Category Archives: clinical research job

Is Clinical Trial A Product Or A Service?

Is Clinical Trial A Product Or A Service? in a recent ACT ‘What do you think?’ survey, readers were asked if a clinical trial is a service or a product. Only 53% of people identified a clinical trial as a service. Other responses included product (7%), neither (20%), or other (20%) with the most common response in the other category being ‘research.’

These responses are quite typical. There is a lot of confusion within the industry about what the value developed by clinical trials – even till the point of knowing whether a clinical trial is a product or service. This confusion degrades value creation, productivity.
Clinical trials are done to collect data regarding the safety and efficacy of new drug and device designinh. There are many steps and stages of approval in the clinical trials process before a drug or device is out in the consumer market.

Drug and device testing starts with laboratory research which can involve years of experiments in animals and human cells. If the initial lab research is successful, researches send data to the FDA for approval to continue research and testing in humans.

Once getting the approveal, human testing of novel drugs and devices can start and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of the phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.

Reasons for Conducting Clinical Studies

Basically clinical studies are designed to add to medical knowledge related to the diagnosis, treatment and prevention of diseases or conditions. Some common reasons for conducting clinical studies are:

  • Assessing one or more interventions for treating a disease, syndrome, or condition
  • Finding ways to avoid the initial development or repearation of a disease or condition. These can include medicines, vaccines, or changed in lifestyle , among other approaches.
  • Assessing one or more interventions aimed at identifying or diagnosing a particular disease or condition
  • Examine methods for identifying a condition or the risk factors for that condition
  • Finding and measuring ways to enhance the comfort and quality of life through supportive care for people with a chronic illness

A clinical trial is a service, as the application of knowledge and skills to benefit another entity. The keyfeatures of services are that they involve delivery processes. Products are goods manufactured basically in a yield setting. It is much easier to measure and organise the yield process of products. Service processes are much more difficult to measure and manage.

This doubt about whether a clinical trial is a service or product also results to lower-quality clinical trials and billions of dollars wasted on ineffectual quality improvement investments. Yet, the industry measures trial quality as if it is a product – leading to mismanagement and low-quality trials. The industry has spent billions of dollars trying to improve the quality of trials in the past years without any improvement in reality. The basic reason is that the industry still hasn’t figured out if a clinical trial is a peoduct or a service .

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

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

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

Related Posts:

1) Why Clinical Trials Are Very Much Useful Through Mobiles?

2) Clinical Trials and Its 4 Stages for New Medications

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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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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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Clinical Research For Physiotherapy

Clinical research is quite vital in the field of physiotherapy. Physiotherapists depends on information from researches to enhance the knowledge they have already gained through their university education and with continuous education courses.

Physiotherapists use the method of “evidence-based practice” as the basis for their treatments; based on quality controlled scientific research and clinical reasoning. Clinical research helps the practitioners keep updated with the latest in practice methods. With the knowledge gained from clinical research, the physiotherapists can explain that the methods CR specialists use to treat our patients are based on empirical evidence, peer review and sound clinical reasonings behind every principles.

There is a great deal of clinical research being performed in physiotherapy nowadays as has been the case for many decades. By regularly update of skills and taking on broad new proof based research, physiotherapists are at the cutting edge of developments in the healthcare sector and the physiotherapist have the scientific evidence to support their treatment methods.

As physiotherapists, they treat a wide array of medical conditions :

  • Spinal pain and injuries
  • Headaches
  • Sports injuries
  • Fractures
  • Musculoskeletal problems
  • Post-surgical rehabilitation
  • Biomechanical problems
  • Arthritic conditions
  • Neurological disorders and diseases
  • Cardiothoracic conditions
  • Paediatric conditions

A few to mention!

Physiotherapists are trained in manual therapy which means they are “hands on” with their patients. In addition to their manual skills they sometimes make use of different ways to reduce pain and inflammation including ice, hot packs,TENS, E-stim, laser treatment and ultrasound. Trigger point therapy and acupuncture is widely practiced by physiotherapists. The physiotherapy experts are highly trained in exercise prescription and often give their patients exercises to practice at home to help resolve their conditions.

The profession addresses neurological,orthopedic and cardiopulmonary problems among people of various age range from infants, children, adults and all populations.

