Saturday, 15 September 2018

Post Graduate Diploma in Clinical Research: Enhancing Competencies

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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.

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 un
der Ministry of Health and family Welfare recently.

Sunday, 21 August 2016

clinical trial requirements in India is streamlined, CDSCO, clinical trials, India

clinical trial requirements in India is Streamlined

Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and encourage further investigator participation.
These changes are as follows:
Requirement of No Objection Certificate (NOC) from DCGI (Drug Controller General India) for addition of new Clinical Trial site or investigator
It was decided that the respective ethics committee, after due diligence, can approve proposals for addition of site(s) and investigator(s) and that a NOC from DCGI should not be necessary. However, the applicant would need to inform the DCGI regarding any addition/deletion of sites and investigators. Subsequently, if no objection was received from the DCGI, it would be considered admissible by the CDSCO.

Restriction of conducting three clinical trials per investigator
The impact on sponsors being unable to utilise sites/PIs (principal investigator) with specific patient populations (as a result of earlier restrictions) has now been addressed as a result of this circular. Prior to this no investigator could conduct more than three trials at any time. Once an ethics committee examines the risk and complexity involved in the proposed trial(s), they will then decide how many trials an investigator is permitted to undertake.
Requirement of 50 bedded site for clinical trials
Previously it was determined that no clinical trial shall be conducted at sites with less than 50 hospital beds. This position has been revised and it has now been established that an ethics committee will examine the trial requirements and decide whether the intended clinical trial site is suitable (or not), irrespective of the number of beds. Additionally, it was noted that sites will need to have appropriate emergency rescue and care services, along with all other necessary facilities required for a particular trial.
Requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs

Going forward, the applicant may submit parallel applications to the RCGM and DCGI seeking approval to conduct a clinical trial involving r-DNA derived drugs. DCGI will complete the review of the application and issue permission, only after RCGM clearance is received.
With these new requirements in place, processes such as assigning new sites/investigators to a study; facilitating the conduct of out-patient based studies at small hospitals/clinics that have larger patient pools; allowing motivated, research-focused investigators to undertake more trials at appropriate sites and, potentially reducing clinical trial approval timelines for rDNA based products, will help to streamline clinical trial set up and ongoing operations for sponsors.
Partnering with a CRO that has experienced, regulatory professionals both central and in-country can provide efficiencies when conducting trial in countries with unfamiliar or shifting regulations. George Clinical’s regulatory team possess a wealth of experience, region knowledge and contacts needed to communicate effectively with the appropriate, in-country regulatory agencies – such as DCGI and CDSCO. This allows us to anticipate and resolve any potential issues or hurdles that may arise throughout your trial. As such, we can provide the relevant advice and strategies tailored to your individual needs, based on the most current regional guidelines, as part of the global regulatory context. With these qualities, we are able to provide customizable trial excellence from trial design through all aspects of delivery.

Key Points:
  • New regulations will help streamline trial requirements for new/current clinical trials in India.
  • George Clinical’s regulatory team will analyse potential impact of any regulatory changes and provide expert advice on applicability and integration; ensuring your regulatory requirements are met.
  • Recommended that sponsors partner with experienced CROs with in-depth knowledge of India’s regulatory environment.
For more information on these circulars or the CDSCO, please visit:
For more information on ICBio Clinical Research  and our services, please,  CDSCO, clinical trials, India

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