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Be First-to-Market with Our Bioavailability & Bioequivalence (BABE) CRO Services Bioavailability (BA) and Bioequivalence (BE) studies are critical components in developing or marketing a generic drug. To secure approval from global health authorities such as the US FDA, pharmaceutical companies must conduct a bioequivalence study comparing thei...
Navitas Life Sciences’ medical information contact center (MICC) services help global clients achieve operational excellence, ensure compliance and enhance customer satisfaction while significantly reducing costs. Our proven approach recently enabled a leading global pharmaceutical company to achieve a 30% cost reduction through an integrate...
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...
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...
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...