ICBio Institute of Clinical Research

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.

Apple scores FDA clearance for heart rhythm-sensing Apple Watch

By Rachel Z. Arndt  | September 12, 2018

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.

BA BE centre @ ICBio Approved by DCGI, CDSCO,

BA BE centre @ ICBio Approved by DCGI, CDSCO,

ICBioCRO ; BA BE centre Approved by DCGI, CDSCO,

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.

www.cdsco.nic.in/

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: http://www.cdsco.nic.in/forms/list.aspx?lid=1604&Id=31

For more information on ICBio Clinical Research  and our services, please visit:www.icbiocro.com,  CDSCO, clinical trials, India

or write to us on info@icbiocro.com 

we are Hiring, Interested to be part of ICBio Team

we are Hiring, Interested to be part of ICBio Teamwww.icbiocro.com

BA BE centre @ ICBio Approved by DCGI, CDSCO,

Looking for Contract Research Organisation In India, ICBio your trusted partner for Clinical Research activity,

www.icbiocro.com

Now ICBio adds BA BE facility in its operations, approved by CDSCO,

Now ICBio adds  BA BE facility in its operations, approved by CDSCO, www.icbiocro.com

ICBio CRO is one of the leading Contract Research Organization in Asia, based in Bangalore, INDIA, offering End to End Research Services / Functional Service Providers (FSP) to the Global Pharmaceuticals and Cosmetics Industries,conducting clinical trials in India and the Emerging Markets across globe.

ICBio has a well-designed, custom-built, compliant Facility to conduct various activities of Clinical Research. It is spread over a total floor area of 20,000 sq.ft, includes Clinical Units, Bio analytical Laboratory, Volunteer screening, Volunteer Information centers and external archives.

Our team leading various departments has a several years of experience in the Pharmaceutical Companies and CROs together. With the help of this expertise, we offer our services in Phase II, III Clinical trials, medical writing services and Bioavailability / Bioequivalence studies in Healthy volunteers as well as Patients.

ICBio has vast expertise in clinical trial and project management, having conducted complex clinical development programs of biologics, small molecules, and completed them within the time. We have a long track record of evaluating the safety and efficacy for a wide range of therapeutic indications, our expertise lies in diabetes and metabolic disorders with the support of its pan India network of Investigators and sites.

We are Client focused, flexible and also cost effective CRO in India, we focus on quality and add value services to our clients', we strictly adhere to timely execution of clinical projects within budget and accurate, reliable and comprehensive data by following ICH-GCP guidelines.

ICBio served a diverse customer base of more than 30 satisfied customers. We have consistently exceeded our customers' expectations in terms of quality, speed and affordability.

ICBio is an ISO 9001: 2008 certified company and has been inspected and approved by MOH, Kazakhstan,

ICBio BA BE facility is approved by CDSCO

Do we need More compensation for Clinical Trials or stop the growing CRO industry?

Do we need More compensation for Clinical Trials or stop the growing CRO industry?

 “The number of trials has reduced considerably because of the Supreme Court’s intervention. Also there is greater compensation,” according to me “Patients will now get at least four times more than they would have got before.”

The health ministry is currently working on a clinical-trial policy that will incorporate quicker approvals and balanced compensation guidelines. “The baseline figure of 800,000 rupees (US$13,000) as per the formula can result in actual compensation of 400,000 rupees (US$6,500) for patients over 65 years old with a short period of expected survival and a maximum of 7.29 million rupees (US$0.1m) for young volunteers in phase 1 trials. Earlier, the compensation was 50,000 rupees (US$800) with a maximum of 300,000 rupees (US$5,000),” he says.

However, determining the cause of death is dependent on the integrity of the investigator: “There are over 30,000 investigators in India — how many are honest and how many are corrupt?” No sponsor would like to publicise unfavourable results, according to me, and there is a conflict of interest because investigators are employees of the sponsor and would find it difficult to file an adverse report. “There is no independent mechanism,” .

Pulling out

Given the uncertain regime, drug companies and CROs are cutting back on clinical trials in India. The Indian Pharmaceutical Alliance (IPA), which represents leading domestic pharmaceutical companies, says that the increasing reluctance of India’s drugs and devices regulator to grant approvals for new drugs, even if they are approved in developed countries, and to allow clinical trials or biostudies for export purposes, has severely hampered the industry.

The hub appears to have shifted to China, where a lot of government support has come to the aid of the industry, in terms of easier processes

Francis says that some trials have moved to other countries. “The hub appears to have shifted to China, where a lot of government support has come to the aid of the industry, in terms of easier processes. English has also been made mandatory in China, which has given a fillip to most CROs to take on work from multinationals.”

it is easier to conduct business outside India. “CROs in Turkey, Indonesia and Malaysia are flourishing, since the regulatory norms are not so strict and approvals are given faster,” adding that CROs in Eastern Europe have made it cheaper to carry out clinical trials there.

“From 2010–2011, things have changed quite drastically for CROs. These regions [Eastern Europe] used to charge heavily, so many of the multinational companies moved to India, where it was 40% cheaper to conduct trials and there was a ready demographic,” she explains. “Now, the margin has come down considerably.”

The effects of the regulatory uncertainty are already being felt. Max India, for example, has announced that it will sell its clinical research business for US$1.5m to JSS Medical Research, a Canadian CRO. The company says the regulatory challenges have made it difficult to scale up the business.

