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 […]
Medical Writing – Success of Clinical and Regulatory Documents Consistency is a key to planning and is supported by well-designed templates, and style guides that are created by the medical writers to be used throughout the drug development process without dramatic revision. By using style guides for consistent medical writing, […]
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 […]
KOL Management by WorkSure: In modern competitive world, one of the key elements to success is creating strong relationship with the expertise leaders of one’s own field. Pharmaceutical and healthcare industries are no exception those have to maintain a strong relationship between elite physician, doctors, medical service suppliers, and teachers […]
Medical writing is a specialized field that requires extensive knowledge and expertise in writing for medical, pharmaceutical publications. It might target healthcare professionals, regulatory bodies, researchers, sales personnel or may be to educate patients. The work flow for medical writing may vary depending on the type and requirement of document, […]
Healthcare communications system forms an atmosphere encompassing clinicians, nurses, paramedics and patients. The ultimate goal of healthcare communication services is to achieve success in terms of patient outcome and satisfaction. It allows patients to be better educated about their own health, which could enable them to embrace proactive health and […]
Regulatory Affairs is fundamental in shepherding the groundbreaking treatments through the approval process, ensuring that they meet rigorous standards for safety and efficacy. Each year, the United States Food and Drug Administration (FDA) receives a considerable number of New Drug Applications (NDAs) and Biologic License Applications (BLAs). However, from 2011 […]
Medical writing regulatory is the development of various documents intended for submission to Health Authorities (HAs). These documents play a crucial role in conveying essential information accurately, transparently, and clearly to reviewers while adhering to relevant guidelines. Regulatory medical writers hold significant responsibility in the preparation of these documents, ensuring […]
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 […]