Clarke Analytics

Clarke Analytics’ Data Literacy Assessment service helps organisations close the gap between data availability and data-driven action. Many businesses invest in advanced analytics tools and platforms, yet struggle to see returns, not due to lack of data, but due to a lack of confidence, skills, and shared understanding in how to use it effectively.

Our service evaluates the data fluency of your teams, from the C-suite to operational staff, across dimensions such as data interpretation, critical thinking, storytelling with data, and use of analytics in day-to-day decision-making.

Using our proprietary Data Literacy Development Framework, inspired by leading models like Mintzberg’s change cube and Gartner’s data literacy benchmarks, we provide:

• Baseline Capability Analysis: We assess team proficiency in reading, interpreting, and acting on data across functions.
• Role-Specific Maturity Mapping: Understanding that data needs differ by role, we tailor evaluations to finance, supply chain, operations, HR, and R&D audiences.
• Target-State Roadmap: We deliver a 12-month development plan with actionable next steps, aligned with your data strategy and analytics maturity goals​​.
• Cultural Readiness Insight: We identify enablers, champions and blockers for analytics adoption across the organisation, from mindset to metrics.

This assessment is ideal as a precursor to digital transformation, analytics training, or platform deployment initiatives. By illuminating where your teams stand and what support they need, Clarke Analytics ensures that everyone in your organisation is equipped to turn data into value, confidently and consistently.

Clarke Analytics’ Data Architecture Assessment service helps organisations evaluate and optimise the backbone of their analytics capability, how data is sourced, stored, integrated, governed, and accessed. Whether you’re transitioning to a modern data platform, integrating IT/OT data sources, or preparing for advanced analytics and AI, a robust architecture is essential.

Our assessment goes beyond technical infrastructure, it aligns data architecture with your business goals, analytics ambitions, and operational realities.

Using a structured evaluation framework, we assess your architecture across key domains:

• Current-State Mapping: We perform a detailed review of data sources, system interoperability, data lineage, and infrastructure (cloud, on-premise, or hybrid).
• Capability & Scalability Audit: We assess your architecture’s ability to support business use cases, advanced analytics, master data management, and real-time decisioning​.
• Governance & Compliance Readiness: We evaluate data quality management, security, access control, GDPR and AI ethical readiness as part of the architecture baseline​​.
• Gap & Risk Identification: From fragmentation in data flows to performance bottlenecks and manual workarounds, we highlight areas where current architecture hinders business agility.
• Future-State Blueprint: You receive a pragmatic roadmap tailored to your strategic objectives, covering tool recommendations, architectural patterns (e.g. data lakehouse, medallion architecture), integration layers, and next-step implementation options.

Delivered in collaboration with business and IT stakeholders, this service ensures your data architecture isn’t just fit for today, but future-ready to support AI, machine learning, and cross-functional analytics at scale.

Clarke Analytics’ Data & AI Maturity Assessment service provides organisations with a structured, evidence-based evaluation of where they stand in their journey towards becoming data- and AI-driven enterprises. With increasing investment in digital transformation, many organisations face uncertainty about whether their data, technology, skills, and governance frameworks are truly ready to support scalable AI and advanced analytics.

Our maturity assessments diagnose current capabilities and align them with your business priorities, providing a clear, prioritised roadmap to unlock value, manage risk, and accelerate adoption.

We evaluate maturity across six core dimensions, developed through industry best practice and field-tested engagements:

• Strategy & Leadership Alignment: Assessment of executive sponsorship, programme governance, business-analytics alignment, and use case portfolios​​.
• People, Skills & Collaboration: Evaluation of current team capabilities, organisational roles, cross-functional collaboration, and culture of data-driven decision-making​​.
• Data Architecture & Infrastructure: Review of current platforms, toolsets, data pipelines, integration maturity, and readiness for AI workloads​​.
• Data Governance & Ethics: Examination of data quality controls, lineage tracking, privacy compliance (e.g., GDPR, Article 22), AI transparency, and risk management frameworks​​.
• Analytics Methodology & Execution: Review of analytics workflows from descriptive through to cognitive analytics, including CRISP-DM adherence and model deployment discipline​​.
• Evaluation, Monitoring & ROI: Insights into model effectiveness, business process integration, benefit realisation, and continuous improvement mechanisms.

