Category Archives: medical science

Clinical research for Hair Treatment

Clinical research for Hair Treatment

Treatments for the various forms of losing hairs have on moderate success. Three medicines have proof to back up their use in hair thinning locks loss: finasteride, dutasteride and minoxidil. They generally work better to prevent further losing locks than to replenish lost locks.

They may be used together when losing hairs is progressive or further restoration is desired after 12 several weeks. Other medicines include ketoconazole, and in female androgenic hair loss spironolactone and flutamide. Mixtures of finasteride, minoxidil and ketoconazole are more efficient than individual use.

Finasteride

Finasteride is used to treat hair thinning losing locks. Therapy provides about 30% improvement in losing locks after six several weeks of treatment, and effectiveness only continues as long as the drug is taken. There is no good proof for its use ladies.

It may cause man boobs, male impotence and depression.

Dutasteride

Dutasteride is used off label for hair thinning losing hairs.

Minoxidil

Minoxidil, applied topically, is widely used for the treatments for losing locks. It will work in helping promote growth of hir in both individuals with androgenic hair loss. About 40% of men experience growth of hir after 3–6 several weeks. It is the only topical product that is FDA approved for androgenic losing locks.

Ketoconazole

Ketoconazole may help ladies.

Spironolactone

There is tenative assistance for spironolactone ladies. Due to its feminizing adverse reactions and risk of sterility in men it is not often used in men. It can also cause hypotension, hyperkalemia, and cardiac dysrhythmia. Also, ladies who are expecting or trying to conceive generally cannot use the medication as it is a teratogen, and can cause uncertain genitals in infants.

Flutamide

There is preliminary proof for flutamide in women; however, it is associated with relatively high rates of liver problems. Like spironolactone, it is commonly only used ladies.

Certain hair shampoos and conditioners and creams creatively become thick current locks, without having affected the growth pattern. There have also been improvements in the style industry with wig design. The ornament has also been proven a source of emotional support for females going through radiation treatment, with melanoma heirs in one study explaining their wig as a “constant companion”. Other research in ladies have confirmed a more combined psychosocial effect of hairpiece use.

Specialized head tattoo designs can simulate the overall look of a short buzzed haircut. Clinical research management has always a very good scope and you can make your career in this field.

Related Topics:

1)Requirement of Clinical Research Associate

2)What is the responsibility of a clinical research associate?

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What Are the Steps Related to Clinical Assessments?

Clinical assessments are a type of analysis that involve huge numbers of individuals order to test new therapies. Many, but not all analysis, are assessments.

Clinical analysis aim to find out important info in response to any adverse wellness question in a very methodical way. A well designed analysis will provide efficient evidence that can help improve NHS services and therapies and the healthcare understanding of doctors.

To be efficient it usually involves obtaining wellness details from a variety of individuals whose healthcare concerns fit the topic of the study. Where sufferers agree, or “consent”, to join as volunteers, this details might be obtained by:

  • Interviews
  • Questionnaires
  • Tests on sufferers in a healthcare setting that measure the effects of new drugs
  • Using individual records
  • A combination of the above

If you are interested in becoming a individual in research:

You could ask your GP or Advisor to consider any assessments or analysis that you may be suitable for You could check out the web pages for your local Clinical Research Network

You could check out the The UK Clinical Trials Entrance which provides details about scientific analysis assessments running in the UK

The NHS Structure says that your NHS healthcare professional should inform you of any analysis for which you may be eligible. ‘Eligible’ here concerns how you fit the strict healthcare and personal requirements used in the study design for it to work technically.

Think about it for a time that you are a effective psycho therapist. Cynthia comes to see you because she’s having a problem. How do you cure her? How do you even know incorrect with her?

Clinical assessment is a way of identifying and preparing treatment for a individual that includes analyzing someone in order to determine incorrect. There are several kinds of emotional tests, all of which have their own pros and cons.

What’s the point of assessment? To response that, let’s go back to the time that Cynthia walking into your workplace. She informs you that she’s sensation very pressured out and nervous because she keeps failing to remember factors. She used to be really up to the mark, but lately she has problems keeping in mind where she sitting her car or what she did just a couple of moments ago.

