We Embody a Legacy of Incredible Discoveries, Exploring the Boundaries of Innovation and Science
At Zenovel, we integrate our extensive expertise across a wide range of domains, from Good Clinical Practice to Regulatory Affairs, to present valuable insights and thought leadership. Each blog reflects our intense dedication to innovation, offering a forum to share our perspectives, groundbreaking ideas, and industry expertise. Through our blogs, we hope to uplift, inform, and support scientific, medical, and pharmaceutical innovation.
In India, sponsors of clinical trials have vital responsibilities for the ethical, regulatory, and operational success of sponsored clinical trials.
In our fast-paced pharmaceutical industry, organizations can no longer operate their business by not only obtaining operational excellence, but also
Clinical trials are crucial for drug development, but managing them is complex due to the vast amount of data and
In the dynamic, rapidly changing environment of the pharmaceutical industry, product quality and regulatory compliance is mandated. Computer System Validation
Pharmacokinetics (PK) is a key element of drug development, and describes how a drug interacts with the body by defining
Over the past few decades, clinical trial monitoring has significantly changed from conventional on-site visits to remote and risk-based monitoring
In India, sponsors of clinical trials have vital responsibilities for the ethical, regulatory, and operational success of sponsored clinical trials. As stated in the New Drugs and Clinical Trial Rules, 2019 – and the Good Clinical Practice (GCP) guidelines issued by the Central Drugs Standard Control Organization (CDSCO), sponsors have
In our fast-paced pharmaceutical industry, organizations can no longer operate their business by not only obtaining operational excellence, but also meeting stringent regulatory compliance. A strong Quality Management System (QMS) is critical to pharmaceutical operations and product lifecycle management to maintain product safety and efficacy, and regulatory compliance. At Zenovel,
Clinical trials are crucial for drug development, but managing them is complex due to the vast amount of data and patient safety concerns. Zenovel uses innovative approaches like Risk-Based Monitoring (RBM) to streamline processes, prioritize quality, and enhance trial efficiency. This blog explores RBM’s significance in clinical trials and how
In the dynamic, rapidly changing environment of the pharmaceutical industry, product quality and regulatory compliance is mandated. Computer System Validation (CSV) is essential to that goal, since it demonstrates that computerized systems used in manufacturing, testing or managing data are reliable and compliant. This Zenovel guide gives an overview of
Pharmacokinetics (PK) is a key element of drug development, and describes how a drug interacts with the body by defining its absorption, distribution, metabolism and excretion (ADME). Knowing about PK is essential in drug development to establish the safety and efficacy of drugs (both new and generic). It is Zenovel’s
Over the past few decades, clinical trial monitoring has significantly changed from conventional on-site visits to remote and risk-based monitoring with technology. These developments revolutionized clinical trial conduct, with enhanced efficiency, cost reduction, and increased data quality. At Zenovel, we are leading the charge in excessing these innovations to optimize
