Category Archives: clinical research associate job

Apple Plans Transform HealthKit From Tracker To Diagnosis Tool

Apple Plans Transform HealthKit From Tracker to Diagnosis Tool

Till date Apple’s HealthKit has mostly collected fitness data from its devices. In the future, if the company finds its way, the software will interpret that information, converting it into advice for users, doctors and others.

Many health care experts hired by Apple in recent years are designing enhanced electronic health record software that can well analyze and understand the implications of patient data.

The iPhone manufacturer is even working on new apps for the Apple Watch. It can track users’ sleep patterns. Another app focusses on fitness levels by calculating the time taken for the heart rate to fall from its peak to resting level. Apple already has an app that measures heart rate, but yet don’t interpret them.

The ultimate goal of Apple’s health care technology team is to turn HealthKit into a tool that improves diagnoses. The system could do away two problems that plague the field of clinical research and have stumped other specialist firms in the field.

Chief Executive Officer Tim Cook wants Apple to act more in improving software and services to secure new sources of economy and make customers more dependent on the company’s devices.

In early this year, Apple bought Gliimpse Inc., a startup that build software to pull electronic health records from different databases and in different formats and finally store them in one place.

He equated the product to Apple’s music business. That negan with the iPod, but as more people became habituated to storing all their music files digitally, Apple united all music lovers in a single platform on top of the device.

Apple health software might become a revenue driver, too, by keeping people intrigued to the company’s equipments. If a patient’s health records, and related suggestions, are reachable through Apple’s system, it would be difficult to trade in an iPhone for a smartphone running Google’s Android OS, and its health-tracking software Google Fit.

The second module of Apple’s Watch has a built-in GPS tracker, faster processor and is water resistant and many people can run, swim and do other exercise with the device. The upgraded Watch software, dubbed watchOS 3, puts health tracking information more prominently in the user interface, and adds a breathing during exercise app as well as tracking during swimming.

Building more sensors into the Watch serves a limited purpose. The accelerometer can generate most of the useful data needed to monitor a person’s well-being. A glucometer or blood-pressure sensor would only help a small percentage of users, the person said.

Scott Jenkins, said that Apple is working hard with many of these large institutions to produce tools that are medically significant, to take data from sensors.

Stephen Friend, a Merck & Co. veteran who founded health data non-profit Sage Bionetworks, is honored with being the brains behind ResearchKit. He joined Apple as full-time employee in June after working as a consultant for more than two years.

Yoky Matsuoka, formerly technology chief at Google’s Nest Labs unit, joined Apple’s health team last year. Nest mostly known as a hardware specialist, but Matsuoka head the development of software that interpreted and learned from data that its internet-connected thermostats collect.

Apple’s greatest obstacle for now is proving to medical professionals that data delivered from wearables through HealthKit and ResearchKit is reliable.

In the competition of many organizations CRB Tech Solutions developed a big name. Its better known in providing the best training in Clinical Research.

Clinical research jobs are increasing and to meet the increasing requirement of the peofecient professionals , you should consider improving yourself with our clinical research training program.

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

Related Topics:

1) Top 10 Clinical Research Companies in Pune

2) Clinical Research Organization

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Digital Health

With digitalization is its development, the field of clinical research introduces a new word to the list. Yes we are talking about Digital health which is the way by which digital and genomic revolutions converging with healthcare and society. Digital health is enabling people to a better track and improve their own and family’s health, live a better life, more productive lives and improve the society.

Now what is the scope of digital health? It has a broad scope that includes health information technology (IT), mobile health (mHealth), wearable devices, telemedicine and telehealth and also personalized medicine.

Other usage of digital health in their efforts to:

  • Lessen inefficiencies,
  • Enhance access,
  • Lessen costs,
  • Improve quality,
  • Make personalized medicine for patients.

Patients and consumers can use digital health to manage and keep a track of their health and wellness related activities.

The use of technologies such as social networks, smart phones and internet applications is not only changing the way we communicate, but is also providing novel ways for us to supervise our health and well-being and giving us greater access to information.