What’s incorrect with Cynthia? There are several factors that can cause forgetfulness. The only way that you can find out incorrect with her is to do some kind of assessment. Medical tests help you, the psycho therapist, to know what might be resulting in trouble for your individual. Clinical assessment example can be related to psychology.

Related Topics:

1)Requirement of Clinical Research Associate

2)What is the responsibility of a clinical research associate?

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Stem Cells Therapy- A Hope For Parkinson’s Cure

Parkinsosn’s disease affects the middle aged people and what to be known is that exercise in middle age can prevent the occurrence. Many clinical trials are being carried out to find a definite cure to the condition. One among them is stem cells therapy which seems very promising.

In this blog we narrate the ordeal of a 59 year old man who lived with Parkinson’s disease(PD) for 12 years. Ashok Kumar formerly served as a general manager in a private firm, had been leaving an active and productive life until he was diagnosed with PD. This progressive neurological disorder brought his life to a halt and then followed years of futile treatment and he started losing hope. But then his decision of undergoing stem cell therapy for PD turned out to be one of the most favorable decisions of his life.

Talking about his dilemma , Kumar said that he couldn’t stand, sit or walk. He would fall forward and his body suffered from tremors, postural instability and rigidity. When he was at the verge of giving up his hope of recovery, then Plexus Neuro and Stem Cell Research Centre reignited new hope in his life. The stem cell therapy was initiated and within four months his speech, posture, writing ability and body balance improved a lot and he no longer had to take any medications for PD.

Dr Naeem Sadiq, neurologist and director of Plexus Neuro and Stem Cell Research Centre said Kumar is one of the many Parkinson’s patients who have got successfully treated at the center. They have 25 years of clinical experience in treating neurological disorders and provides stem cell therapy for neurological, orthopaedic and psychiatric disorders and several other incurable diseases.

In the early times, medications and certain surgical procedures were the only treatments available for PD. Though medications is less effective in the long-term and might cause side-effects, surgery is not always feasible or goos choice.

In recent years, application of stem cell therapy for treating PD has become a boon for the patients. Stem cells are like mother cells which originate from the developing embryo and differentiate into different types of cells. They are also named progenitor cells as they create new cells. Dr Sadiq said that in stem cell therapy for Parkinson’s disease, stem cells are collected from the patient’s own bone marrow. The cells are isolated and after lab quality analysis, the isolated stem cells are transplanted into the patient’s body. The stem cells migrate to the affected area of the brain, get attached there and transform themselves into healthy tissue and hence replace the damaged cells.

After this procedure the patient is discharged the next day. Regular follow-ups are important and based on the severity of disease, a patient might need subsequent doses of stem cell transplant. In case of Kumar, two doses of stem cell transplant in four months period worked effectively said Dr Sadiq.

Later stages of Parkinson’s are highly debilitating. With the progress of the disease, dopamine producing brain cells get lost in the substantia nigra region of the brain. Dopamine, a brain chemical that plays key role in regulating coordination and movement of the body. Till date, the exact reason behind the loss of dopamine cells in PD is not well clear.

Early detection and timely treatment of PD is crucial for positive treatment outcomes. The general public lacks awareness of PD. The initial stage of PD usually begins as mild tremors on one side of the body which is either neglected by patients or misdiagnosed.

If you are looking for Clinical research course in Pune, then CRB Tech Solutions would provide with proper guidance. Its one of the best in offering training in Clinical Research.

Clinical research jobs are increasing fast and to meet the requirement of efficient professionals , you should consider improving yourself with our institute of clinical research.

This Clinical Research review will help you in considering a clinical research career in the field.

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1)5 Ways ResearchKit Is Revolutionizing Clinical Research

2)Crowd funding In Clinical Research

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Research Areas in the Clinical Psychology

Clinical psychology research is very significant to the nation’s health and well being as other clinical research. It works in the same way as the same way as clinical scientists try to understand the prevention and spread of different genetic and infectious diseases, scientists conduct rigorous psychological research studies to comprehend , prevent, and treat the human condition as it applies psychologically to individuals,families and diverse communities.

Factual results gathered from psychological research studies help practitioners in developing effective interventions and techniques that clinical physicians execute proven, reliable results that improve lives, help troubled relationships, help addicts, and help manage and treat a variety of other mental health issues.