Physiotherapy treatment might involve exercise to improve strength,

motion and endurance range and to correct imbalance of posture and muscle , joint mobilization, manipulation and soft tissue massage, as well as stretching and trigger point therapy to reduce stiffness and to relieve pain.

Patients with neurological disorders such as multiple sclerosis, stroke, cerebral palsy, Parkinson’s disease and spinal cord injury that can benefit greatly with physiotherapy methods. Interventions focus on muscle control, recovery of fine and gross motor skills, improve daily function, regaining of strength and flexibility, restoring and improving gait and training in the use of aids of mobility.

Cardiopulmonary conditions respond good to physiotherapy intervention. Patients who have difficulty performing their activities of daily living, or who have problem with shortness of breath and reduced endurance, can achieve improved quality of life through guided training. Intervention includes manual therapy and exercise to help clear congestion in the lungs, counseling about risk factors, patient education to prevent future occurrence and behavior modification. For those patients who have had cardiopulmonary surgery, physiotherapy is initiated at an early stage to prevent the patient from losing strength and function.

So the clinical trials that are ongoing worldwide, would definitely help with many novel techniques that would be more efficient, patient friendly and less time consuming.

Amidst many institutes in Pune, CRB Tech Solutions has created its own niche. Its very popular in giving the best training in Clinical Research. Our clinical research institute has created a name for itself in this field.

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

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

Related Posts:

1) Clinical Research Organization

2) What is Clinical Research Organization and jobs in a CRO

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Hormone Therapy Side Effects And Management

Hormone Therapy Side Effects And Management are as follows

What Is Hormone Therapy

Hormone therapy is gaining grounds in the are of clinical research , Hormone therapy or hormonal therapy is the usage of hormones in medical treatment. Treatment with hormone antagonists might also be referred to as hormonal therapy or anti hormone therapy.

The general classes of hormone therapy are carcinogenic hormone therapy and hormone replacement therapy, of which there are various kinds (e.g., for menopause,wither male of female or for sex change).

Hormone therapy is a type of systemic therapy that functions to add, block or remove hormones from the body to slow or halt the growth of cancer cells. At Cancer Treatment Centers of America (CTCA), they use hormone therapy to fight various forms of cancer alongside Integrative Oncology Services to fight the side effects.

Hormones are the body’s chemical messengers and are produced in the endocrine glands, which include glands such as the pancreas, thyroid, ovaries in women and testicles in men. Hormones can influence the growth of some cancers, such as breast and prostate. But, in some cases, they can kill, slow or halt the growth of cancer cells.

Hormone therapy generally involves taking medicines that prevent cancer cells from getting the growth hormones. In some cases, the physician may surgically remove the gland responsible for hormone production. The physicians may use hormone therapy in combination with other cancer treatments, such as chemo and radiation therapy.

CTCA clinicians work in concert to give all possible treatment options. The care team would consider hormone therapy as a treatment option if one is diagnosed with breast, prostate, ovarian or thyroid cancers. Several factors influence the type of hormone therapy one might receive, including the age, type and size of the tumor, and the presence of any hormone receptors on the tumor.

Patients are at the center of treatment decisions at CTCA. They understand there are many factors that might influence the treatment option they choose, such as any desire to have children. They listens to the patients and work as a team to develop a treatment plan that could meet individual needs.

General side effects of hormone therapy

The side effects might depend on the type of hormone therapy being administered. Only generalized side effects are mentioned here. More information about the side effects of specific hormone therapies can be obtained in the specific drugs section.

General side effects include

  • Tiredness
  • Digestive system problems
  • Menopausal symptoms
  • Hair thinning
  • Effects on your muscles and bones
  • Weight gain
  • Headaches
  • Memory problems
  • Mood swings and depression
  • Blood clots

Side effects management

Some hormone therapies can cause many side effects, depending on the type of cancer involved. For example, breast cancer patients may experience dryness and irritation, hot flashes, vaginal discharge, decreased sex drive; and mood changes.

Prostate cancer patients might experience reduced ability to achieve an erection or orgasm. Aromatase inhibitors also can cause joint and muscle pain, and an increased risk of bone thinning i.e. osteoporosis.

