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Insights from the PHUSE Chennai SDE Navitas Life Sciences was proud to be part of the highly attended PHUSE India SDE in Chennai, sharing our expertise in biostatistics, data sciences, and regulatory submissions. We were recognized as a Major Contender in the Everest Group Clinical Data Management Operations PEAK Matrix® Assessment 2025, which...
The pharmaceutical industry is at a turning point in how it manages regulatory submissions. Agencies across the world, from the U.S. Food and Drug Administration (FDA) to the European Medicines Agency (EMA), are demanding structured and timely submissions. Companies that continue relying on legacy publishing systems risk operational bottlenecks, co...
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...
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...
Ready to Launch your next Registry? So are we! Clinical research organizations (CROs) play a vital role in advancing medical knowledge and improving patient care. With the growing prominence of patient registries in clinical research and real world evidence (RWE) generation, sponsors are recognizing the need for specialized expertise from a patient...
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 ...