In order to evaluate this body of research, clinical psychology students must undergo proper clinical research training to make significant professional contributions to the field , staying current and up-to-date with the research taking place at universities and research labs across the world. Doing research, investigating unique ways to understand the human mind, and finding solutions to enrich the lives of all others.

Most of these research studies basically fall within one of three main areas integral to clinical psychology:

Assessment

An important aspect of clinical psychology research, involves assessment – or producing significant and reliable tests. Assessments take the form of written tests e.g. intelligence tests, vocational tests and other tests created to measure aptitude for specific careers, interests, and personality types.

Clinical psychologists interview individuals, review their medical data, and conduct clinical trials as part of the assessment process. A comprehensive assessment approach confirms that psychologists apply the most effective and appropriate psychological treatments and interventions.

Roberts and Hardi stated that measurement of treatment procedures, treatment integrity, behavioral changes, functional performance, objective measurements, change of perceptions, and satisfaction from a variety of sources, follow-up assessment, etc., are needed to finalize the ‘scientific credentials’ of each therapeutic approach.

Diagnosis

After gathering sufficient data, they consult the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), which lists criteria and generalized definitions for mental illnesses and conditions. Categories of symptoms differentiate one mental illness from another, and the basic course of each illness.

Beyond the DSM-IV-R, however, research in the field of diagnosing mental health problems remains one of the most exciting research areas in the field today – thanks to rapid advances in technology. Numerous techniques of brain imaging that map brain structure and function now give researchers “images” of both normal and unusual brain functioning. Scientists are using CT, MRI and PET to come up with greater accuracy in diagnosing various mental illnesses.

Psychotherapies

A set of procedures or techniques that psychological problems, and come up with different ways of thinking, behaving, or feeling – has exploded in popularity since the middle of the last century. Most psychotherapies come within one of the four main psychotherapeutic frameworks:

Psychodynamic Therapy

Psychodynamic therapy discovers an individual’s unconscious, seeking reasons or explanations for the individual’s present behavior. This treatment, also called insight-oriented therapy, attempts to bring underlying factors grounded in beginning life to the individual’s attention, increasing self-awareness and self-understanding.

Psychodynamic therapy originates from Sigmund Freud’s psychoanalysis, making it the most old form of psychotherapy. As a result, a large body of research exists to either help or refute the effectiveness of this approach.

Because the results of psychoanalysis research are difficult to measure than behavioral-oriented therapies, research methodologies and outcomes of treatment have been questioned – especially those of the previous studies.

Psychodynamic therapy requires long-term treatment, sometimes a year or more, also complexing the research process. However, researchers today apply the most rigorous scientific processes, including statistics studies completed over a number of years, to study of efficacy of psychodynamic practice and techniques, and many studies report significant positive outcomes.

In the race of many institutes CRB Tech Solutions has created its own niche. Its very popular in offering the best training in Clinical Research. Our clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing gradually and to meet the emerging need of efficient professionals , you should consider upgrading yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will support and guide you in considering and taking up a clinical research career in this field.

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Hexoskin: Clothings That Records Medical Data

Clothings are sensors in the new age!

Can you imagine that there might be clothes that could record many of the things going on underneath the skin. Bygone are the days when bulky heart rate monitors provided inaccurate information. The newest thing to hit the active wear market is the Hexoskin Smart shirt. A smart shirt that is designed to give a causal person exercising to high performance athletes; lab quality results about their bio metric data.

It measures anything about an individual that includes VO2 max, heart rate, heart rate variability,breathing rate and volume as well as steps, cadence and calories. According to American Council of Exercise, knowing an individual’s target heart rate is significant to understand the intensity level of one is currently working out at.

There are possibilities that a person can easily injure themselves if they are exercising too intense or might wonder why not getting the results they want because the activity is not challenging enough. Hexoskin precisely measures a person’s heart rate, leaving no question or guesswork.

Working of Hexoskin Smart shirt

Sensing elements collect data in the shirt, which is then sent to a small device that is non-bulky and sits pretty well in the shirt’s side pocket. This small device collects all the data and is sent to Hexoskin’s secure storage servers irrespective of whether the user has a smart device nearby or not. Then, an individual can review the data at any convenient time . If there is a phone or tablet in range, the data gets streamed in real time to the device’s display.