Throughout the entire treatment, the patient would be provided integrative oncology services to help combat these side effects. Nutrition therapy,naturopathic medicine,mind-body medicine and spiritual support can help reduce side effects, as well as improve the overall quality of life.

In the race of many institutes CRB Tech Solutions has created its own name. 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 help and guide you in considering and taking up a clinical research career in this field.

Related Posts:

1. How Clinical Research Management Can Help You?

2. 5 Clinical Management Factors to be Discussed

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Medical Research: Rebuilt, Retooled and Rebooted

Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile medical device company developing a human-centered suite of consumer products using science and technology to empower everyday people to monitor and better understand their own health—anytime, anywhere.

The traditionally conducted clinical trial models need increasing amount of time, cost, and resources for both sponsors and sites. Only fewer than 10% of clinical trials are completed on time due to poor patient recruitment and budget negotiations. Since 2008 per-patient, clinical trial costs in the US has raised by an average of 70% across all growth phases.

In March 2015, BLOOMBERG BUSINESS reported that Stanford University scientists were stunned when they awoke Tuesday 10 March to find that 11,000 people had signed up for a cardiovascular study using Apple Inc.’s ResearchKit within less than 24 hours, after the iPhone tool was introduced.

Fact says that to get 10,000 people enrolled in a medical study normally would take a year and 50 medical centers around the country……That’s the power of the smartphone…..smart technology!

Rebuilt

At Scanadu, data collection and clinical studies are key to the development and deployment of medical devices. And as a startup developing the next generation of medical devices for consumers, they had to innovate the clinical study process, while defying the traditional assumptions related to a clinical study.

In May 2013, they initiated the most successful crowd-funding campaign for a medical device on Indiegogo , because they wanted to standardize this campaign and its platform to put together their FDA study. Over 8,000 people backed the campaign.

They associated with Scripps Translational Science Institute (STSI) and, after cautious preparation, officially launched the SCOUT study for the investigatory medical device in early 2015.

STSI is now conducting a completely mobile-based trial analyzing the impact of the Scanadu Scout, the first comprehensive, handhold, wireless device designed for personal use, measuring core body temperature, blood pressure, oxygen saturation and heart rate. The study aims to understand how the device improves health behaviors in participants and to evaluate the ease of use and acceptance of the technology.

Retooled

All platforms were HIPAA-compliant, all content was Institutional Review Board (IRB) approved and an electronic informed consent form was used. More than 75% of all backers based in the US signed up for the study, and in the latest survey more than 90% of them expressed that they would be willing to participate in such a study again.

Anyone who enrolled in their study – or is currently using Research Kit in a study such as GlucoSuccess, Asthma Health, Parkinson mPower, or MyHeart Counts – will definitely agree that using an eICF presents many opportunities and advantages for both sponsors and participants.

Using a HIPAA-compliant platform for the ICF process has eliminated major problems including missing or incorrect signatures and dates or lack of verifications. However, using this type of platform for eICFs did have some hurdles. While this particular digital signature platform was user-friendly for the most part, not knowing all of the details of sending the documents led to some confusion for some recipients. This led to a pause in enrollment for a few days and resending some ICFs to potential subjects. No system is totally flawless and during enrollment there were technical glitches that caused a change in expiration dates on the documents.

Rebooted

The SCOUT study has an unequaled enrollment rate for a medical device, and while there were challenges, this success is due to the transparency of the process, the incredible engagement from the participants, and the full use of today’s technology .

Access to information, knowledge and rapid development of technologies has an unequaled impact on the progress of science. If many people participate in clinical research trials like this then mode development can be made in the field of Clinical Researches.

Among many institutes and organizations our CRB Tech Solutions has created a niche in providing Clinical Research Training.

The Clinical Research review by CRB Solutions is sufficient to make you consider and take up a career in this field.

Related Topic:

1) Clinical Research: Duties of a CRC

2) Why Clinical Research?

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A Life Lab For Clinical Research

A Life Lab For Clinical Research ORCATECH is an R&D center formed in combination with the biomedical engineering and neurology departments at Oregon Health and Science University.