Why is FDA focusing on Digital Health?

Many medical devices now have the ability to connect to and communicate with other systems or devices . FDA approved devices are are being updated to add digital features. New devices that already have these capabilities are now explored.

Many stakeholders are involved in digital health activities, including patients, researchers, health care practitioners, conventional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.

FDA’s Center for Devices and Radiological Health is overwhelmed about these developments and the combining of medical devices with connectivity and consumer technology. The following are the topics in the field of digital health on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:

  • Mobile medical apps
  • Wireless Medical Devices
  • Health IT
  • Telemedicine
  • Medical Device Data Systems
  • Medical device Interoperability
  • Software as a Medical Device (SaMD)
  • General Wellness
  • Cybersecurity

How is the FDA developing Digital Health?

CDRH has established the Digital Health Program which tends to protect and promote public health and provide continuous regulatory clarity by:

  • Encouraging collaborations and increasing outreach to digital health customers.
  • Creating and implementing strategies and policies for digital health technologies.

Federal Trade Commission Mobile Health Apps Interactive Tool

If you are designing a mobile health app that collects, creates, or shares consumer information, click on the button to take you to the tool on Federal Trade Commission’s website to find out when FDA, FTC or Office of Civil Rights (OCR) laws apply:

Genomics and Genetics

According to J. Craig Venter, digital health is basically a DNA-driven software device and there is no difference between digital code and genetic code. Digital code is a binary code: 0, 1. while, genetic code is a four-base code: A, C, G, T. There can be no conversion between the two as well as digitized man, as Topol defines it in expanded terms.

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

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

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

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

1)5 Ways ResearchKit Is Revolutionizing Clinical Research

2)Crowd funding In Clinical Research

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Rise In Mercury Brings Down Swine Flu Cases

Rise In Mercury Brings Down Swine Flu Cases With the soaring temperatures, swine flu cases which makes people in majority vulnerable seem to have subsided. Only a few patients are tested positive for the H1N1 virus out of total patients who took admission in hospitals.

Dr Charan Singh, nodal officer for swine flu in the Health department in the capital, said that every year, with a rise in temperatures, the virus tends to recede. Hence there are fewer cases now. Cases would have come down more but owing to the unseasonal rains, some cases yet exist.

As per reports of 2015, since January 1st , 4,266 patients tested positive for the virus in Delhi with 1,500 being reported in the month of March. There are reports of twelve deaths from the capital, including two pregnant women and one child.

Health officials told that required arrangements for swine flu, including treatment and diagnostic facilities, will be kept functional till the cases subside completely. Isolation wards remain closed from April-May, but that time it was kept open. An official reported that doctors are expected to continue with treatment guidelines of category A, B and C patients. The nodal officer said that in most of the cases, patients have been suffering from conditions mainly diabetes, heart and respiratory diseases.

As reports of an official from the Union Health Ministry, the year 2015 also saw majority number of deaths and huge number of cases as per reports in the last 6-7 years. It claimed the lives of approximately 2,200 people and affected another 35,000. While 981 deaths were reported along with 27,236 cases of swine flu in 2009, the disease claimed the lives of 1,763 people in 2010 and affected around 21,000 people. In 2011, 603 cases were reported and swine flu claimed 75 lives while, in 2012 there were 5,045 cases and 405 deaths. Swine flu claimed 699 lives and affected 5,254 people in 2013. In 2014, 938 cases were reported and 218 deaths were caused by the virus.

With advise to the people, Singh said them not to “panic”. He continued ro state that H1N1 is a self-limiting disease and if treated in the early stages, chances of complications are quite less. There are no reasons to panic as most of the cases reported are of seasonal common cold or flu. He added that people should simply maintain routine hygiene. The Health department authorised the private hospitals with more than 50 beds and equipped with ventilators to treat swine flu patients. The new guidelines have included 122 private hospitals to treat H1N1 patients, along with 19 government and seven private ones that was previously designated as authorized centers.