Reports says that in the United States over 80% of adults do not meet the guidelines for both aerobic and muscle-strengthening activities. The Hexoskin Smart shirt is a kind of motivation helping adults exercise more, because seeing the results in a tangible way on a tablet or phone can be very helpful in tracking exercising habits. A person can understand where their strengths and weaknesses lie, and in turn, change their workout regime accordingly so they can make the most of their time and begin seeing real results with whatever their goal might be.

Knowing a professional athlete’s statistics has become very important. In words of Haydn Masters they thought the majority of injuries just happened. Now they knows they can prevent them and predict them. He added that with enough data, trainers can even predict what will happen to an athlete based on previous events, preventing possible injuries. This is a valuable device in the world of sports, but it can also help anyone who decides to wear Hexoskin Smart.

The information gathered from the Hexoskin Smart shirt proves to be beneficial when going to the doctor, as the results are so accurate that a medical professional could use those results to a person’s advantage when getting a check-up.

So could this “smart” shirt even help with sleeplessness? The National Sleep Foundation added that exercising regularly makes it easier to fall asleep and contributes to sounder sleep. Amazingly, the Hexoskin shirt and device can also be worn while sleeping, helping the user to better understand their sleeping habits and in turn do some correction if required.

The old fashioned belts and monitors as bio metric tracking systems are a thing of the bygone era. The smart shirt is a completely revolutionary way to track the bio metric data of the human body. Getting the information available in real-time, as well as recorded, makes it easy to understand both an individual’s waking and sleeping hours. The device is beneficial to both the wearer and their physicians and trainers.

In the race of many organizations CRB Tech Solutions has created a big name. Its very popular in offering the best Clinical Research training. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly in Pune and to meet the emerging need of efficient professionals , you should consider optimizing yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will help and guide you in obtaining your clinical research career.

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Bungee Jumping and Clinical Research: All About Quality

Bungee Jumping and Clinical Research: All About Quality

The common concern in both bungee jumping and clinical research is safety and security.

Imagine the thought of jumping face-first off a bridge or a very high platform makes many people nauseous. Yet people opt for it, and do you know that several million successful jumps have taken place since 1980? Experts credit the safety record directly to bungee operators who strictly stick to standards and guidelines, like double checking fittings and calculations for every jump.

The cords also have several safety measures and are put in place before being manufactured.

On the day of the jump, the cords are tested, first manually and then with a bag of weights from the jumping height. Lastly, a pro bungee jumper takes the leap for a final test; risking their life to ensure your safety.

So will you take the leap knowing that your cord wasn’t thoroughly tested?….. A professional has not tested it? Or the test data was compromised?

Same is the scenario with clinical research. The volunteers worldwide take the leap, with a trust that protocols will be followed and that the drug they are taking has been analyzed and approved for them to test it. Consumers trust that when grabbing a bottle of vitamins or medication at the local pharmacy that these products are safe, all required tests have been completed, and the findings have been well documented prior to obtaining approval from the regulatory bodies.

Yet, in their April 2016 draft guidance the FDA indicated that in recent years, FDA has increasingly noticed CGMP violations involving data integrity during 39 CGMP inspections. FDA also added that the scenario is troubling because data accuracy is an important component of clinical trial responsibilities to ensure the efficacy, safety and drug quality and FDA’s ability to safe guard the public health.

Good clinical practice is the basic element in conducting clinical research. According to the FDA,good clinical practice is an international ethical and scientific quality standard for developing, conducting, recording, and reporting trials that involve human participation. And complying with this standard provides assurance that the rights, and safety of trial subjects are protected, being consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical data are credible.

So if you’re bungee jumping , volunteering in a clinical research or taking any medication you need to make sure that you are providing your health to an organization/system that takes data quality and integrity to heart.

So one must be very cautious before enrolling for volunteer service. You should go for organizations whose expertise and commitment are not questionable. It has to be high-quality data and very fundamental in accordance to with both the U.S. Food and Drug Administration and the National Institute on Drug Abuse.

The experienced QA team oversees looks after SOP management, audits, and GLP credit. All studies are conducted for the highest level of safety and compliance because there should be care about the study volunteers….this would eventually help advancing quality global health

There are a few clinical trial organizations in Pune, but CRB Tech Solutions has created it’s own niche. Its known to offer the best Clinical Research training.

