Welcome to my Real World Evidence Pharma Insights Hub, a portal with the trends and developments of Real World Data Use and Drug Safety in the pharmaceutical industry.
Real-world data (RWD) plays a pivotal role in modern clinical research, offering a rich and diverse source of information that complements traditional clinical trial data. RWD provides insights into how treatments perform in everyday clinical practice, reflecting the complexities of patient populations, treatment patterns, and healthcare delivery systems. This wealth of real-world evidence (RWE) not only enhances our understanding of a treatment's effectiveness and safety but also informs clinical decision-making, healthcare policy, and regulatory decision-making.
By leveraging data from electronic health records (EHR), claims databases, patient registries, wearable devices, and other sources, researchers can generate insights that are more representative of real-world patient experiences. This enables us to identify patterns, trends, and outcomes that may not be captured in traditional clinical trials, such as long-term safety outcomes, treatment effectiveness in diverse patient populations, and treatment adherence.
Furthermore, RWD allows for the evaluation of treatments in broader patient populations, including underrepresented demographics, and varying socioeconomic backgrounds. This inclusivity ensures that treatments are evaluated in populations that more closely resemble those encountered in clinical practice.
In addition to its role in clinical research, RWD contributes to healthcare decision-making. Healthcare providers can use RWE to inform treatment decisions, tailor therapies to individual patient needs, and monitor treatment outcomes. Payers and policymakers can leverage RWE to evaluate the value and cost-effectiveness of treatments, guide reimbursement decisions, and develop evidence-based healthcare policies.
Through RWE research, we can also accelerate the development and adoption of safe, effective, and personalized therapies, ultimately improving patient outcomes and enhancing the quality of healthcare delivery worldwide.
Get to know me
My Expertise
RWE & RWD | Epidemiology | Clinical Research & Operations | Drug Safety | Nutritional Sciences
Public Health, Drug Safety & Epidemiology
Clinical Research & Operations
Sport Nutrition & Mental Training
By completing a PhD in Pharmacoepidemiology & Health Services Research, and throughout the different experiences in the pharmaceutical industry, I have developed a solid scientific background in multiple therapeutic areas and strong clinical operation experience.
As a public health and epidemiology professional, I have spearheaded the development, implementation, and monitoring of global epidemiology research projects for new product development and post-marketing surveillance. My contributions include designing epidemiology studies to investigate natural history of disease, treatment patterns, safety signals, and post-authorization safety studies (PASSs).
I have worked with diverse data sources (e.g., CPRD, PharMetrics, MarketScan, MDV, JMDC, HIRA, SNDS, GePaRD, disease registries), and contributed to clinical protocol design, development, review of statistical analysis plans (SAPs), and signal detection in large adverse event reporting system databases.
I have conducted data landscaping, literature reviews, and authored the epidemiology sections of Periodic Safety Update Reports (PSURs) for known and potential risks as defined in Risk Management Plans (RMPs). Additionally, I have authored regulatory responses, risk management and safety reports, and expert statements.
As the Scientific Data Strategist Director at a leading CRO, I oversee a broad range of activities from pre-award to post-award phases. My role involves planning and conducting hybrid studies (primary and/or secondary data collection) throughout different product life cycle stages, including early engagement (Phase II/III), pre-launch (Phase III), and post-marketing (Phase IV).
I specialize in large multi-database PASS, focusing on feasibility, data source selection and management, planning, and issue resolution for hybrid trials and observational studies. My responsibilities also include reviewing protocols and SAPs, conducting literature reviews, data landscaping, and identifying suitable RWD sources for RWE studies.
Additionally, I manage relationships with third-party data sources and service providers, overseeing master service agreements, work orders, startup agreements, and contract amendments. I drive strategic decision-making to partner with select data and service providers, contributing to integrated evidence generation plans by identifying key scientific and safety insights, developing novel approaches to access RWD, and recommending fit-for-purpose data solutions.