Real World Data (RWE) involves collecting, analyzing and interpreting data from real-world healthcare settings to generate insights about the safety, effectiveness and value of medical products and interventions. These services enable stakeholders to make informed decisions about healthcare policies, clinical practices and product development strategies.
Data Collection and Aggregation: Data collection from a variety of sources, including electronic health records, claims databases, registries, and wearable devices to create comprehensive datasets for analysis collecting and aggregating life data.
Study Design and Protocol Development: Best for research objectives, regulatory requirements, and observational studies, including cohort studies, case-control studies, and pragmatic trials Designing RWE studies and protocols compatible with applications.
Data Analysis and Statistical Modeling: Analyzing real-life data, propensity score matching, multivariate regression to generate meaningful insights into healthcare outcomes and interventions and performing advanced data analysis, statistical modeling techniques such as machine learning.
Safety Surveillance and Pharmacovigilance: Detect, evaluate and manage adverse events and safety signals associated with medicinal products and interventions, supporting pharmacovigilance activities and regulatory reporting requirements Monitoring and analyzing real-life safety data for.
Efficacy and Comparative Effectiveness Research: Evaluating the real-world effectiveness and comparative effectiveness of medical products and interventions in diverse patient populations, clinical settings, and informing treatment decisions and health policies. to provide evidence that will inform.
Health Economics and Outcomes Research (HEOR): Health economics to evaluate the economic value, cost-effectiveness, and budget impact of medical products and interventions in real-world clinical practice. and conducting outcome research, supporting reimbursement decisions and market access strategies.
Regulatory Submissions and Labeling: Creating RWE to support regulatory submissions, label extensions, and post-market commitments, complementing traditional clinical trial data, and regulatory decision making provide supplementary evidence to support.
Quality Assurance and Data Governance: Ensuring the integrity, reliability and validity of real-life data, including data validation, standardization and compliance with privacy and security regulations Implementation of quality assurance processes and data governance frameworks for
Scientific Communication and Publication: To disseminate study findings through scientific publications, presentations at conferences and educational materials, to contribute to scientific knowledge and to inform healthcare stakeholders about medical products and To inform about the real-world effects of interventions.
Strategic Advisory and Advisory Services: Pharmaceutical companies, regulators, payers and healthcare providers to leverage real-life data in decision making and evidence-based practices Providing strategic advisory and advisory services to healthcare stakeholders, including:
Better understand real-world treatment outcomes and healthcare utilization patterns
Evidence-based decision-making support in health policy, clinical practice and product development
Supplementary evidence to traditional clinical trial data providing insights into long-term safety and effectiveness
Improved patient outcomes, healthcare quality, and cost-effectiveness through data-driven interventions
Improved market access, reimbursement and regulatory approval for medical products and interventions
Real-life data services offered by ALCOA provide comprehensive support and expertise to leverage real-world data for evidence generation, decision-making and innovation in healthcare. Our team of experts collaborates with stakeholders to design, conduct and analyze real-life data studies that produce actionable insights and improve patient care and healthcare delivery.