Clinical research jobs are increasing fast in Pune and to meet the emerging need of efficient professionals , you should consider improving yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will help and guide you in obtaining your clinical research career.

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1)Clinical Trials : In The Clouds

2)Clinical Research and Scandals

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FDA’s New Regulations For E-Cigarettes Has A New Message For Clinical Research

Owing to the many critical and fatal aspects of tobacco and cigarette, came the existence of E-cigarettes. But are they safer than tobacco? Or a high-tech way to hook a new generation on a bad nicotine habit?

Truth is uncertain!

Research into the side effects of e-cigarettes is far behind their popularity. But want it or not, the era of e-cigarettes is here. It’s a booming, billion-dollar industry…..on route to outsell tobacco products within a decade. The number of teens and twins using these products doubled between 2011 and 2012.

In a historic move, the FDA extended its authority to all tobacco products. This implies they will now be putting regulations on for e-cigarettes, cigars, hookah and pipe tobacco, as well as others.

In a press release, the FDA said that this initiative allows them to improve public health and protect future generations from the dangers of tobacco using through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

The Path Study initiative shows that in 2013-2014, nearly 80% of youth who used tobacco had, in a month’s time, used a flavored tobacco product. This means, that most of the youth who are using tobacco products are using products like hookah and e-cigarettes , which have a multitude of flavor options. Now all states do not regulate the sale to minors, this allows the FDA to confirm the age limit and prevent children and teens from purchasing these nicotine products and make an attempt to stop them from developing a nicotine addiction.

The FDA’s rule also adds the condition that manufacturers of e-cigarette products put on the market after February 2007 must meet the mentioned applicable public health standard set forth in the law and receive marketing authorization from the FDA. This says that the FDA will now regulate the ingredients, design, and health risks to the general public, including youths and non-users.

He FDA Commissioner Robert M. Califf, M.D. said that as a physician, he has seen the devastating health effects of tobacco use and added that at the FDA, they should do their

job under the Tobacco Control Act to lessen the harms due to tobacco. That includes ensuring consumers about the information they need to be aware of before taking decisions about tobacco use and making sure that new tobacco products would come under comprehensive FDA review.

Any a clinical research unit, are committed to support the FDA in their mission to improve public health. Hence, Altasciences’ Vince & Associates Clinical Research has introduced a new, devoted smoking research facility to its campus. That research unit has been created for the evaluation of all types of smoking products, including e-cigarettes. In a report they said that they are equipped for research in smoke cessation, tobacco risk assessment, smoking and nicotine delivery.

Though it might take some time probably in years for the FDA to finalize all of the laws and regulations regarding the testing and sale of e-cigarette products. A clinical study funded by the Health Research Council of New Zealand said that e-cigarettes are as effective as other smoking cessation products;but the research is limited, so organizations like the FDA don’t recommend them yet for that purpose. An exception to this is National Health Service in the UK, which made e-cigarettes a part of their smoking cessation program in January 2016.

Many researches are being conducted into e-cigarettes, and eventually all knows more about their actual risks and benefits. It’s high time to conduct clinical research on e-cigarette such that next generation does not fall in the clutches of a probable fatal trap.

If you are seeking for Clinical research course in Pune, then CRB Tech Solutions has created a niche for itself. Its very popular in providing the best training in Clinical Research.

Clinical research jobs are rapidly increasing and to meet the emerging need of efficient CR professionals , you should consider improving yourself with our institute of clinical research.

The Clinical Research review by CRB Tech Solutions will help you in considering a clinical research career in this field.

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Crowd funding In Clinical Research

Crowd funding In Clinical Research (Part I)

Crowd-funding is gearing significance or can say popularity in the field of clinical research or medical research as a whole.

The crowd funding phenomenon was born about a decade ago, inspired by artists to finance independent films and by charities to keep struggling nonprofits afloat. Venture capitalists and entrepreneurs took the leap to launch start-up businesses. Very recently, a growing number of scientists have turned to crowdfunding as a supplement to government grants.

So how would a researcher start at it?

