Welcome to "Ask Your Biostatistician," a new expert led series from Navitas Life Sciences. Each edition explores foundational concepts that shape clin...
Ready to Launch your next Registry? So are we! Clinical research organizations (CROs) play a vital role in advancing medical knowledge and improving p...
Real World Evidence Market size The healthcare and pharmaceutical landscape is changing at an unprecedented pace. Traditional randomized controlled trials (RCTs), while the gold standard, are not always enough to answer today’s complex clinical questions. This is where real world evidence (RWE), generated from real world data (RWD) such as p...
If you own an API and your next milestone depends on a clean, fast review of your Drug Master File (DMF), this one’s for you. At Navitas Life Sciences, we help sponsors move from document chaos and last-minute firefighting to a predictable, tech-enabled regulatory submission engine, purpose-built for DMFs (drug master file / master drug file...
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...
Patient Centricity in Clinical Trials Patient centricity is at the crux of clinical drug trials and clinical medical trials, ensuring that every step of the process prioritizes patient needs, comfort, and engagement. In clinical research, success is no longer defined solely by data and endpoints. It is about the patients who make these trials possi...
As AI in pharmacovigilance gains momentum, organizations are recognizing not just the transformative potential of the technology, but also the complexity of managing its adoption. From signal detection pharmacovigilance to optimizing drug safety pharmacovigilance processes, AI promises accelerated efficiency and proactive benefit-risk management. Y...
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 ...