Monday, 25 January 2021
Saturday, 15 September 2018
Post Graduate Diploma in Clinical Research: Enhancing Competencies
The worldwide clinical research industry is extending at a fast pace and India is ready to pick up advantage from this prospering part. In Asia alone, this industry is worth in excess of a few billion dollars. In spite of the fact that there are various employment opportunities in this promising industry, there is a vast void relating to talented clinical research experts. Remembering the popularity for prepared clinical research experts particularly relating to clinical preliminaries, an extensive program as post graduate certificate in clinical research is currently being offered to render appropriate skills for effective treatment of clinical research. Prior to diving into the fluctuated parts of the course, allows first get comfortable with the area of clinical research.
The quickly extending clinical research industry has made an interest for talented clinical research experts particularly relating to clinical preliminaries. The post graduate recognition in clinical research is an exhaustive course which significantly upgrades the ranges of abilities and in addition profession open doors for yearning hopefuls in the clinical research space.
The quickly extending clinical research industry has made an interest for talented clinical research experts particularly relating to clinical preliminaries. The post graduate recognition in clinical research is an exhaustive course which significantly upgrades the ranges of abilities and in addition profession open doors for yearning hopefuls in the clinical research space.
Apple scores FDA clearance for heart rhythm-sensing Apple Watch
Apple has received clearance from the Food and Drug Administration for its latest Apple Watch, which can now conduct electrocardiograms and deliver alerts if atrial fibrillation is detected.
"This is the first ECG product offered over the counter, directly to consumers," said Apple chief operating officer Jeff Williams, announcing the Apple Watch Series 4 at an Apple event Sept. 12. "You can now take an ECG anytime, anywhere, right from your wrist."
To measure the heart's rhythms, a user presses their finger against a button on the watch. After 30 seconds, the watch delivers a heart rhythm classification, telling the user whether their rhythm is normal or atrial fibrillation. The data are stored in the Health app on the iPhone. From there, users can share the data in PDFs with their physicians.
The watch and heart rhythm alerts fall under the FDA's purview because they provide patients with ECG data.
"This is de novo clearance, which means it's the first of its kind," Williams said.
The data could ultimately be useful for Apple, said Chris Steel, global healthcare lead at PA Consulting.
"The analytics potential of a fully medical-grade ECG on every Apple watch users' wrist is significant, and would provide Apple with yet another hugely valuable data source on which to build additional services," he said.
Apple began making moves into heart rhythm detection in late 2017, when the company and Stanford Medicine launched a research study using the Apple Watch to identify irregular heart rhythms. That study relies on older models' heart-rate sensors, which send heart rhythm data to the Apple Heart Study app. If any of the data look like atrial fibrillation, the app notifies the wearer, who also gets a free consultation with a doctor via the American Well telehealth platform. Stanford is using the data collected in the study to look into using heart rate sensors and similar tools for precision health.
"This is the first ECG product offered over the counter, directly to consumers," said Apple chief operating officer Jeff Williams, announcing the Apple Watch Series 4 at an Apple event Sept. 12. "You can now take an ECG anytime, anywhere, right from your wrist."
To measure the heart's rhythms, a user presses their finger against a button on the watch. After 30 seconds, the watch delivers a heart rhythm classification, telling the user whether their rhythm is normal or atrial fibrillation. The data are stored in the Health app on the iPhone. From there, users can share the data in PDFs with their physicians.
The watch and heart rhythm alerts fall under the FDA's purview because they provide patients with ECG data.
"This is de novo clearance, which means it's the first of its kind," Williams said.
The data could ultimately be useful for Apple, said Chris Steel, global healthcare lead at PA Consulting.
"The analytics potential of a fully medical-grade ECG on every Apple watch users' wrist is significant, and would provide Apple with yet another hugely valuable data source on which to build additional services," he said.
Apple began making moves into heart rhythm detection in late 2017, when the company and Stanford Medicine launched a research study using the Apple Watch to identify irregular heart rhythms. That study relies on older models' heart-rate sensors, which send heart rhythm data to the Apple Heart Study app. If any of the data look like atrial fibrillation, the app notifies the wearer, who also gets a free consultation with a doctor via the American Well telehealth platform. Stanford is using the data collected in the study to look into using heart rate sensors and similar tools for precision health.
Monday, 27 August 2018
Saturday, 8 October 2016
Friday, 2 September 2016
The move will help in boosting clinical trials and research in India
Dr G N Singh, Drug Controller General of India (DCGI), said that the decisions were taken over two meetings held with all stakeholders recently. "The idea is to create conducive environment for the pharma sector to enter swiftly into drug discovery and research phase," he added.
"It has been decided to revise the condition that no clinical trial shall be conducted at a hospital having less than 50 beds. It has further been decided that an Ethics Committee shall examine and decide whether the clinical trial site is suitable for trial or not, irrespective of the number of beds," said Dr Singh.
In a bid to woo global researchers and improve the clinical trial landscape in the country, the Indian government has decided to relax rules and ease clinical trial procedures in India. The apex body to control clinical trials and drug quality issues, the Drug Controller General of India (DCGI), has amended some critical clauses, a move, that is expected to boost clinical trials in India.
Under the new norm, a clinical researcher will be allowed to perform as many trials as approved by the ethics committee, instead of the previous cap of three trials. Restrictions on number of minimum beds at the clinical trial site have also been removed. Earlier, the clinical trial site was mandated to have at least 50 beds.
The drug makers also need not take ‘no objection certificate' from the DCGI in case of addition or deletion of new clinical trial site or investigator. The new rules were notified by the Central Drugs Standard Control Organisation (CDSCO) of India under Ministry of Health and family Welfare recently.
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