WHO WE SERVE / LARGE PHARMACEUTICALS

RBQM Built for
Enterprise Pharma Scale

Global pharmaceutical companies run complex pipelines across dozens of studies, multiple CRO partners, and varied EDC platforms. CluePoints gives enterprise pharma the RBQM and clinical data oversight platform they need to move beyond disconnected tools, delivering portfolio-wide risk visibility, consistent quality governance, and the inspection-ready evidence trail that regulators expect under ICH E6(R3).

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Top 20

global pharma companies use CluePoints

500+

enterprise studies actively monitored

40%

reduction in
monitoring costs

3x

faster risk signal identification

Challenges We Solve for Large Pharma

Enterprise pharma faces quality oversight challenges that generic monitoring tools were never designed to handle. CluePoints is purpose-built for this complexity.

Fragmented Portfolio Oversight

Managing quality across dozens of simultaneous studies, multiple CRO partners, and varied EDC platforms creates blind spots. CluePoints unifies risk signals across your entire portfolio in one environment, so you see what matters before regulators do.

Inspection Exposure You Can’t See

Traditional on-site monitoring and KRI dashboards catch individual data errors—not the systemic patterns that drive inspection findings. CluePoints’ central statistical monitoring applies the same analytical methods regulators use, giving you a preview of your inspection risk before it materializes.

ICH E6(R3) Compliance at Scale

ICH E6(R3) requires documented, proportionate, end-to-end RBQM across every study. CluePoints captures the complete evidence thread from CtQ mapping through signal resolution, automatically and at enterprise scale, without retrospective documentation effort.

CRO Oversight Without Duplication

Large pharma Sponsors need independent visibility into quality risk across CRO partners. CluePoints acts as the Sponsor’s independent oversight layer, providing objective, data-driven performance visibility across every CRO partner without duplicating their process or disrupting established workflows.

The Full CluePoints Platform

Move beyond disconnected tools toward a unified ecosystem for RBQM, clinical data review, and quality oversight, purpose-built for enterprise pharma scale.

Risk-Based Quality Management (RBQM)

Portfolio-scale RBQM combining its Central Monitoring Platform (CMP) for cross-domain risk detection and Site Profile & Oversight Tool (SPOT) for site-level prioritization and action. Full ICH E6(R3)-aligned traceability from risk identification to documented resolution.

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Intelligent Medical
Coding (IMC)

Enterprise-grade coding consistency across studies, programs, and time, retaining institutional knowledge at scale.

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Medical & Safety
Review (MSR)

Structured, audit-ready periodic safety review with validated two-way EDC connectivity and portfolio reuse economics.

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Intelligent Query
Detection (IQD)

Free up data management capacity with 80%+ precision AI that helps your team avoid investigating false positives.

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Consulting
& Services

RBQM framework design, CtQ mapping, and enterprise change management from specialists who have done it before.

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“CluePoints gives us access to view data in ways we otherwise can't and the trends coming out of it are giving us opportunity to research and investigate”

Global Senior Study Lead - Top 10 Pharmaceutical Company

"The robust SMART engine and supporting features help achieve our Central Monitoring objectives effectively and efficiently."

Associate Director, RBQM Data Enablement, Clinical Data Solutions - Leading Pharmaceutical Company

"Excellent knowledge by the staff, willingness to understand therapeutic details, phenomenal technology."

Associate Director, Clinical Data Science - Top 10 Pharmaceutical Company

“Risk Based Quality Management is no more an option but a standard to operate your clinical trials: CluePoints contributed to build this new landscape and now CluePoints pioneer next step to drive your monitoring activities”

RBQM Leader - Top 10 Pharmaceutical Company

"CluePoints is an industry leading RBQM platform. I would have no reservations about recommending."

RBQM Leader - Global Pharmaceutical Company

Ready to See It at Scale

Our team is ready to walk you through a personalized platform demonstration.

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