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.
For decades, the standard practice in clinical trial monitoring involved a uniform method characterized by 100% Source Data Verification (SDV)
In the fast-paced and highly regulated world of pharmaceuticals, ensuring product safety, efficacy, and quality is non-negotiable. Zenovel relies on
In clinical research, building an effective team is crucial for trial success and timely treatment delivery. Zenovel, a trusted provider
In the pharmaceutical and life sciences sectors, documentation control is critical for ensuring compliance, product quality, and patient safety. Adhering
India’s pharmaceutical industry is poised for significant growth, with projections estimating its market value to reach $130 billion by 2030.
Developing new medications is a complex and costly scientific process that takes 10-15 years and requires billions of dollars to
The race to deliver life-saving therapies to patients is increasingly faster and more complex. Pharmaceutical and biotech companies are faced with a dizzying list of challenges — global clinical trials, continuously changing regulations, multiple complicated therapeutic areas, and pressure to innovate. This is where Contract Research Organizations (CRO) come in:
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
