Electronic Records Analyses Services

Unlocking Data-Driven Insights from Electronic Health Records (EHRs) and Real-World Data (RWD)

In the era of digital healthcare, Electronic Records Analyses (ERA) play a pivotal role in clinical research, regulatory decision-making, and real-world evidence generation. At Clievi, we specialize in advanced analytics of Electronic Health Records (EHRs), Electronic Medical Records (EMRs), claims databases, and registry data, transforming raw patient information into actionable insights for clinical trials, health outcomes research, and regulatory compliance.

Our Electronic Records Analyses Solutions

1. Data Acquisition, Integration, and Standardization

EHR and Claims Data Extraction: Secure collection of structured and unstructured data from hospital systems, insurance databases, clinical registries, and wearable devices.
Data Standardization: Mapping patient records to global standards such as OMOP Common Data Model (CDM), FHIR (Fast Healthcare Interoperability Resources), and ICD-10/LOINC/SNOMED-CT coding systems.
Data De-Identification and Privacy Compliance: Ensuring HIPAA, GDPR, and 21 CFR Part 11 compliance through robust data anonymization techniques.
Interoperability Solutions: Integration across multiple platforms to facilitate harmonized multi-center research and longitudinal patient data tracking.

2. Real-World Evidence (RWE) and Outcomes Research

Comparative Effectiveness Research (CER): Evaluating treatment efficacy using propensity score matching (PSM), inverse probability weighting (IPW), and instrumental variable analysis (IVA).
Health Economics and Outcomes Research (HEOR): Analyzing healthcare utilization, cost-effectiveness, and reimbursement models based on real-world patient records.
Patient-Reported Outcomes (PROs): Merging clinical data with QoL (Quality of Life) assessments, symptom tracking, and patient satisfaction metrics.

3. AI-Driven Predictive Analytics and Risk Modeling

Machine Learning-Based Pattern Recognition: Identifying hidden trends in diagnosis, disease progression, and treatment adherence through natural language processing (NLP) and deep learning algorithms.
Risk Stratification Models: Predicting patient risk for hospital readmission, disease complications, and treatment failure using advanced Cox proportional hazards models and neural networks.
Survival Analysis: Conducting Kaplan-Meier survival curves and parametric survival models for disease prognosis and patient outcome predictions.

4. Drug Safety and Pharmacovigilance Analytics

Adverse Event Detection: Mining EHR and spontaneous reporting system (SRS) databases to detect early safety signals and post-marketing adverse drug reactions (ADR).
Causal Inference in Drug Safety: Applying Bayesian hierarchical models and disproportionality analysis (PRR, ROR) to assess drug-event associations.
Regulatory Compliance for Drug Monitoring: Aligning post-marketing surveillance (PMS) studies with FDA Sentinel Initiative and EMA EudraVigilance protocols.

5. Clinical Trial Feasibility and Patient Recruitment Optimization

Site Selection and Patient Identification: Using AI-driven cohort discovery tools to match trial inclusion criteria with real-world patient populations.
Longitudinal Patient Tracking: Monitoring disease progression, medication adherence, and treatment response through retrospective and prospective EHR analyses.
Decentralized Clinical Trial (DCT) Integration: Leveraging remote monitoring data and real-time EHR linkage to support virtual and hybrid trial models.

6. Regulatory-Grade Electronic Records Analyses for Compliance and Submission

Regulatory-Ready RWE Submissions: Supporting FDA, EMA, MHRA, and PMDA submissions with validated EHR-derived evidence.
Health Technology Assessment (HTA) Support: Developing evidence dossiers for NICE, CADTH, ICER, and other HTA bodies.
21 CFR Part 11-Compliant Electronic Recordkeeping: Ensuring audit-ready documentation for clinical trials, real-world studies, and observational research.

Why Choose Clievi for Electronic Records Analyses?

Regulatory and Data Security Compliance: Expertise in HIPAA, GDPR, 21 CFR Part 11, and HITRUST-certified data handling.
Cutting-Edge Analytical Frameworks: Leveraging AI, deep learning, and Bayesian modeling for real-world evidence generation.
Industry-Specific Expertise: Supporting pharmaceutical companies, CROs, regulatory agencies, and health insurers with high-quality data analytics.
Customizable and Scalable Solutions: Tailored analytics for diverse applications, from clinical trial design to post-market surveillance.

Get Started with Clievi’s Electronic Records Analyses Services

Harness the power of electronic health records and real-world patient data to drive evidence-based decision-making. Contact Clievi today to explore our Electronic Records Analyses Solutions for clinical, regulatory, and market access needs.