Real-World Evidence
Transforming Data into Actionable Insights
Real-world evidence (RWE) goes beyond the confines of clinical trials to uncover how treatments, interventions, and health services truly perform in everyday practice. At Kernel, our RWE approach harnesses multiple, complementary, real-world data sources ranging from electronic health records (EHRs) and patient registries to insurance claims databases and observational studies, offering deep, context-specific insights that can refine clinical care, inform policy, and spotlight new research opportunities. By focusing on findings derived from everyday patient experiences and outcomes, we help you capture nuances that strictly controlled settings may miss, ensuring your results are both scientifically rigorous and applicable in real-world needs.
Informing Policy, Improving Care
By combining a deep understanding of real-world data methodologies, observational research tools, and post-approval safety monitoring, we transform everyday healthcare encounters into robust, evidence-based narratives. These insights can guide clinical initiatives, refine healthcare delivery strategies, and ensure post-marketing vigilance, helping regulators, sponsors, and clinicians make more informed decisions. In an era where healthcare ecosystems are increasingly data-driven, real-world evidence has evolved into a powerful instrument for quality improvement and accountable care.
Contact UsObservational Studies
Unlocking Real-World Insights
At Kernel CRO, we transform real-world data into actionable insights. Our observational studies provide the evidence you need to understand the safety, effectiveness, and long-term impact of your products in diverse patient populations. Our approach is rooted in scientific rigor, regulatory compliance, and a commitment to delivering insights that drive informed decision-making. Whether you’re looking to evaluate the long-term safety of a marketed product, understand its effectiveness in real-world settings, or address specific research questions, Kernel is your trusted partner.
Observational studies bridge the gap between clinical trials and real-world practice
They help you:
Our Comprehensive Observational Study Services
We offer end-to-end support for observational research, tailored to your unique needs.
- Design robust studies: prospective, retrospective, and cross-sectional.
- Develop protocols aligned with regulatory standards and research objectives.
- Access diverse patient populations through our global network.
- Utilize advanced tools like electronic health records (EHRs), registries, and patient-reported outcomes (PROs).
- Analyze real-world data to uncover safety and effectiveness trends.
- Identify insights that clinical trials may miss.
- Ensure adherence to EMA, FDA, and ICH guidelines.
- Prepare and submit study reports for regulatory approval.
- Apply advanced statistical methods for accurate analysis.
- Deliver clear, actionable insights through comprehensive reports
Pharmacovigilance
Ensuring Safety at Every Stage
At Kernel CRO, Pharmacovigilance (PV) is more than a regulatory obligation, it’s a multidisciplinary commitment to safeguarding patient well-being across the product lifecycle. Our safety scientists, medical doctors, data analysts, and regulatory experts unite their diverse expertise to detect potential signals early, mitigate risks, and maintain strict global compliance.
Core Pharmacovigilance Guidelines & Frameworks
ICH E2B Compliance
We follow ICH E2B guidelines for the electronic transfer and management of Individual Case Safety Reports (ICSRs), ensuring standardized data formats and seamless global submissions.
ICH E2B Compliance
We follow ICH E2B guidelines for the electronic transfer and management of Individual Case Safety Reports (ICSRs), ensuring standardized data formats and seamless global submissions.
EU-GVP & Regional Regulations
Our team stays current with evolving guidelines, such as Good Pharmacovigilance Practices (GVP) in the EU and local requirements in the MENA region, ensuring continuous alignment with best practices.
EU-GVP & Regional Regulations
Our team stays current with evolving guidelines, such as Good Pharmacovigilance Practices (GVP) in the EU and local requirements in the MENA region, ensuring continuous alignment with best practices.
Risk Management & Periodic Reporting
We develop Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other documentation per ICH guidance to maintain transparency with health authorities and stakeholders.
Risk Management & Periodic Reporting
We develop Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other documentation per ICH guidance to maintain transparency with health authorities and stakeholders.
Multidisciplinary Team Approach
Safety Scientists & Medical Doctors
Identify, analyze, and interpret adverse events to evaluate causal relationships and clinical significance.
Data Analysts & Epidemiologists
Harness advanced analytics, detect safety signals, and conduct pharmacoepidemiologic studies to validate findings in large datasets.
Regulatory Affairs Specialists
Navigate regional and international regulations (ICH, EU, local laws), ensuring prompt, accurate safety reporting and clear communication with health authorities.
Medical Writers & Project Managers
Compile precise, compliant documentation including ICSRs, PSURs, and RMPs and coordinate timelines, deliverables, and sponsor communications.
