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 […]
Clinical trials are medical research conducted on humans that is planned to assess the efficiency of a drug or treatment and add to medical information. Some trials involve healthy members of the public, and others involve patients who may be offered the option of taking part in a trial during their […]
Clinical Research and Clinical Trials Management: Contract research organization, sometimes also called as Clinical research organization (CRO) is an organization that serves pharmaceutical, biotechnology, medical companies and various consumer healthcare industries in the field of clinical research. CRO provides support in new drugs and/or medical devices development that includes pre-clinical […]
Clinical trial plays a vital role in evaluating the safety and effectiveness of nutraceutical products. Nutraceuticals, the fusion of nutrition and pharmaceuticals, are gaining popularity as natural compounds that offer health benefits and disease prevention. They also provide a crucial avenue for validating these innovative therapies, exploring their potential benefits, […]
Clinical Trial in Nutraceuticals, which combine nutrition and pharmaceutical properties, have gained significant attention in promoting physical health, immunity, and longevity. A nutraceutical is any substance that is a food or part of a food that provides medical or health benefits, in addition to its basic nutritional value. These products […]
Medical Device Design and Development In the process of developing and introducing new medical devices to the market, verifying the essential design features is crucial. Design verification, which involves testing, inspection, and analysis, is a necessary step to ensure compliance with quality management standards such as ISO 13485. Additionally, validating […]
Post marketing surveillance (PMS) refers to monitoring of device/drug performance after successful completion of the clinical studies and the implementation of suitable action to improve patient safety. It is conducted after product is approved for sale by the European Union Medical Device Regulation (EUMDR) and the United States (US). It […]