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. Unlike data collected in controlled settings, 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 promotes equity in healthcare and 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.

 

In an era of precision medicine and value-based care, the integration of RWD into clinical research is essential for advancing patient-centered healthcare and driving innovation. Through RWE research, we can 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 public health and epidemiology professional, I have developed, implemented, and monitored global epidemiology research projects and risk management plans (RMPs) for new product development and post-marketing surveillance. I contributed to the design of epidemiology studies aimed at investigating natural history of disease, treatment patterns, potential safety signals, and post authorization safety studies. I worked with multiple data sources globally (e.g., CPRD, PharMetrics, MarketScan, MDV, JMDC, HIRA, SNDS GePaRD, disease registries). I contributed to clinical protocol design, development, and the review of statistical analysis plans (SAPs), assessment and analyses of safety signals (signal detection) in large adverse events reporting system databases.

I have conducted data landscaping and literature reviews, authored the epidemiology sections of the Periodic Safety Update Reports (PSURs) for known, and potential risks defined in RMPs; authored regulatory responses, risk management and safety reports, expert statements and health authority requests.

 

Currently, I cover a role as Scientific Data Strategist Director in a large CRO. In this role, my responsibilities broaden from pre-awarded to post awarded activities.

I plan and conduct hybrid (primary and/or secondary data collection) studies at different level of product life cycles, from early engagement (phase II/III), pre-launch (phase III), and post-marketing (phase IV) supporting feasibility, principal investigator/site selection, management, planning and issue resolution for hybrid clinical trials and observational studies with my main focus on the operations of large multi-database post authorization safety studies (PASS). Additional activities include protocol and statistical analysis plans (SAP) design, development, and review, literature reviews, data landscaping and identification of fit-for-purpose RWD sources to conduct RWE studies globally. I also manage relationships with third parties (e.g., data sources and data services providers), including the execution of master service agreements, work orders, startup agreements, and contract amendments. I help driving decision-making to strategically partner with select data and service providers and contribute to the development of integrated evidence generation plans by identifying key scientific and safety insights and emerging scientific concepts, developing novel approaches to identify, assess and gain access to RWD, and make recommendations on fit-for-purpose data.