You retain a specialist. The platform is included.
Every engagement is calibrated against real inspection outcomes — not a self-referential score. Choose the surface that fits your stage.
oPoS Platform
Self-serve software you can start using today.
The full oPoS platform for power users.
- All 14 Killer Factors
- VeriAbyss™ Consistency Review
- Dynamic Weighting
- Trial Search & Alerts
- Lead Pipeline CRM
- Excel Import
- Unlimited Projects
- Priority Support
Calibration Engagements
You retain a specialist who knows what the output means. Every engagement is scoped to your protocol and calibrated against real inspection outcomes — not a tool grading its own homework.
Bring us your tool's score. We tell you what an inspector would actually find.
- Independent review of your existing assessment output
- Blind-spot detection across 20 ICH E6(R3) dimensions
- Calibration against real inspection outcome patterns
- Gap-by-gap comparison: your score vs. inspector reality
- Written calibration report with prioritized corrections
- 1-on-1 walkthrough with a senior specialist
ICH E6(R3) Readiness & Implementation
The revised GCP guideline introduces Quality by Design, proportionality, and expanded data governance. EU/EMA effective 23 July 2025 (already passed); US/FDA no formal date yet (align now); Annex 2 effective 15 January 2027. We audit where you stand and help you implement the changes.
A structured readiness review of your quality system against the new GCP standard.
- Current-state review of SOPs & quality system
- Gap analysis vs. ICH E6(R3) principles & Annex 1
- Quality-by-Design & critical-to-quality mapping
- Risk-based monitoring & oversight review
- Data governance check (Sections 3.16 & 4)
- Annex 2 readiness audit (CSV, audit trails, data lifecycle, AI/ML)
- EU vs US implementation timeline guidance
- Prioritized remediation roadmap with Annex 2 Jan 2027 targets
- Written findings report
Guided end-to-end implementation of the new GCP standard.
- Everything in the Gap Assessment
- Dedicated specialist (4–6 weeks)
- SOP & process redesign
- Risk-based quality management framework
- Computerized system validation (CSV/GAMP 5)
- Audit trail review SOPs & data lifecycle governance
- Annex 2 data governance implementation (Jan 2027 ready)
- Team training & rollout
- Inspection-readiness preparation
- Ongoing calibration through go-live
Clinical Operations Intelligence Readiness
Before investing in an analytics pilot, find out whether your data, workflows, and sponsor governance are ready. Start free, then engage a structured sprint to close the gaps.
A 2–3 week structured assessment to close gaps before a pilot.
The Complete Package
Everything BleuConsult offers — all advisory, compliance, and readiness services bundled into one engagement at a significant discount. For organizations that want the full transformation.
Everything BleuConsult offers — calibration, readiness, Resource Store implementation tools, and decision-evidence support in one package.
- E6(R3) Readiness Calibrated ($9,500 value)
- E6(R3) Inspection-Ready in 90 Days ($28,000 value)
- Remediation Roadmap add-on ($4,500 value)
- Intelligence Readiness Sprint ($14,500 value)
- Full Diagnostic advisory engagement ($35,000 value)
- 1 year oPoS Premium platform ($2,388 value)
- Resource Store — all 3 collections included
- Dedicated senior specialist through entire engagement
- Priority support & quarterly compliance check-ins
- Regulatory update alerts (FDA, EMA, ICH) for 1 year
- Decision Evidence Record setup to tie findings, actions, and resources together
SOP, Form & Tracker Collections
Buy individual SOPs, forms-and-trackers packs, or full quality-system suites. All collections are ICH E6(R3) aligned and delivered as editable Word + Excel source. Browse full contents and purchase on the Resource Store.
ICH E6(R3) Implementation Guide
10-chapter plain-language guide with Appendix B protocol template and optional advisory session.
ICH E6(R3) Gap Self-Assessment
20-dimension self-scoring workbook with optional calibrated score and remediation roadmap.
Regulatory Change Management Playbook
Build an auto-triage regulatory monitoring loop — the process design consultancies guard.
Clinical Data Management Suite
28 SOPs, 64 forms, 15 tracker workbooks — sponsor-side CDM quality system.
Clinical Operations Suite
36 SOPs, 52 forms, 14 tracker workbooks — sponsor-side ClinOps quality system.
Clinical Programming Suite
33 SOPs, 49 forms, 16 tracker workbooks — sponsor-side programming QMS.
Premium Subscription
Billed monthly at $199/month. Cancel anytime. All platform features included with no hidden fees.
Calibration Engagements
Operational Gut-Check ($500), Protocol Cleared for Execution ($3,500), and Critical Stretch Covered ($6,500) are fixed-fee engagements. The Inspection-Ready Diagnostic starts at $35,000 and is scoped to your protocol. E6(R3) Compliance Calibrated ($9,500) is a fixed-fee audit; E6(R3) Inspection-Ready in 90 Days starts at $28,000 and is scoped to your organization. The Remediation Roadmap add-on is $4,500 (one-time). The Clinical Operations Intelligence Readiness Assessment is free; the Readiness Sprint ($14,500) is a fixed-fee 2–3 week engagement. The Complete Clinical Operations Excellence bundle is $45,000 (one-time) — a $48,888 savings vs. purchasing services individually. Contact sales for a quote.
Resource Store Collections
SOP, form, and tracker collections are purchased individually on the Resource Store. Single SOPs start at $249; full suites range from $6,500 to $9,500; suite-plus-advisory tiers range up to $16,500. Teaching guides and playbooks start at $149 (Implementation Guide) and $399 (Regulatory Change Management). All collections are ICH E6(R3) aligned and delivered as editable Word + Excel source.
Secure Payments
Platform subscriptions are processed securely through Stripe. Advisory engagements are invoiced directly. We never store your payment information.
Questions? Contact our sales team at sales@bleuconsult.org
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.