Key Pharmacovigilance Services
- Develop SOPs, training programs, and infrastructure compliant with global standards
- Coordinate with cross-functional teams to embed PV seamlessly into clinical operations
- Collect, assess, and submit AE/SAE reports in accordance with ICH E2B guidelines
- Integrate MedDRA and WHO-Drug coding for consistent event classification
- Apply advanced statistical tools to unearth emerging safety concerns early
- Propose and implement targeted interventions and RMPs to safeguard patient welfare
- Conduct in-depth assessments to validate adherence to local and international regulations
- Recommend corrective actions for continuous quality improvement
Services
Flexible Service Options to Meet Your Needs
At Kernel, we understand that every project is unique. That’s why we offer a range of service options to fit your specific requirements:
Full-Service Support
End-to-end pharmacovigilance and post-marketing surveillance for specific study or product.
Full-Service Support
End-to-end pharmacovigilance and post-marketing surveillance for specific study or product.
Standalone Services
Manage any part of your pharmacovigilance project, from signal detection to regulatory reporting.
Standalone Services
Manage any part of your pharmacovigilance project, from signal detection to regulatory reporting.
Full Outsourcing
Comprehensive management of your pharmacovigilance function across multiple studies or products.
Full Outsourcing
Comprehensive management of your pharmacovigilance function across multiple studies or products.
Public Health
Transforming Communities Through Research and Innovation
At Kernel, we are deeply dedicated to advancing public health by conducting rigorous research, innovative data analytics, and outcome-focused solutions. Our mission is to prevent disease, promote wellness, and strengthen health systems across Jordan and the Eastern Mediterranean region.
Why Public Health Matters
Public health is the cornerstone of thriving communities. It focuses on:
Our Public Health Expertise
We specialize in addressing critical public health challenges across diverse therapeutic areas and fields.
Disease Surveillance & Outbreak Response
- Implementing and refining surveillance systems.
- Advanced epidemiological methods and digital tools for rapid outbreak detection and control.
- Providing timely data to inform targeted public health interventions.
Community Health & Behavioral Research
- Investigate social determinants of health through assessments and surveys design
- Designing culturally tailored health promotion and disease prevention programs.
Environmental Health & Epidemiology
- Evaluating the impact of environmental factors on public health.
- Conducting robust epidemiological studies to inform policies and mitigate environmental risks.
Maternal & Child Health Research
- Focusing on prenatal care, maternal mortality, child nutrition, and developmental outcomes.
- Supporting policies and programs that expand access to quality healthcare for mothers and children.
Health Equity & Access Research
- Identifying disparities in health access and outcomes.
- Designing research-based strategies to promote equitable healthcare systems for all populations.
Mental Health Research
- Studying mental health prevalence, treatment effectiveness, and the impact of social factors.
- Informing policies and programs that strengthen mental well-being.
Pharmacoeconomics
(Health Economic Evaluation) for Real-World Evidence
Definition and purpose. Pharmacoeconomics evaluates the value of medicines and health technologies by comparing costs and health outcomes to inform coverage, pricing, and utilization decisions. Integrated with Real-World Evidence (RWE) from routine care, pharmacoeconomic evaluations support Health Technology Assessment (HTA) by quantifying clinical benefit, patient impact, and budget implications under real practice conditions. Our work aligns with international methods and reporting guidance, including the Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) and NICE’s Health Technology Evaluations manual (2022).
Methods we use. Depending on your decision context, we apply Cost-Effectiveness Analysis (CEA) and Cost-Utility Analysis (CUA)—typically reporting Incremental Cost-Effectiveness Ratios (ICERs) per Quality-Adjusted Life Year (QALY) gained—alongside Cost-Benefit Analysis (CBA) or Cost-Minimization Analysis (CMA) where appropriate. For extrapolation beyond observed data and to represent patient pathways, we build decision-analytic models (e.g., state-transition/Markov, discrete-event, dynamic transmission), implement deterministic and probabilistic sensitivity analyses, and follow established model validation practices.
What we deliver
Decision models
(Markov, discrete-event) with transparent structure, parameter sources, and face-validation with clinical experts.
Cost-effectiveness results
ICERs, cost-effectiveness planes, cost-effectiveness acceptability curves, scenario & threshold analyses.
Budget Impact Analysis
with base-case and scenario runs (uptake, price, mix), and payer-specific tabulations.
Evidence synthesis
targeted literature reviews, meta-analytic inputs, mapping of clinical endpoints to utilities and costs.
Submission-ready packages
CHEERS-compliant report, technical appendix, interactive dashboards, and HTA-aligned summary for decision makers.
Country adaptation
perspective, time horizon, discounting, and unit costs localized to payer requirements; transferability analysis for multi-country use.