The deliverable is a comprehensive roadmap with actionable next steps, identifying quick wins, longer-term strategic investments, and role-based development needs. Maturity levels are benchmarked across a five-stage model (from Ad Hoc to Optimised) for both data capability and AI readiness, enabling a clear progression path​.

This service is ideal for organisations preparing to scale analytics efforts, evaluate technology investments, or embed AI responsibly across their operations. With Clarke Analytics, you gain a trusted partner to move from ambition to execution, grounded in data, guided by strategy.

Clarke Analytics’ Master Data Management (MDM) Strategy Development service empowers organisations to gain control over their most critical data assets, product, process, equipment, people, finance, and more, by aligning governance, technology, and organisational roles under a unified data strategy.

MDM is foundational to digital transformation. Without high-quality, well-managed master data, initiatives in automation, analytics, and regulatory compliance are undermined. Our approach delivers both strategic direction and operational detail, built on a rigorous review of the current state and a clear roadmap to best-practice execution.

Over the course of a structured engagement, Clarke Analytics delivers:

• People: Definition of master data roles and responsibilities, including governance councils, business data owners, stewards, and technical specialists. We also propose organisational models to support domain-level and enterprise-wide coordination.
• Process: Establishment of a practical Data Governance Framework, supported by SOPs for lifecycle management, change control, and domain-specific data workflows across ERP, MES, LIMS, PLM, and other platforms.
• Technology: Evaluation of MDM platform options based on Gartner-aligned criteria (fit-for-purpose, scalability, connectivity, compliance, cost). We guide vendor selection and advise on design patterns (e.g. registry, consolidation, coexistence).
• Data: Comprehensive assessment of existing data quality, lineage, integration gaps, and risk areas. We develop data quality management plans and identify critical dependencies and mappings between systems and domains.

The output is a board-level strategy and execution roadmap, tailored to your industry and digital maturity stage. It supports measurable gains in data trust, regulatory readiness, operational efficiency, and enterprise-wide analytics enablement.

With Clarke Analytics, your master data becomes a business asset-governed, unified, and built to scale.

Master Data Management Execution – Accelerating Data Quality, Integration and Operational Control

Under Clarke Analytics’ AI & Data Enablement & Acceleration services, our Master Data Management (MDM) delivery capabilities provide organisations with the practical expertise and tools to rapidly establish, refine, and operationalise enterprise-grade MDM practices.

Moving beyond strategy, our team works alongside your business and IT stakeholders to stand up and embed core MDM components, ensuring timely, accurate, and consistent master data across systems and functions. Whether your focus is on manufacturing, supply chain, finance, or R&D, our delivery is tailored to the complexity and regulatory needs of your domain.

Our hands-on services include:

• Data Domain Enablement: We define and implement MDM practices across key domains, products, materials, suppliers, assets, quality events, and employees, working directly with business users and system owners to capture real-world flows and hierarchies.
• Platform Implementation Support: We assist in MDM tool selection, configuration, and integration, working with technologies such as SAP MDG, Informatica, TIBCO EBX, and others. Our support includes mock-up design, sprint-based delivery, data model configuration, and real-time integration to source systems (ERP, MES, LIMS, PLM).
• Data Quality Management: We operationalise quality rules, cleansing workflows, and validation protocols aligned to regulatory standards (e.g., ALCOA+, 21 CFR Part 11). Dashboards and KPIs are developed for ongoing monitoring.
• Process Automation & Workflow Deployment: We configure role-based workflows for data creation, approval, and change management, enabling traceability, audit readiness, and reduced manual overhead.
• Migration & Cleansing Execution: Using our accelerator templates and agile sprint models, we support the preparation, cleansing, and migration of existing data to centralised master repositories, ensuring business continuity and governance.

This delivery-oriented service accelerates the transition from fragmented, manual data practices to scalable, governed MDM environments, empowering downstream AI, analytics, and automation initiatives with trusted, high-quality data.

Data Analytics Team Formation & Augmentation – Embedding Capability, Accelerating Impact

Clarke Analytics offers Data Analytics Team Formation & Augmentation services to help organisations rapidly build and scale internal analytics capacity while delivering real business value from day one. Whether you’re launching your first data initiatives or expanding existing capabilities, we bring the right blend of expertise, structure, and enablement to accelerate progress.

Our approach is grounded in practical delivery and skills transfer, ensuring that your teams are empowered.