He pr she should start by selecting a website. But the confusion is that there are more than 800 crowdfunding websites, but only a few are eager for funding scientific research. Some of the sites focus mainly on specific diseases or new drugs, while others opt for young scientists. A number of sites invite clinical trials which have regulatory approval but no capital. The donations might be of any size, when others tend to fund more expensive clinical trials.

The mainstream crowd funding hubs Indiegogo and Kick starter had some limited success with financing science projects,but it’s believable that a separate platform is necessary for medical research.

Indiegogo and Kickstarter were designed for creative artists, and hence worked well for the creative processes.

Perhaps crucially, Luan and co-founder Cindy Wu are young scientists themselves – former University of Washington graduate students .

After a poll the professors found that everyone was irritated with the obstacles associated with the highly competitive funding process which complies 80% of rejected proposals. The irony is that the researcher spends 12 weeks a year writing proposals, and the average age of a grant recipient in biomedicine is 42.

Could crowdfunding transform scientific research?

Theoretically crowdfunding could be a viable model for gearing up funding and media attention for small and early stage ideas and high-risk proposals that the current grant systems offered by many institutions.

It’s absolute that although he sees the crowd funding potential have a much bigger and more transforming impact on medical research.

That was the original platform for value for scientists of all types and backgrounds. But, nowadays, the situation has become so extreme that projects and grants that would fund are no longer getting the backing they actually deserve.

Basically we are talking about the slack and devastation caused by the sequester and budget cuts. The same goes the entire history of federally funded science.

Generally there is a long way to go before crowdfunding can actually match the scale of conventionally funded medical research.

Crowdfunding for medical research has some limitations, though. It lacks the traditional government grants and bears new liabilities. In practice there are very few protections to ensure that donations are spent for the said purposes and that guarantee donor dollars are going to the benefit of science. In case of government grants, university admins carefully review and sign off on applications to ensure the terms of the award can be honored.

The main issue about crowdfunded research is the lack of traditional peer review. It’s extremely difficult to secure the baseline sponsoring that researchers count on, and there is certainly the eagerness of trying creative, alternative sources of funding. The peer review is a good feature of government grants. With clinical research, the government funding infrastructure comes with some basic oversights, safety concerns , internal checks and balances, and continuous follow-up by review boards.

In our next article we would be continuing with the other aspects of Crowdfunding. We would brief about how scientific crowdfunding is different from crowdfunding creative objects. Can Crowdfunding actually transform the scientific research or the clinical research in whole.

Stay connected for more blogs and articles and enhance your knowledge with us.

Are you looking for Clinical research course in Pune, then CRB Tech Solutions would provide with ample help and support. Its very popular in offering the best training in Clinical Research.

Clinical research jobs are increasing fast and to meet the emerging need of efficient professionals , you should consider optimizing yourself with our institute of clinical research.

The Clinical Research review by CRB Tech Solutions will help you in considering a clinical research career in this field.

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2)Clinical Research for Paedophiles

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Clinical Research and Scandals

News about mortalities are rare during a clinical trial, mainly during the initial stages. But in January 2016, six men in France who had enlisted in a phase I trial of a pain relief drug suffered brain damage. One man succumbed.

The report was sidelined saying a coincident.

According to the FDA, there were no clinical trials of the drug in the United States, That does not mean, however, that the U.S. industry won’t feel blow back from the incident that happened thousands of miles away. Indeed, learning from past experiences, the scandal could prompt the FDA to tighten regulations.

In the meantime, FDA regulators began working with their French counterparts in the Agence Francaise De Sécurité du Médicament et des Produits de Santé to apprehend what happened to the six men who signed up to test the drug, goes by the name BIA 10-2474.

A History of Scandals

The last major phase I clinical trial catastrophe in Europe occurred a decade ago in London when six men suffered permanent organ damage, and the loss of fingers, sue to some severe immune reactions during the testing of an arthritis and cancer drug,as per reports.

The main reason of a clinical trial is to give proof to authorities that a drug is safe and effective when used as recommended. Fact is that, many experimental drugs never make a pass through the first stage despite years of testing.

