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Real World Evidence: From Data to Decisions The pharmaceutical industry is undergoing a fundamental shift. Traditional randomized controlled trials (RCTs), while critical, often leave gaps in understanding how therapies perform in diverse, real-world settings. Real world evidence (RWE), drawn from real world data (RWD) such as electronic health rec...
What began in 2012 as a conventional regulatory services engagement between Navitas Life Sciences and a Top 5 pharmaceutical company has since evolved into a resilient, forward-thinking partnership, spanning more than a decade. This transformation reflects the power of a model that delivers scalability, flexibility, and sustained excellence in regu...
Navitas has been named a ‘Major Player’ in ‘IDC Marketscape : World Wide Life Sciences R&D Pharmacovigilance Technology Solutions & Consulting Services 2025 Vendor Assessment’ In the life sciences pharmaceutical industry, patient safety is the foundation. As new therapies are developed and launched at unprecedent...
Artificial Intelligence is changing the way we think about clinical trials. It’s not a future promise anymore. It’s here, now, and it’s making trials smarter and more efficient. As a US based CRO headquartered in Maryland, we’ve seen first-hand how AI is transforming operations for biotech and pharmaceutical companies ac...
Welcome to "Ask Your Biostatistician," a new expert led series from Navitas Life Sciences. Each edition explores foundational concepts that shape clinical research success, starting with a topic that’s often underestimated but absolutely vital: sample size calculation. Getting It Right from the Start: Strategic Sample Size Selection in Clini...
Empowering smarter decisions with RWE, decentralized trials, and AI driven insights. Life Sciences companies seeking to build or scale a registry, validate outcomes with regulatory-grade real world evidence, or operationalize real world data (RWD) in clinical trials, need a partner who understands the scientific, regulatory, and logistical demands ...
Navitas Life Sciences provides a powerful combination of expertise and experience to advance global health. Headquartered in Gaithersburg, US, we offer a wide breadth of services, from clinical trials management, clinical trial data management services, to expert regulatory services, and pharmacovigilance (PV) consultancy. With more than 35 years o...
Pharmacovigilance, Drug Safety | United States Navitas Life Sciences brings over 30 years of experience delivering high-impact pharmacovigilance consultancy services in the US, designed to address the unique challenges of drug safety and regulatory compliance. Our team of pharmacovigilance specialists in the US support clients across all phases of ...
Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide critical insights into how a drug is processed by the body (PK) and how it exerts its effects (PD). For pharmaceutical sponsors and biotech companies, especially those working in oncology, understanding and leveraging PK/PD data is crucial from early-stage trials through regulatory submi...
Genetic Insights in Parkinson’s Disease Research Parkinson’s disease (PD), a progressive neurodegenerative disorder, affects more than 10 million people worldwide. With global prevalence expected to double by 2040, the urgency for innovative Parkinson’s disease treatment solutions continues to grow. As the scientific community ...