Pharmacovigilance (PV) is defined as the science associated with monitoring and assessing the safety, efficacy and quality of drugs through pre-marketing and post-marketing surveillance. The main focus is to identify adverse effects that may arise from several pharmaceutical products. This process should be conducted throughout the entire lifecycle of the […]
Clinical Trials on Antibody–drug conjugates (ADCs) are gaining significant attention as a promising class of targeted anticancer therapies. The journey of ADCs began with Mylotarg, developed by Pfizer, which received its first regulatory approval in 2000. However, concerns related to safety led to its withdrawal a decade later. Its subsequent […]
Drug development refers to the process of bringing a new drug molecule into the market through preclinical and clinical practice. It requires substantial investments in terms of capital (∼$2.2 billion), human resources, research skills, and technological expertise. The process of drug development can be broadly classified into preclinical and clinical studies. The […]
CRF Designing : Case Report Form (CRF), as defined by the ICH Good Clinical Practice (GCP) guidelines, is a printed, optical, or electronic document used by clinical professionals to accurately capture all protocol-required data for each participant enrolled in a clinical trial. This data is later reported to the sponsor. […]
Clinical trials are structured biomedical or behavioral research studies on healthy human volunteers as well as patients, intended to answer specific questions about experimental medicine or therapeutic interventions such as new vaccines, drugs, or dietary supplements. These trials are conducted only when the appropriate information is submitted to a government […]
“Nutraceuticals,” a term coined by Dr. Stephen DeFelice in 1989, refers to nutritionally enriched foods and dietary supplements that are purified and formulated health products containing bioactive food compounds. These products support optimal health by supplementing the diet with herbs, vitamins, minerals, and amino acids. They are intended to enhance […]
Clinical research sponsors and pharmaceutical companies encounter numerous obstacles when seeking new drug approvals, often navigating complex regulations and stringent requirements. The clinical research sponsor requires a high-quality data report for getting new drug approval from Food and Drug Administration for their medical products. Clinical research data are important for […]
Medical affairs management identify and address the medical needs associated with products, therapies and disease states thereby driving improvement in patient outcomes in line with commercial objectives. Medical affairs came into existence in pharmaceutical and biotech industries to aid interactions between health care professionals, company representatives and the end-users. Medical […]
Clinical Education is crucial for healthcare professionals, nurses, pharmacists and physicians for proper maintenance, development and improvement of skills and knowledge regarding the efficiency, comfort and safety of the product. This solves half the equation when it reaches to further enhancement of the delivery of care. However, most often the […]
Clinical Data Management (CDM) team consists of specialists employed to enter, check and validate the information collected by the survey team. The primary objective is to reduce the number of errors and missing data. Hence, to execute the approach, an appropriate arrangement of the staff members with proper distribution of […]