The clinical trial process, determines whether a drug, biologic or medical device is safe and effective before approval for marketing and sale. Clinical trials require vigilant planning at every step of testing process as it is governed by regulations and guidelines to ensure safety and accuracy of biomedical data.
Recent escalation in clinical research efforts has increased the requirement for proficient clinical research workforce in industry, health care and academia. While federal organization, pharmaceutical companies, and research sites continue to put efforts to re-engineer the clinical research activity and ensuring conformity with federal regulations, seeking innovative approach to improve the breadth and competence of clinical research and maintain quality and safety standards, to bring the much desired products to market in a reasonable time frame to improve patient health. As the industry grows so does the demand for more highly skilled and developed clinical research professionals to address the increasing complexity of regulations. Continue reading
Good Clinical Practice is intended to be a global ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting bio medical and behavioral research studies involving human participants.
The history of Good Clinical Practice (GCP) statute traces back to one of the oldest lasting practices in the history of medicine: The Hippocratic Oath. As the guiding ethical code it is primarily known for its edict to do no harm to the patient. However, the complexities of contemporary medicine research necessitate a more detailed set of guidelines that address ethical and scientific responsibilities while involved in biomedical research. Continue reading
Clinical research is defined largely as everything but pure bench science, that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. The overarching goal of clinical research is to promote clinical application to have an important impact on the health of the population. Recent trends suggest a rapid momentum in the growth of the number of clinical trials and projection of the requirement of trained manpower in big numbers to carry out highly task-specific responsibilities.
Clinical research appears to be growing faster offering various lucrative career options which requires specialized clinical research education to carry out various job functions. The major purpose of clinical research education is to facilitate diverse cadre of clinical research professionals to create a worldwide association of clinical researchers to foster future alliance in clinical research. Continue reading
Anatomy is often simply defined as the science concerned with the study of the structure of biological organisms. Within all biological organisms, and indeed most mechanical devices of far less complexity than the human body, structure and function are intimately related. Thus, a more accurate definition of contemporary human anatomy would be the study of structure and its relation to function in the human body.
The study of anatomy possesses specific importance in clinical research. To understand the pathology, it is very important to understand the anatomy. If you don’t know how the body operates when everything is normal; you can’t understand why we get sick when the body doesn’t operate. So the understanding of anatomy helps us to identify certain therapies that can bring back the body to normal state from being diseased.
FDA defines clinical trials as voluntary research studies conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. The data generated is the most important and confidential to a clinical trial project as the fate of the drug, whether or not the drug will reach the pharmacy shelf, depends on it. A clinical trial is conducted in multiple centers and a large amount of data is generated which can be difficult to manage. Once the data is clean, a clinical study report should be written for submitting to regulatory authorities for product approval. Statistical Analysis Software (SAS) is a biostatistical tool used to manage and generate tables, listings and graphs for clinical study reports etc. Let’s discuss the basics of the SAS tool and its use in clinical domain. Continue reading