Judith Kornfeld, the chief business and operations officer for ORCATECH and her group has developed a system for clinical research which is based on remote sensing and pervasive computing where data is collected unnoticed and continuously. ORCATECH installs sensors in patient homes, rather than equipping patients with wearable devices, to monitor patient activity.

This article summaries Judith’s opinion on how technology is transforming clinical development.

ORCATECH’s technology

ORCATECH technology was developed to allow the patient’s daily life to be the source of data collection to measure health changes and meaningful outcomes in clinical studies.

Moreover, this approach to clinical trials need a smaller sample size per clinical trial and the ability to detect changes and response to therapy is much faster owing to the density and the plurality of the data.

What are some of the types of data you’re collecting?

Movement around the house

Leaving and entering the house

Walking speed, sleep measurements

Computer use

Balance, weight

Driving parameters as well

Medication use

Socialization and more

Even weekly reports are collected via E-mail that allow to obtain additional data that was not picked up through the automated system.

Indeed a dense data

Since it’s continuous and mostly collected 24/7; clinical data management has to be very efficient.

Too much of potential data

In response Judith said there is nothing really “too much data,” it’s all about how make sense of this gold mine. It’s the algorithms developed here that take all this data and interpret it into valuable clinical information.

Digital biomarkers

Humans are digital markers and information can be obtained in a very accurate manner that reflect the patient’s parameters of real life.

Digital biomarkers are a fairly new concept to be considered in pharma technology?

The whole idea is to collect something that is ecologically valid. There won’t be use of a single device and follow one data stream that is isolated from reality. The approach should make sense and gives a multidimensional picture.

Future of drug development with this new technology

The whole design of the clinical trial has to change.

There are plenty of compounds but very few gets approved. The clinical trial process is very costly, long and inefficient…..This has to change.

Along-with the drive to reduce costs of health-care efforts must be undertaken to reduce the cost of R&D for treatments, both pharmaceuticals and medical devices.

New technology can reduce costs

In terms of technology, the cost of implementation and efficiency of the clinical trial process this new technology may reduce costs in many ways.

The sensors are off-the-shelf sensors that are very inexpensive. Since no development of any special devices, so no development costs. Even the fact that data collection takes place in home and not in an expensive clinical setting reduces costs.

But the real cost advantage occurs in the long term, because small sample size and shortened clinical trials would lead to significant costs savings.

Even time in a trial is very expensive, so if the time required can be reduced this would the cost enormously.

Most talked concerns about with this type of technology

Security and privacy, though none of the data collected can identify a person. No cameras or facial recognition device used and all the sensor data that is collected in the home is separated from the identity of the subject.

Since all our lives today are on the Internet, so the idea of data collection at home is no more a privacy breach. Judith said that they comply with all HIPAA standards and use IRBs in all research works.

Clinical Research review by CRB Tech Clinical Research training is sufficient to make you consider and take up a career in this field.

Related Topics:

1) Clinical Research for Pancreatic Disorder

2) Clinical Research for Obesity

 

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6 Ways ResearchKit Would Change Clinical Research

6 Ways ResearchKit Would Change Clinical Research Many of the smartphone users tracking things like steps, meals, sleep, medication, weight and menstruation as second nature. And for researchers who rely on data like this to study everything from chronic ailments to healthy lifestyles, all of that information has been going to waste for years, locked away in the some data clouds of telecommunication companies.

Last month, Apple launched ResearchKit, a software framework that would allow developers to use the iPhone as a diagnostic tool for medical research. It launched with five applications to study diabetes, breast cancer, asthma, cardiovascular disease, and Parkinson’s disease.

Do you wanna learn more about ResearchKit ? The article will provide you in precision 6 ways by which it would bring changes in clinical research. Here’s how ResearchKit would revolutionize the medical research space:

1) Access to precise data

More data means more findings that can help more people. Since data collection has taken place since many decades ago, the robustness of the collected info is not that easy to be inferred.

If ResearchKit’s apps allure even a tiny fraction of smartphone users to enroll in a study, the strength of the data and the ease to infer them,would dwarf anything that even the most robust scientific population studies have provided.

2) Integrity in diversity

The iPhone users will be way more diverse than the general kind of people traditionally participate in clinical trials and studies

With the usage of Apple’s ResearchKit, the experiments can be diversely integrated say in terms of participants or monetary issues or time and transportation..

