Consulting & Services

Solutions / CONSULTING & SERVICES

Expert Guidance from Implementation to Ongoing Strategy

Technology enables better clinical trial oversight. Expert guidance sustains it. CluePoints' clinical specialists bring decades of hands-on industry experience to every engagement, from Risk-Based Quality Management (RBQM) framework design and platform implementation to medical and safety review workflow design, medical coding governance, and inspection readiness preparation. We work alongside your team across every product in the CluePoints platform, building internal capability to ensure the investment delivers results.

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Support Across the Full CluePoints Platform

Every CluePoints consulting engagement is scoped around defined outcomes. Our specialists cover the full clinical data oversight lifecycle, across RBQM, Medical & Safety Review (MSR), Intelligent Medical Coding (IMC), Intelligent Query Detection (IQD), and the Site Profile & Oversight Tool (SPOT).

RBQM Framework Design and CtQ Mapping

Build a documented, ICH E6(R3)-aligned RBQM framework from the ground up: Critical-to-Quality (CtQ) factor identification, risk control mapping, Key Risk Indicator (KRI) libraries, Quality Tolerance Limit (QTL) configurations, and monitoring strategy design, tailored to your therapeutic areas, study designs, and operating model.

RBM/RBx Implementation

CluePoints is the leading authority in risk-based execution (RBx). Our dedicated professional services team guides your RBQM technology implementation every step of the way: shaping your RBx strategy, aligning to FDA and ICH guidelines, configuring the platform, and building the tactical monitoring practices and KRI frameworks your teams need to execute with confidence.

Platform Configuration and Deployment

Configure the full CluePoints platform across CMP, SPOT, MSR, IQD, and IMC to match your study designs, EDC environments, data standards, and internal workflows, reducing time to first compliant deployment and ensuring the platform works the way your teams work.

Training and Change Management

Equip clinical operations, Data Management (DM), safety, medical coding, and quality assurance teams with the skills and process knowledge to execute independently across every CluePoints product. We design and deliver training that builds genuine capability, not just platform familiarity, so investment delivers results long after go-live.

Site Inspection Readiness

Our RBQM experts analyze all clinical and operational data to identify sites at risk of inspection, empowering you to prepare for and mitigate potential issues before regulators arrive. We review RBQM and clinical data oversight documentation, audit trail readiness, and oversight narratives to meet FDA, EMA, and MHRA expectations. Over 25% of studies fail first-cycle regulatory reviews due to data quality issues. CluePoints helps ensure yours are not among them.

Mergers and Acquisitions

Are there hidden data quality issues in clinical trial assets backing a proposed acquisition? CluePoints applies rigorous statistical testing to clinical trial data to identify irregular patterns, data integrity gaps, and oversight deficiencies that could become regulatory liabilities after a deal closes. Our experts validate data integrity and the efficacy of associated processes, providing a solid foundation for regulatory assessment.

Structured Engagement. Measurable Outcomes.

Every CluePoints consulting engagement follows a structured model focused on defined outcomes, not on open-ended time-and-materials.

Step 1

Assess

We begin with a structured assessment of your current clinical data oversight capability, identifying gaps, mapping existing workflows, and establishing a baseline against which improvement can be measured.

Step 2

Design & Implement

Our clinical specialists design and implement frameworks, configurations, and workflows tailored to your operating model, with hands-on support through platform deployment, team onboarding, and first study execution.

Step 3

Sustain & Optimize

We stay engaged beyond go-live, providing training refreshers, inspection-readiness support, portfolio expansion guidance, and maturity benchmarking to ensure capabilities grow as your study program evolves.