Gagnon said that the French equivalent, the Agence Francaise De Sécurité du Médicament et des Produits de Santé, abbreviated as ANSM, is a very genuine and sophisticated regulatory body. French clinical research organizations have to follow the country’s domestic rules and regulation programs as well as international and European Union regulations. Gagnon added that France and other EU countries are no different from the United States in requiring organizations to conduct proper clinical researches that will be safe for participants. The FDA basically conducts more inspections of sites, manufacturing facilities, labs and companies, mainly because FDA regulators have more resources to do so.

One of the most infamous scandals happened half a century ago and involved a sedative, thalidomide, which caused severe malformations among babies whose mothers took the drug to do away with morning sickness.

Thalidomide, yielded by a West German company and marketed in 46 countries, never made it to U.S. consumers. Frances Kelsey, a FDA drug reviewer said that in next to no time the fighting over the new drug laws that had been going on for five or six years suddenly melted away.

That scandal added another dimension to the review process, according to an account by FDA historian Suzanne White Junod. After thalidomide, drug manufacturers not only had to prove that a drug was safe, they also had to show “substantial evidence” that the drug was effective based on “adequate and well-controlled studies.”

Balancing Risk and Rigor

Today the scale of approval of new therapies has become very high. The FDA holds patient safety as foremost in their review decisions,which helps pharmaceutical and medical device companies meet safety regulations.

In the race of many institutes CRB Tech Solutions has created a niche. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly and to meet the emerging need of efficient professionals , you should consider upgrading with clinical courses.

Clinical Research review by CRB Tech Solutions will help and guide you in considering a clinical research career in this field.

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1) Clinical Research training in CRB Tech

2) Clinical research training course in CRB Tech

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Clinical Trials : In The Clouds

Cloud technology in the life science industry

The cloud system has the ability to ingress important services from everywhere with a level of simplicity. Its flexible and cost efficiency. The cloud gives on demand access to software/applications, platforms and infrastructures commonly known as:

  • Software-as-a-Service (SaaS)
  • Platform-as-a-Service (PaaS)
  • Infrastructure-as-a-Service (IaaS)

Professionals in Clinical trial use public clouds but mostly for administrative, IT, marketing or sales purposes but very few of the cloud services are directly related to health care.

Cloud-based systems are gaining popularity in most of the industries, but the adoption rates for this new technology is very low in the health care sector. Some IT vendors in clinical trials like Medidata Rave are saying that they are offering cloud services, whereas the services rendered by them are neither self-service nor on a pay as you go basis. Not a uncommon scenario though; many organizations exploit the cloud marketing buzz, yet give services that are neither self-service, automated nor cost-efficient.

In clinical research, cloud technologies are a new opportunity to lower the raising costs. Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) or ePRO systems would be configured and implemented at a faster pace and at a lower cost. In January 2012, Forbes calculated the average cost of bringing a novel drug to market at $1.3 billion (at times $4B to $11B for big pharmaceutical companies), this calculation also takes failed drug application in account.

But owing to the automated properties of the cloud, drug development cost is suppose to decrease since clinical researches will be started and ended faster than ever before.

Benefits of running clinical trials in the cloud:

Quick implementation

Users can start building studies and manage data at an instant

Ideal for finite resources and small clinical departments

No programming experience needed

CDASH compliant eCRF library for fast start up

User empowerment

Study builders can configure and deploy studies without dependencies on IT

Self service platform and intuitive drag and drop tools

Instant scalability

CPU cycles , memory and network bandwidth are given at an instant on growing demand

Hardware resources can be instantly scaled down if no longer required

Designed to handle noteworthy data and store the data for real time usage and historical analysis

Lower costs

50% of all businesses use cloud to influence cost efficiencies

Plug and play system: no initial investment required in IT or any device

Summary

  • Implementation time is lessened from 7 weeks on average to 1 week according to ClinCapture’s users.
  • More than two thirds of users claim easy utilization of ClinCapture .They can concentrate on drug development.
  • Cloud-based EDC is perfect for flexibility, scalability, and rapid study start up.
  • Minimal investments for infrastructure maintenance and upgradation.

In the race of many organizations CRB Tech Solutions has created its own name. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly and to meet the emerging need of efficient professionals , you should consider optimising yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will help and guide you in considering a clinical research career in this field.

Related Topics :

1) Top 10 Clinical Research Companies in Pune

2) CRB Tech in Clinical Research: Making a difference

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