Other Indian pharmaceutical companies, such as Biocon, Alembic, Zydus Cadila, Torrent and Lupin, have already moved trials out of the country. At Biocon, the research and development (R&D) spend is 134% higher in the second quarter of 2015 compared with the same period in 2014. The company’s chairman, Kiran Mazumdar-Shaw, said at an analyst briefing that the high R&D spend is a result of ongoing global clinical trials that require large investment. For example, Biocon’s global phase III trial for biosimilar trastuzumab is being conducted in Europe.

Indian CROs, started moving out to other Asian countries, including Malaysia and Thailand, Since there is a high degree of uncertainty in India has discouraged clinical trials.

ICBio Institute for Clinical Research

Career Opportunities in Clinical Research

ICBio Institute for Clinical Research

Compensation for Clinical Trial-related injury

methodology recommended for computing the compensation. We illustrate this by computing the sums to be paid under various assumptions, and then discuss the ethical dilemmas involved.

Formulae for computing compensation

The guidance recommends the following formula for computing compensation for a trial-related death (C1):

C1=A x B(1-F/100)

In this formula, 'A' is 50% of the participant's monthly income; this represents what the participant would be contributing to his/her dependents. If the monthly income is less than what it would be with the legal minimum wage, or if the participant does not have any monthly income, 'A' will consist of the legal minimum wage (calculated monthly).

'B' is a multiplier that is given and varies with the age of the research participant. In this case, age is taken as the age of the research participant at death or disability.

'F' is the seriousness or severity of the participant's disease at the time of recruitment into the trial. The compensation for a participant with a disease is computed as a fraction of what would be due to a healthy individual; for a healthy individual it would be 'A' x 'B' alone.

'F' is to be determined on a scale of 0 to 100, where '0' represents "no deviation from good health" and '100' represents death. The study investigator is required to set the seriousness or severity to this scale, while ensuring that the most serious or severe condition is not set at more than 50%. This means that even for participants for whom death is imminent due to an underlying health condition, the seriousness will not exceed 50%.

To determine compensation for injuries (C2), the guidance suggests the application of a different formula:

C2=A x B(1-F/100) x D/100

Here, 'A' is 60% of the participant's salary, representing the contribution for his/her dependents. 'B' varies with age, as it does in the formula for computing compensation for a participant's death. 'F' is the seriousness or severity of the disease at the time of participation. As the formula estimates the compensation for injuries and not death, another variable, 'D', is included: the percentage of disability caused to the participant due to trial participation. It is not clear how this is to be determined, but perhaps this is left to the ethics committee.

An alternative suggestion for estimating compensation

An attempt to mathematically compute the quantum of compensation has the potential to reduce a morally compelling act to one of administrative largesse, with attendant clerical rather than moral responsibility. It would be more advantageous and ethical to provide guidance to IECs on how to make this determination along the lines of what other countries have done (12) and leave the responsibility for determining the exact amount of compensation to them. The guidance could list the various criteria that need to be used and the rationale for these criteria, and the potential for trade-offs across criteria. Some possible criteria would be the extent of handicap in everyday social and professional life experienced by the participant as a result of the disability, the number of dependents and their characteristics, and so on. This would provide the flexibility required to manage the known criteria, and any others that may be recognised by the EC while undertaking this exercise. If such general guidance has served well in the determination of potential risks and benefits (which to this day have not been converted to an exact measurement of a net risk-benefit ratio), it would serve to determine a just compensation for a life lost or disabled. It has the potential to make ECs more meticulous in their engagement with research protocols. In the long run, one hopes that it would serve us to make death or disability due to clinical trial very rare for a participant.www.icbiocro.com

Clinical Research in India

Clinical Trial Supplies Market by Products & Services

Clinical Trial Supplies Market by Products & Services (Logistics & Distribution, Manufacturing, Packaging and Labeling), Phases (Phase I, Phase II, Phase III) & Therapeutic Areas (CNS & Mental Disorders, Cardiovascular, Oncology) - Global Forecast to 2020



The global clinical trial supplies market is expected to reach USD 1,274.3 Million by 2020 from USD 904.3 Million in 2015, at a CAGR of 7.1%. The global clinical trial supplies market is broadly classified into manufacturing services, packaging and labeling services, and logistics and distribution services. The logistics and distribution segment is expected to account for the largest share of the global clinical trial supplies products market in 2015.

read more about Clinical Trial Supplies

Wellness Supplements Market by Product (Dietary Supplements (Vitamin, Mineral, Protein, Herbal), - Global Forecast to 2020

Wellness Supplements Market by Product (Dietary   Supplements (Vitamin, Mineral, Protein, Herbal), Functional/Fortified Food & Beverages, Food Intolerance (Gluten-Free, Lactose-Free), Dermo-Cosmetic Skin Essentials (Anti-Acne)) - Global Forecast to 2020

The global Wellness Supplements market is expected to reach USD 249.4 Billion by 2020 from USD 183.1 Billion in 2015, at a CAGR of 6.4% during the forecast period. The growth of wellness supplement is mainly driven by factors such as rising geriatric population, growing prevalence of chronic diseases, rising awareness about benefits of wellness supplements, rising healthcare costs, and shift of consumers from care to preventive. However, regulatory compliance is likely to restrain the growth of wellness supplement market to a certain extent.