Clinical trialshelp test new methods or drugs or devices for diagnosis, prevention or treatment of various health conditions or diseases. Clinical trials are conducted to understand the safety and efficacy of a new drug or device that undergoes different stages of approval before it is sold in the market. The extensive research for the drug or device involves years of […]
What is the role of quality in clinical trials? Clinical trials provide information on the safety and efficacy of drugs under study. Sponsors of the clinical trial ensure that the investigators are following the compliant protocol and collecting and reporting quality data. Quality, one of the core modules of the trial, can be defined as a set of characteristics that […]
Why is monitoring required? Monitoring is mandated by the Food and Drug Administration (FDA) in order to validate the integrity of the clinical trial. In general, this process is hugely personnel-intensive and involves site visits to inspect personnel, facilities, equipment, processes and documentation. It has been estimated that one third of the budget of the trial is spent on on-site […]
The most challenging task of a clinical trial is the recruitment of potential participants. Enrolling candidates in the trial involves a lot of obstacles that include limited knowledge on trials, concerns regarding deviating from standard care protocols, uncertainties in the process and personal hurdles. Also, there could be an intense competition among the candidates to participate in the trial in […]
Training in Clinical Trial Management :- Clinical research comprises of testing and ascertaining the safety and efficacy of new unapproved health care products, including medical devices, biologics, and pharmaceuticals in human subjects. Clinical trials in human subjects are a pre-condition for marketing approvals, by local regulatory authorities such as the U.S. Food and Drug Administration (FDA).
What are the key tasks of a Clinical Research Associate in Clinical Trial experiments? CRA Training :- A CRA (Clinical Research Associate) is responsible in design, scheduling, preparation, execution and review of a clinical trial experiment to guarantee it that it sticks to regulatory and ethical guidelines. CRA’s also play a key role in data exchange with all the stake holders.