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Soft Robotic Heart Sleeve | Best Clinical Research Training Institute | Clinosol Research

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Globally, 41 million people suffer from Heart Failure. Mechanical pumps known as Ventricular Assist Devices (VADs) that pump blood from the ventricles to the aorta and heart transplant are two of the current treatment options; while VADs are improving, patients are still at high risk for blood clots and stroke (brain attack). Harvard researchers drew inspiration from the heart to build a completely new gadget that does not come into touch with blood. Soft pneumatic actuators put around the heart replicate the outer muscle layers of the human heart in the thin silicon sleeve. In a comparable motion to the beating heart, the actuators twist and compress the sleeve. Working of Robotic Heart Sleeve: This device is constructed of silicone, which contracts when exposed to air and expands when exposed to vacuum. It is made to fit over the heart like a sleeve. The device swells and shrinks both circumferentially and helically, similar to the outermost layers of the human heart, which a...
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Automation in Pharmacovigilance | Best Clinical Research Training Institute | Clinosol Research

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  Automation in Pharmacovigilance Introduction       Per WHO definition, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. It is a process of data acquisition (entry), data analysis and giving benefit risk communication. Here we will list out activities that are targets for automation in pharmacovigilance. In Data Acquisition (entry) Adverse event and serious adverse event collected and reported in safety database system. It is mostly transactional (exchange of data) In Data Analysis Internal data and external data surveillance occur by medical assessment and medical adjudication. It is mostly analytical and cognitive (intellectual) In Benefits Communication Risk mana...
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Safety Aggregate Reporting | Best Clinical Research Training Institute | Clinosol Research

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As the name suggests it is an aggregate (collection) of safety data of a particular drug, compiled and submitted periodically to the regulatory agencies to evaluate the risk- benefit balance of drug use. Compared with single case studies, aggregate reporting is stronger evidence concerning drug safety. Adverse drug reactions are one of the leading causes of morbidity and mortality worldwide. Safety aggregate reporting paves way to mitigate the risk of ADR caused by drugs, medical devices or biologicals. It focuses on encapsulating the safety data during both pre and post marketing phase. More importantly during the Post marketing phase, the incidence of time-related side effects can be keenly monitored. In early 1990s the Council for the Organization of Medical Sciences established a safety aggregate reporting techniques as follows: PSUR - Periodic Safety Update Report DSUR - Development Safety Update Report, that has been accepted and implemented widely in many countries under differ...
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