With the Apple’s design, enrollment would become easier and informed consent seems to be more friendly, which lowers the barrier of more people being wiling to sign up for research.

3) Accuracy in health information

As of now, most studies about exercise and heart health are reported by the subject, using their own recall. This app would make it possible to record when participants were sitting around, walking, or being moderately active.

4) People can choose to contribute to the field of research that affects them most

The five apps launched with ResearchKit target people with heart disease, asthma, Parkinson’s disease, diabetes and cancer; which means that iPhone users may be motivated to enroll and gain insight on the chronic disease that affects their lives.

5) Democracy in scientific researchers

Experts believe that the platform’s open source development will mean that research institutes will be able to more easily learn from one another and collaborate, instead of repeating each other’s steps due to competition. It could also have the effect of drawing the general public into a collaborative and open research community.

6) More work in lesser time

The entire pipeline of research starting from data collection to publicly published results to advice for individuals ,will shorten substantially.

The announcement of Apple’s Senior VP of Operations Jeff Williams created ripples in the scientific community. The software gives a platform to developers for apps that collect health data and create programs that can help users improve their health. In addition of providing benefits to iPhone users who simply want to have knowledge of all the health data they’re tracking, the new software gives researchers a scope to access the millions of bits of health data on users’ iPhones.

The future of clinical research is uncertain but the first 10 months of ResearchKit provide some amazing clues. If these changes become prevalent, our CR model will look quite different.

  1. Easier Recruitment, Harder Retention

  2. Participatory Research

  3. A Learning Research System

  4. Convergence of Research & Care

  5. Multi-Dimensional Health Insights

ResearchKit apps have largely been used for “minimal risk” observational studies. While testing a new drug, regulations are very stringent, responsibilities are greater, and risks are higher.

Clinical Research review by CRB Tech Clinical Research training is sufficient to make you consider and take up a 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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Top 10 Clinical Research Interview Questions

Top 10 Clinical Research Interview Questions that’s frequently asked are as follows

(1) What is  Clinical trial

  • Clinical trial is a health related research study in human following a well defined protocol. It includes both intervention and observational types of studies. In intervention study the research subjects are assigned by investigators for a treatment and outcomes are measured. While in observational study an individual is kept under observation and outcomes are studies by an investigator.

(2) Why participate in a clinical trial?

  • Participants play important and active role in their own health care and can help others by contribution in research.

(3) As a researcher what is your best skill?

  • Analytical, Communication , supervisory , good clinical practice skills, trial initiations and formation of design protocol

(4) What does  Clinical Research constitute of ?

  • Clinical research is an attempt to invent a new drug or molecule against a particular diseases . It comprise of looking after since the inception of the drug still its market release and supervision of any unexpected side effects.

Top_10_Clinical_Research_Interview_Questions

(5) Did you face any workplace conflict? If yes! How you handled?

  • First I try to access whose fault is it , mine or others. If it’s mine, I apologize and don’t repeat. It its others then I point their fault or or else ignore if not of major concern.

(6) Outline some familiar therapeutic areas.

  • Oncology and neurology

(7) What would be your dream project?

  • My dream project would be monitoring a new trial being conducted in a different base exclusive very underdeveloped countries.

(8) Tell the advantages and disadvantages of a large independent department of psychology and psychology as a multi disciplinary team.

  • An independent department can have a wider scope of experience in the field of psychology than a multi-disciplinary team, but the multi-disciplinary team would be able to look at the patient more wholly in terms of mind body relationships.

(9) Say about your strengths and weaknesses.

  • Strength: I’m industrious and performs optimally even under pressure.

Weakness: I’m a perfectionist.

(10) Share your most fascinating experience in your research

  • During my degrees, I developed a research proposal to research the ethics the ethics committee as part of my dissertation. I found it fascinating that during my study I had a through understanding of literature review and could recognize gaps in current knowledge base.

(11) What type of research interests you ?

  • Patient-Oriented / outcomes and health services research

(You can share any experience)

CRB Tech Solution’s Clinical Research review is sufficient to make you consider and take up a career in this field.

Related Topics:

1) What is the Role of a Clinical Research Coordinator?

2) What is The Clinical Research For Cancer?

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