Real-World Evidence & Observational Studies
Generating robust real-world evidence from patient registries, electronic health records, claims databases, and pragmatic trials to support regulatory decision-making, health technology assessments, and lifecycle management. MTK combines epidemiological rigour with advanced analytics to transform routine clinical data into actionable evidence that strengthens your product's value proposition.
Turning Real-World Data into Regulatory-Grade Evidence
Regulatory agencies, HTA bodies, and payers increasingly require evidence that extends beyond the controlled environment of randomised clinical trials. MTK's real-world evidence practice bridges this gap by designing and executing observational studies, registry programmes, and pragmatic trials that meet the methodological and quality standards demanded by decision-makers.
Our multidisciplinary team — epidemiologists, biostatisticians, data scientists, and clinical operations specialists — collaborates with sponsors to define the right research questions, identify optimal data sources, and apply validated analytical methods that produce credible, reproducible results. From protocol development through final study report, every deliverable is built to withstand regulatory and scientific scrutiny.
Comprehensive RWE Services
Six interconnected service areas covering the full spectrum of real-world evidence generation — from study design and data sourcing through advanced analytics and health economics modelling.
Observational Study Design
Methodologically sound study designs for prospective and retrospective observational research, including cohort, case-control, and cross-sectional architectures tailored to your evidence needs.
- Protocol & SAP development
- Cohort & case-control designs
- Propensity score matching
- Bias mitigation strategies
Patient Registries
End-to-end registry design, build, and management for disease-based, product-specific, and post-authorisation registries that generate longitudinal safety and effectiveness data.
- Registry protocol development
- EDC-based registry platforms
- Long-term patient follow-up
- Annual registry reports
EHR / EMR Data Integration
Extraction, curation, and analysis of electronic health record data using validated algorithms, natural language processing, and structured phenotyping to build research-ready datasets.
- EHR data extraction & curation
- Clinical phenotyping algorithms
- NLP for unstructured data
- Data quality assessment
Pragmatic Clinical Trials
Hybrid trial designs that embed randomisation within routine clinical practice, generating effectiveness evidence that reflects real-world treatment conditions and patient populations.
- Pragmatic design frameworks
- Cluster randomisation strategies
- EHR-integrated endpoints
- Minimal disruption protocols
Post-Marketing Surveillance
Systematic monitoring of product safety and effectiveness after regulatory approval, fulfilling post-authorisation study commitments and supporting ongoing benefit–risk evaluation.
- PASS & PAES study design
- Signal detection analytics
- Risk management plan support
- Regulatory report generation
Health Economics & Outcomes Research
Economic evaluations, burden-of-illness studies, and patient-reported outcome analyses that demonstrate the value of your product to HTA bodies, payers, and healthcare systems.
- Cost-effectiveness modelling
- Budget impact analysis
- Quality-of-life assessments
- HTA dossier preparation
Harnessing Diverse Real-World Data
The strength of real-world evidence lies in the breadth and quality of its underlying data. MTK works across multiple data source types, applying rigorous curation and validation processes to ensure every dataset meets the fitness-for-purpose criteria required for regulatory and scientific use.
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Electronic Health Records
Structured and unstructured clinical data from hospital and primary care EHR systems, processed through validated phenotyping algorithms to identify patient cohorts and extract clinical outcomes.
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Claims & Administrative Data
Insurance claims, hospital discharge records, and administrative databases that provide large-scale population-level insights into treatment patterns, resource utilisation, and healthcare costs.
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Patient Registries
Disease-based and product-specific registries capturing longitudinal clinical data, treatment outcomes, and safety information from defined patient populations over extended follow-up periods.
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Wearables & Digital Biomarkers
Continuous physiological data from connected devices and wearable sensors, generating objective, high-frequency measurements of activity, sleep, cardiac rhythm, and other digital endpoints.
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Patient Surveys & PROs
Structured patient-reported outcome surveys, quality-of-life questionnaires, and treatment satisfaction instruments that capture the patient perspective on treatment effectiveness and tolerability.
Why Choose MTK for Real-World Evidence
Generating credible real-world evidence requires a partner who combines scientific rigour with data engineering expertise and deep regulatory understanding. Here is what makes MTK the right choice.
Data Expertise
Experienced data scientists and epidemiologists who specialise in curating, validating, and analysing real-world datasets from EHR systems, claims databases, registries, and connected devices.
Technology Platform
Purpose-built data integration and analytics infrastructure that ingests diverse data sources, applies quality controls, and delivers analysis-ready datasets through a governed, auditable pipeline.
Regulatory Alignment
RWE strategies designed to satisfy FDA, EMA, and HTA body requirements, with study protocols, analysis plans, and reports that follow ISPE, ISPOR, and STROBE best practice guidelines.
Methodological Rigour
Advanced statistical and epidemiological methods — propensity scoring, instrumental variables, target trial emulation — that minimise bias and produce evidence regulators can trust.
Explore RWE Solutions
Whether you need a post-authorisation safety study, a registry programme, or a comprehensive real-world evidence strategy to support your next HTA submission, our team is ready to help. Connect with us to discuss how MTK can generate the evidence your product and stakeholders require.