What we deliver:

• Team Formation & Skills Mapping: We help clients define the right roles across data science, engineering, architecture, and governance based on business priorities and technical maturity. We guide capability structuring and help establish Centres of Excellence (CoEs) or federated models as needed.
• Interim Expertise & Specialist Resourcing: We embed experienced Clarke Analytics consultants to fill capability gaps in roles such as data architects, data engineers, visualisation specialists, and domain-specific analysts. Our staff can lead strategic projects while mentoring your internal teams.
• Architecture & Platform Setup: For organisations starting from a low analytics baseline, we design and implement modern, scalable analytics environments, including cloud-based data pipelines, data lakes, and reporting platforms using Microsoft Azure, Power BI, and related technologies​.
• Embedded Delivery Pods: In partnership with clients, we deploy agile analytics pods focused on specific business functions (e.g. energy usage analysis, supply chain visibility, manufacturing quality). These pods deliver production-ready dashboards and models while building internal skill and process maturity.
• Training, Onboarding & Handover: We ensure sustainable capability through role-based training, playbooks, and mentorship, enabling your team to confidently manage and evolve the analytics environment post-engagement.

With Clarke Analytics, you gain immediate access to high-impact analytics talent and delivery structure, without long ramp-up periods or reliance on generic contractors. We build with you, not just for you, creating lasting capability and real-world outcomes.

Data Analytics Proof of Value – Navigating Uncertainty, Demonstrating What’s Possible

Clarke Analytics’ Data Analytics Proof of Value (PoV) service helps organisations move from conceptual curiosity to credible, evidence-based insight, bridging the critical gap between business ambition and data-driven reality. These early-stage explorations are often the most challenging: there is rarely a predefined solution, the data landscape is uncertain, and success hinges on informed experimentation and iteration.

We specialise in bringing structure, rigour, and cross-functional alignment to these ambiguous analytics initiatives, ensuring that your first steps lead to meaningful business outcomes.

Our approach includes:

• Business-Driven Scoping: We work closely with your leadership and subject matter experts to frame key questions, success criteria, and potential use case hypotheses. We focus on the right problems, those with measurable impact and alignment to your strategic goals.
• Data Feasibility Analysis: We assess whether the available data is fit for purpose, conducting exploratory data profiling, quality checks, and early transformation pipelines using tools such as Power BI, Spotfire, Python, and R​.
• Iterative Modelling & Insight Generation: With no off-the-shelf roadmap, our senior data scientists and business consultants iteratively test hypotheses, develop visual narratives, and apply appropriate analytics methods, from descriptive dashboards to predictive models.
• Stakeholder Engagement & Education: PoV work is as much about organisational learning as technical delivery. We help clients build confidence in the analytics process, demonstrating what’s possible while managing expectations and clarifying next steps.
• Outcome-Ready Reporting: The engagement concludes with a concise, business-facing results pack detailing findings, insight prototypes, data constraints, and a go-forward roadmap for scaling, refining, or re-scoping the initiative.

At Clarke Analytics, we recognise that the hardest part of an analytics journey is often the beginning. That’s why our PoV engagements are led by senior practitioners who blend statistical fluency with commercial acumen, ensuring your early analytics investments are grounded, credible, and direction-setting.

FDA 510(k) Statistical Analysis & Submission Support – De-Risking Regulatory Entry with Proven Analytics Rigor

Clarke Analytics’ FDA 510(k) Service supports medical device manufacturers preparing U.S. FDA or EMA submissions by providing expert statistical analysis, design validation, and independent third-party verification. We help clients meet the high bar for regulatory scrutiny with defensible, well-documented, and audit-ready evidence-grounded in statistical integrity and regulatory expectation.

Our team combines deep domain knowledge in regulated life sciences with advanced statistical and data science capability, ensuring that every aspect of your pre-market submission is quantitatively robust and regulator-ready.

What we provide:

• Pre-Submission Design Review: Evaluation of test protocols, sample sizes, and statistical methodologies in alignment with FDA and EMA expectations, including confidence interval strategies and control group justification​.
• Study Design & Protocol Optimisation: We work with client teams to ensure study designs are statistically sound, efficient, and sufficiently powered to demonstrate substantial equivalence or clinical performance.
• Statistical Analysis Execution: We conduct primary and interim analyses using a wide range of advanced techniques including ANOVA, Kruskal-Wallis, Wilks’ Lambda, Bland-Altman plots, Deming regression, and bootstrap simulation​​.
• Regulatory Submission Documentation: We deliver clearly written, regulator-facing statistical reports suitable for direct inclusion in your 510(k), CE Mark, or MDR submission packages, structured to separate independent analysis from sponsor influence.
• Change Control & Lifecycle Support: Beyond initial submission, we support clients with ongoing change control strategy, impact assessment of updates to testing protocols, and long-term monitoring analytics frameworks.