The fact is that as soaring temperature reduce swine flu incidence; rains increase it. The unseasonal spell of rain has come as a dampener for the district officials of health department who were hoping that cases of swine flu would lessen with a rise in temperature. The rains have caused drop in temperature making it favorable for the virus to spread.

Well its clear that the only way the incidence of swine flu remains suppressed is higher temperatures and rains can worsen the conditions.

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

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

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

Related Posts:

1) Stem Cells Therapy- A Hope For  Parkinson’s Cure

2) Clinical Research for Pulsing in Veins

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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.

Related Topics:

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.

Related Topics:

1) Pharmacovigilance: Common terms used in drug safety

2) Pharmacovigilance scope

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TOP 5 Clinical Research Organizations(CROs) In India

Introduction:

The clinical research industry is continuously undergoing a positive development in India. Gradually, the clinical researches are being viewed as drug discovery rather than drug development destination only. At present, many companies are looking for innovations. The famous players that are operating in the nation include MNC CROs which are dominating the country’s market . And, it is becoming important for each and every one of us to know about the popular CROs that are functioning in the nation.

This article would give an idea about some of the famous Clinical Research Organisations in the country.

The CROs that are operating in the country can be divided into two major categories:

  • Global Players with their presence in India
  • Domestic Players

Famous Global Players:

Following are a few of the famous global CROs who are having their presence in India:

Quintiles: Founded during the year 1982 when Dennis Gillings, a London based professor signed his first consulting contract. This company began its global expansion during the year 1987 and in the year 1993, the company made its entry into Asia.

Currently, this company covers the Asian continent by opening its services in around 20 cities including Bangalore, India. In our country, Quintiles has five offices in the below locations:

- Ahmedabad

-Bangalore

- Mumbai

- New Delhi

Quintiles India has the pride of holding some of the best relationships with the leading medical centers as well as with some of the experienced principal investigators.

The key services of Quintiles in India are Project Management, Clinical Trial Monitoring, Site Management, Drug Safety, Regulatory Affairs,Quality Assurance and Pharmacovigilance.

PPD: It is one among the leading clinical research organizations which was founded in the year 1985. This company has its offices in as many as 50 countries with a total number of 84 offices. In India, the company is functioning in the following three locations:

- Gurgaon

- Bangalore

- Mumbai

The clients and partners of PPD include pharma companies, medical device manufacturers, Biotech companies, academic institutions and government organizations.

And, the services that are oferred by PPD are clinical development services,laboratory services, – Consulting Services and making innovation

Paraxel: A premier provider of clinical trial services to the biopharma companies as well as the medical equipment businesses for the development of novel medical therapies across the globe for more than 30 years. Paraxel is operating in India, in the following locations:

- Delhi

-Hyderabad

- Bangalore

- Gurgaon

- Mumbai

- Chandigarh

Paraxel is offering the following services:

- Early phase services

- Phase II-III services

- Peri-approval services

- Post-approval services

- Clinical logistics services

- Consulting services

Famous Domestic Players:

Siro Clinpharm: Founded in the year 1996 by Dr. Gautam Daftary. The company started operating in Mumbai.This company also has its offices in USA and Malaysia. Various services that are being offered by this Indian CRO are:

- Clinical operations

- Clinical data management

- Medical writing

- Scientific writing

-Biostatistics as well as Statistical programming

- Clinical trial supplies

The therapeutic expertise of Siro Clinpharm includes:

- Oncology

- Cardiovascular Disease

- Central Nervous System

- Endocrinology

- Respiratory Diseases

- Infectious Diseases

GVK Bio: This is one among the Asia‘s leading discovery research and development organizations. This company has its global customer base of over 300 satisfied customers. The headquarter is located in Hyderabad. In India, the company is operating in the following locations:

- Hyderabad

- Bangalore

- Mumbai

- Gurgaon

- Ahmedabad

The services that are being offered by this CRO are:

- Discovery services

- Clinical development services

- Formulation R&D

- Manufacturing services

- Information & Analytics

- Integrated programs

Clininvent: Clinivent is the company which was established as the Contract Research Organization that is having great capabilities in the areas of clinical trial and data management. The company is located in Mumbai. The partners of this company are:

