocol, vendor, data, site, and execution dimensions before you commit.
Vendor & CRO Oversight
Clarify responsibilities, handoffs, escalation paths, and accountability so the sponsor side stays in control.
Data Readiness Review
Assess whether data-management planning, collection, and documentation are aligned with execution reality.
ICH E6(R3) Gap Assessment
Audit your quality system against the revised GCP guideline (Principles and Annex 1 effective in the EU on 23 July 2025; confirm local applicability) with a prioritized remediation roadmap.
AI Workflow Governance
Governance support for teams adding AI, automation, or analytics before the underlying workflow is fully mapped and controlled.
A focused first conversation for early teams that need a sharper view of the operational risks forming underneath the plan.
Early biotech companies are often asked to make sponsor-level decisions before they have sponsor-level infrastructure. The science may be strong. The platform may be promising. The team may have advisors, vendors, investors, and a development plan. But the operational questions arrive early.
BleuConsult's Introductory Founder Consult is designed for that stage.
This consult helps founders identify where operational risk is forming underneath the plan — before it becomes expensive.
Strong science needs reliable clinical operations.
Build processes that can keep pace with growth.
You might already feel it:
BleuConsult helps you see those risks before they become expensive – start with oPoS software and practical Resource Store templates.
Clinical Operations Intelligence & Pilot Readiness
Predictive and prescriptive analytics can help biotech teams see risk earlier — but only when the operational question is clear, the data are usable, and the sponsor has a decision pathway for acting on the insight. BleuConsult works in that gap.
The problem is not always the analytics platform.
Often, the company has not clearly defined the clinical operations question, identified the right data sources, assessed whether the data are usable, or built the sponsor-side process needed to act on the insight.
BleuConsult works in that gap.
Use-Case Framing
Define the right operational question before investing in an analytics pilot — tied to a real decision, not a vague interest in AI.
- Trial drift early-warning
- CRO oversight risk
- Site activation delays
- Enrollment friction
- Escalation bottlenecks
Data Readiness Assessment
Evaluate whether your data can actually support a predictive model — completeness, quality, curation gaps, and operational relevance.
- Data source inventory
- Quality & completeness review
- Curation needs mapping
- Platform fit assessment
Sponsor-Side Risk Mapping
Map clinical operations risks that may not be visible in a standard dashboard — across CRO, vendor, site, data, and escalation layers.
- CRO & vendor performance risk
- Protocol feasibility gaps
- Inspection readiness
- SOP alignment
Pilot Readiness Sprint
A short 2–3 week assessment before you commit to a full analytics engagement. Determine scope, data fit, success criteria, and go/no-go.
- Use-case validation
- Data source inventory
- Success criteria definition
- Go/no-go recommendation
Operational Translation
Connect analytics outputs to sponsor-side action — who owns the signal, when it escalates, what governance reviews it, what triggers change.
- Decision pathway design
- Escalation framework
- SOP & process adjustment
- Signal tracking over time
Analytics Partner Bridge
BleuConsult owns the clinical operations workstream while your analytics partner owns the modeling — a co-delivery structure built for lean teams.
- Joint pilot scoping
- Shared deliverables
- Risk map + model handoff
- Decision governance
Ready to assess your intelligence readiness?
Start with the free 10-dimension self-assessment, or engage the structured 2–3 week Readiness Sprint to close the gaps before a pilot. Strong analytics needs a decision pathway — BleuConsult builds it.
Best suited for
ICH E6(R3) Gap Assessment & Implementation
The revised GCP guideline introduces Quality by Design, proportionality, and expanded data governance. The EU/EMA effective date was 23 July 2025 (E6(R2) ceased 22 July 2025) — EU-regulated trials must already be compliant. The US/FDA published final guidance in September 2025 but has not set a formal compliance date — US organizations should align now. Annex 2 (non-traditional interventional trials) takes effect 15 January 2027 in the EU. We audit where you stand and help you reach inspection readiness.
Two ways to get E6(R3) ready
Start with a structured Gap Assessment of your quality system, or go end-to-end with a guided 90-day Implementation program — both scoped to your organization and aligned to Annex 2 (Jan 2027).
Remediation Roadmap add-on. Already have a gap assessment? Add a detailed, prioritized remediation roadmap with Annex 2 (Jan 2027) targets and antidotes for every finding. See pricing for details.
ICH E6(R3) Basics Guide
A foundational overview of the revised GCP guideline — what changed, the EU/US compliance timeline, the guideline structure, and a basic readiness checklist.
What's included: Key changes from E6(R2), compliance timeline (EU vs US), Annex overview, basic readiness checklist. What's NOT included: The full 20-dimension gap assessment, remediation roadmap, and implementation templates — those are paid services.
Your Client Portal
Track your protocol review, download your calibration summary, manage invoices, and access Astrid AI — all in one place.
- Track your protocol review status in real time
- Download your AI-generated calibration summary once delivered
- Receive automated updates at each pipeline stage
- Manage invoices and payment directly
- Access Astrid AI for ongoing clinical operations questions
BleuConsult Client Portal
Secure access for active clients
Request an Introductory Founder Consult
If your team is early, moving fast, and trying to understand what operational risks may be forming underneath the plan, request an Introductory Founder Consult with BleuConsult.
Compliance & Transparency
oPoS is an advisory decision-support tool designed to assist clinical trial planning. It does not replace professional regulatory judgment. The methodology is designed to support ICH E6(R3)-aligned assessment, sponsor oversight documentation, and decision evidence. The platform may process business contact information, uploaded protocol materials, and other user-provided content. Do not upload PHI unless appropriate agreements and safeguards are in place. VeriAbyss™ provides AI-assisted consistency review; outputs remain advisory until qualified human review.
© 2026 BleuConsult. All methodologies, frameworks, assessment logic, and library materials are the proprietary intellectual property of BleuConsult. All rights reserved.
All assessments are for informational purposes only.
Compliance & Transparency
oPoS is an advisory decision-support tool designed to assist clinical trial planning. It does not replace professional regulatory judgment. The methodology is designed to support ICH E6(R3)-aligned assessment, sponsor oversight documentation, and decision evidence. The platform may process business contact information, uploaded protocol materials, and other user-provided content. Do not upload PHI unless appropriate agreements and safeguards are in place. VeriAbyss™ provides AI-assisted consistency review; outputs remain advisory until qualified human review.
© 2026 BleuConsult. All methodologies, frameworks, assessment logic, and library materials are the proprietary intellectual property of BleuConsult. All rights reserved.
All assessments are for informational purposes only.
