Choose the support your next clinical milestone needs.
Start with a focused review, scope the implementation work, and add ongoing oversight when needed. Use oPoS separately or include it explicitly in your engagement agreement. These USD rates apply to new clients. Existing signed agreements remain unchanged.
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
Each engagement starts with a written scope covering inputs, deliverables, review rounds, specialist availability and acceptance. Findings support your decisions; they do not guarantee inspection outcomes.
A specialist review of one existing assessment and its supporting evidence.
- Up to 20 total specialist hours; evidence sample agreed before work starts
- Review of assumptions, evidence gaps and priorities across applicable E6(R3) dimensions
- Written findings with prioritized corrections
- One senior-specialist walkthrough and one clarification round
- Not a regulatory inspection, certification or prediction of inspection findings
An operational review of one protocol and one version.
A bounded two-week support window for an agreed operational priority.
- Up to 20 total specialist hours across the two-week window
- Calls, preparation, document review, email and delivery all count toward the limit
- Agreed operational review, implementation guidance and risk-mitigation actions
- Written action summary and handover
- Not full-time, unlimited or on-call coverage; extra work requires written scope approval
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 in the EU, where applicable. We audit where you stand and help you implement the changes.
An evidence-based review for one sponsor and one study.
- Up to 20 documents and 300 total pages, whichever limit is reached first
- Up to four stakeholder interviews
- Review against applicable E6(R3) principles, Annex 1 and trial-specific Annex 2 considerations
- Quality-by-Design, oversight and data-governance gap matrix
- Prioritized remediation roadmap and written findings
- One findings readout and one clarification round
- Remediation execution and additional studies are scoped separately
A defined first implementation phase, not an unlimited quality-system transformation.
- Up to 100 total specialist hours, including any agreed current-state assessment
- Up to six priority SOP or workflow revisions, selected in the written work plan
- Named process owners, risk-based governance and evidence requirements
- One team training session, one acceptance cycle and documented handover
- Calls, preparation, review, email and delivery count toward the agreed hours
- Validation execution, extra studies, ongoing oversight and further phases quoted separately
- No guaranteed inspection outcome or fixed inspection-readiness date
Remediation Roadmap Add-on — $4,500 one-time
For an existing assessment that does not already include the requested plan, scope a detailed remediation roadmap with owners, target dates and an execution sequence. The prioritized roadmap already included in our Gap Assessment is not charged again. Scope and acceptance are agreed before work starts.
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.
One use case assessed within a two-to-three-week delivery window.
- Up to 40 total specialist hours, including meetings, preparation, review and email
- One scoped use case and decision-pathway design
- Data readiness and governance review
- Gap-remediation plan and pilot success criteria
- Written readiness report, roadmap and go/no-go recommendation
- Pilot delivery, software builds and validation execution are not included
Phased Implementation Program
Combine only the workstreams your team needs. Agree the study scope, delivery capacity, dependencies and milestone fees before work begins.
Only the workstreams your study needs, with one agreed scope and no duplicate assessment charges.
Final fee follows the agreed scope. Separate services are not automatically included.
- Up to 120 total agreed specialist hours across the defined program
- Named workstreams, document volumes, review rounds and milestones in the proposal
- Current-state assessment reused across workstreams rather than billed twice
- Decision pathways, evidence requirements, acceptance review and handover
- Meetings, preparation, document review, email and delivery all count toward the limit
- Platform access included only where specified in the agreement
- Resource templates included only after release checks pass and where explicitly agreed
- Validation execution, additional studies, ongoing support and extra hours quoted separately
Fractional Clinical Operations Leadership
Reserve defined senior leadership capacity, not unlimited availability. Agree the named specialist, delegated authority, deliverables, study and vendor scope, cadence and response window before work starts. Sponsor, medical and quality-system approvals remain with the authorized role holders.
Reserved senior sponsor-side leadership capacity for a defined remit.
- Up to 32 total specialist hours per month
- Three-month initial term
- Written decision authority, deliverables, vendor scope and meeting cadence
- Calls, preparation, review, email and delivery included in the hour limit
- Response windows agreed in writing; no unlimited or round-the-clock availability
- Additional capacity requires a separate written agreement
More senior leadership capacity for a broader agreed operating remit.
- Up to 64 total specialist hours per month
- Three-month initial term
- Written decision authority, deliverables, vendor scope and meeting cadence
- Calls, preparation, review, email and delivery included in the hour limit
- Response windows agreed in writing; no unlimited or round-the-clock availability
- Additional capacity requires a separate written agreement
SOP, Form & Tracker Collections
Preview editable SOP, form and tracker collections. Resource Store checkout remains paused while content, usability and protected delivery checks are completed. Displayed prices are informational; templates require organizational adaptation and approval before operational use.
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, 30 forms and one integrated workbook with 15 operational tracker tabs. Customer release pending.
Clinical Operations Suite
36 SOPs, 51 forms and one integrated workbook with 14 operational tracker tabs. Customer release pending.
Clinical Programming Suite
33 SOPs, 49 forms and one integrated workbook with 16 operational tracker tabs. Customer release pending.
Premium Subscription
Billed monthly at $199/month. Cancel anytime. All platform features included with no hidden fees.
Calibration Engagements
New-client fees are $500 for the 45-minute Operational Gut-Check, $4,500 for one Protocol Operational Review, $7,500 for up to 20 hours of Two-Week Advisory Support, $7,500 for a scoped Inspection Calibration Review, $12,500 for the E6(R3) Gap Assessment and $14,500 for the Readiness Sprint. Implementation starts at $35,000 for the defined initial phase; the phased program starts at $45,000. Fractional leadership is $12,500/month for up to 32 hours or $22,000/month for up to 64 hours, with a three-month initial term. Interim full-time leadership is $45,000/month, scoped by written agreement. All service limits above apply. Overlapping assessments are scoped once, not billed twice. Existing signed agreements, invoices and subscriptions are unchanged.
Resource Store Collections
Resource Store checkout is paused pending quality and protected-delivery acceptance. Displayed catalog prices are informational. 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). Future released collections will provide editable Word and Excel templates requiring organizational adaptation and approval.
Secure Payments
Platform subscriptions use Stripe. New advisory and fractional engagements require an agreed written scope and direct invoice; selecting a service or requesting a meeting does not authorize a charge. New consulting requests are not routed through legacy diagnostic checkout. Existing signed agreements remain unchanged.
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.
