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 […]
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 […]
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 data management is a cyclic process of collecting, cleaning and managing data in accordance with the regulatory standards. The primary goal is to provide high-quality data obtained by reducing missing data and minimizing errors and gathering maximum data for further analysis. The data must be reliable, complete, updated and […]
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 […]