- TCG Lifesciences

- LabVantage

- Chembiotek

Various services that are being offered by this Clininvent are as follows:

- Clinical trial management

- Data management

- Pharmacovigilance

- Medical writing

- Quality assurance

- GCP training

CliniRX: CliniRX Tangent Research has been developed as an affiliate of the JK Organization which is a 125-year old entity. The JK Organization has its headquarters in India. Various services that are being offered by CliniRX are as follows:

- Site selection

- Project management

- Monitoring

- Site support

- Medical writing

- Safety surveillance

- Clinical compliance

- Biometrics

The research offices of CliniRX are located in:

- Bulgaria

- Netherlands

- United States

- Israel

In the competition of many organizations in Pune CRB Tech Solutions created a big name. Its very popular in offering the best training in Clinical Research.

Clinical research jobs demands are increasing and to meet the increasing need of excellent professionals , you should excel yourself with our clinical research institute.

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

Related Topic:

1)Clinical Research and Scandals

2)Clinical Trials : In The Clouds

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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.

Related Topics :

1) Top 10 Clinical Research Companies in Pune

2) CRB Tech in Clinical Research: Making a difference

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What Really Happens in a Clinical Lab ?

What Really Happens in a Clinical Lab ? Have you ever wondered what actually goes on inside a clinical research unit? Well this article would give you some insight in general!

The essential aspect of a Clinical Research unit is the laboratory and the lab team.

In the clinical facilities, laboratory experts might be both men and women. They are responsible for protocol review, creating documents for the lab, labeling and setting up all requirements for sample collection, processing them and shipping them to respective labs worldwide, or get them in their own labs if the equipments are available.

They process many samples every month, which includes blood, urine, stool and saliva going through the lab on a daily basis. The busiest hour is during the morning when protocols often dictate tight timeliness for sample collection.

Lab staff must work together with the clinical teams to ensure that blood samples are collected, handled properly and make them to the centrifuge and the refrigerators in time. It is very essential for each and every tube to be labeled correctly and processed promptly.

Some clinical labs, use a Watson sample tracking system, which allows the team to track every single test tube as it is processed through the clinic, into the freezer, and then into shipping. Watson helps the lab teams to create tube labels and barcodes for aliquot tubes, track storage, and create shipping manifests. These ensures that every sample is handled appropriately and quality samples are processed for every study.

All the equipment are calibrated regularly and continually monitored for quality analysis. In some labs, refrigerators and freezers are monitored with a Rees temperature monitoring system, which notes the temperature every 5 minutes and alerts the staff with an email and phone call when temperatures vary from the range.

The clinical staff plans in order to make sure that the thousands of samples are kept straight. Moreover quality control looks over the plans and source documents. Maintaining quality data is the mission, and with a vigilant lab team the mission gets accomplished.

In many facilities, it is open 24/7 with a capacity to analyze over 50,000 study samples per month! There are 15% of resources allocated for R&D, 30+ scientists are dedicated for developing complex methods for small molecules, oligonucleotides, biomarkers, proteins, and peptides.

They also have the scientific evaluation/knowledge to advise sponsors on the appropriate assay platform.

The clinical research labs are proud of the quality and innovative work of the scientists and analysts! They are credited to analyze over 400,000 samples each year and access numerous methods.

Many clinical labs develop robust bioassays for novel molecular entities and commercially available compounds analyzed in various biological fluids and tissues for various animals and humans.

In your University days, the students should try to arrange a visit to organizations and institutes where good clinical research is undertaken. This would add more to your knowledge and also practically help you in pursuing your career. Sometime things are different from what we read in books. A practical hands on in a specific environment would help you to nurture your knowledge and enhance your skill. It would be very exciting and inspiring to watch the experts making plans, playing with the samples and managing a well planned database.

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

Clinical research jobs are rapidly increasing 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.

Related Posts: 

1) How Clinical Research Management Can Help You?

2) Get hired quickly as clinical research professional

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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.

Related Topics:

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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