This service is especially valuable for clients seeking independent, third-party statistical validation, ensuring objectivity, enhancing submission credibility, and reducing the risk of regulator challenge or delay.

At Clarke Analytics, we don’t just crunch the numbers. We help you defend them with confidence, bringing statistical clarity and regulatory assurance to your product’s market entry journey.

End-to-End Analytics Solution Design & Implementation – Transforming Manufacturing Performance Through Data-Driven Execution

Clarke Analytics delivers end-to-end analytics solutions that enable manufacturers across diverse sectors, including pharmaceuticals, MedTech, electronics, FMCG, and industrials, to unlock operational excellence, strengthen quality control, and ensure regulatory or compliance alignment through trusted, scalable, and insight-driven systems.

From initial scoping to deployment, our solutions are engineered to align precisely with business-critical outcomes. We integrate modern technology platforms, unify data across heterogeneous sources, and deploy advanced analytics models to solve high-value challenges in throughput, waste, downtime, yield, and product quality.

Our offering includes:

• Business-First Solution Design: We work with leadership and domain SMEs to define operational goals, compliance constraints (e.g., FDA 21 CFR Part 11, ISO, GAMP 5, or corporate QMS), and high-priority use cases. These guide all aspects of analytics development, from tooling to data flows to model selection.
• Technology Platform Selection & Architecture: Using a vendor-agnostic assessment framework, we help clients select and configure the right combination of data platforms and analytics tools (e.g., Power BI, TIBCO Spotfire, SIMCA, Azure Synapse, Databricks, SAP BW/4HANA) to suit on-premise, hybrid, or cloud-first strategies​.
• Data Integration & Engineering: We design and implement data pipelines that integrate IT, OT, IoT, and lab systems, including MES, SCADA, ERP, LIMS, PLM, historians, and shopfloor sensors, creating a consistent, governed, and analysis-ready data layer for diagnostics, forecasting, and optimisation​​.
• Advanced Analytics & Modelling: We develop use-case-specific models for predictive maintenance, golden batch detection, yield forecasting, energy optimisation, anomaly detection, and demand-supply balancing—using statistical, ML, and time-series approaches under CRISP-DM and DMAIC best practices.
• Deployment, Monitoring & Value Realisation: We support validated model deployment, data lineage tracking, automated insights delivery (e.g., dashboards, alerts), and lifecycle governance. Post-deployment, we remain engaged to ensure adoption, continuous improvement, and ROI tracking.

This service empowers manufacturers to shift from reactive operations to proactive, insight-driven decision-making, improving quality, reducing downtime, increasing compliance assurance, and enabling strategic agility.

With Clarke Analytics, you get more than analytics, you get a partner in precision manufacturing transformation, bridging operational expertise with modern data science to deliver lasting impact.

Customised Training Programmes

Developed in collaboration with the Irish Centre for Business Excellence (ICBE) Business Excellence and Advanced Productivity Skillnet Programmes, the Clarke Analytics’ structured training programmes (Levels 0.5, 1, 2, and 3) progressively build attendees’ data literacy, analytics proficiency, and critical thinking skills. Starting with foundational data concepts and generative AI-driven analytical thinking, learners advance through practical exercises, collaborative teamwork, and applied analytics projects using real-world datasets, culminating in mastery-level, deep-dive mentoring across complex analytics use cases and data governance strategies. There is more detail on the course level 1 under the Our Courses section.

In-person / Online Blended Learning Options

Our flexible training approach combines interactive in-person workshops with convenient online learning sessions. This blended methodology enhances data literacy through theoretical instruction and hands-on practice, facilitated by group-based exercises and project collaboration, ensuring practical application of skills and fostering effective cross-functional teamwork. There is more detail on the course under the Our Courses section.

The Generative AI course offered by Clarke Analytics provides attendees with foundational knowledge and practical skills in leveraging generative AI tools. Participants learn effective prompting techniques, understand the opportunities and risks of AI, and practice critical thinking through real-life scenarios and interactive team-based exercises, empowering them to confidently integrate AI-driven insights into their decision-making processes. There is more details on the course under the Our Courses section.