Category Archives: clinical research organization

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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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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Impact of GST on Pharma Industry

Impact of GST on Pharma Industry 

The news is that finally the long-awaited Goods and Service Tax Bill (GST Bill ) has overcome the hurdles of both the houses in parliament. A turning point it is for the country because it will not only make the method of taxation easy to understand but also lessen the malpractices that have been prevalent due to obscurity and confusion of tax norms.

The GST regime is supposed to bring a great boost to the pharma industry by making the supply chain management efficient and lessening the cost of manufacturing pharmaceutical products. The reduction in the costs will be of added value to the profit margins which is a good thing for the manufacturers.

As the bill has gone through various rounds of discussions and it was under consideration for more than two years, it is obvious that it has come out as the well planned bill and now the government is determined to make it a success by taking all the necessary ways. Now the constitutional difficulties are issue of the past, and the corporate world is gearing for understanding the possible effect of GST on the business.

What all will be included in GST?

Though the basic objective of implementing GST is to about eliminate the long list of taxes and levies. It is a route towards easy and manageable tax liabilities. GST is expected to lessen following tax burdens at the state and central levels.

Central level taxes

Service tax,countervailing duty, central excise duty, additional excise duties, special additional duties of customs, and excise duties under the medicinal and toilet preparations Act of 1955 will get abolished by the new system. Also, extra charges on the supply of services and goods will also get removed.

State level taxes

CST, Entry tax, purchase tax , sales Tax and VT at the state level,luxury tax, State level entertainment tax, taxes on lottery and gamble will be included under the GST head. Also, surcharges on the supply of goods and services at the state level will also get abolished.

Specific impact on the pharma industry :

  • Under current system, specific API or life-saving drugs has the benefit of non-levy of excise duty if they are included under some specific notification of the Central Excise Law. Now the Central Excise Duty will get merged in GST, and hese life-saving drugs will gain the Tax-Free status. The previous goods will also enjoy exemption from IGST in case they are imported.
  • Even it will be quite interesting to know about the translation of the collection of credits when GST is applicable. Since pharma companies give a high stack into it, the impact will be wholesome.
  • In the existing model of Indirect Tax law, supplies made to a loan licensee enjoy exemption from VAT. It is important that the industrialists get the clarity about the situation post-GST implementation. Also, currently there is no service tax on the processing charge paid to the loan licensee because the process comes under “manufacturing process”.
  • Though the proposed bill says that the existing advantages will be continued, it is very much crucial that business owners make the situation clear.

In the race of many organizations CRB Tech Solutions has created a big name. Its well known in offering the best training in Clinical Research.

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

Clinical Research review by CRB Tech Solutions will help 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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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 And Its Types

Clinical Research And Its Types Clinical Research is a booming industry of today’s time. Based on topics or area of interests, there are different types of clinical researches. Here we write about some different kinds of clinical research.

Clinical Trials
Generally involves psychotherapy, medication, new devices or new approaches to surgery or radiation therapy.

Prevention research
It investigates better ways to prevent disorders from developing or returning. Different types of prevention research might study vitamins, medicines,vaccines, minerals, or lifestyle changes.

Diagnostic
They looks after practicing better ways to identify a particular disorder or condition.

Screening
This aims to find the best ways to detect certain disorders or health conditions.

Genetic studies
This research aims to improve prediction of disorders by identifying and learning how genes and illnesses might be related. Research in this area might explore ways in which a person’s genes make him or her more or less susceptible. This could help in l development of tailor-made treatments based on a person’s genetic make-up.

Epidemiological studies
This helps to identify the causes, patterns and control of disorders in groups of people.

Note: Some clinical research is “outpatient,” which means participants does not need to stay overnight at the hospital. Some is “inpatient,” meaning that participants will required to stay for at least a night in the hospital or research center. You need to be clear about what the researchers and their study requires.

Clinical trials phases: when clinical research is used to evaluate medications and devices
Clinical trials are a kind of clinical research
programmed to assess and test new interventions such as psychotherapy or medications.

Clinical trials are done in four phases. Each phase has a different purpose and help scientists answer different questions.

Phase I trials
Researchers
experiment a novel drug or treatment process in a small group of people for the first time. The researchers try to find the treatment’s safety, determine a safe dosage range, and identify if any side effects.

Phase II trials
The experimental
medicine or treatment method is given to a bit larger group of people to see it‘s effect and hence further assess its safety.

Phase III trials
The experimental
novel drug or treatment method is given to large groups of people. Researchers confirm its effectiveness, supervise side effects, compares it to normally used treatments, and collect informations that will permit the experimental drug or treatment method to be used with safety.

Phase IV trials
Post-marketing studies are conducted after a treatment
gets approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research
It’s a general belief that, all clinical research involves testing of new medications or devices. Well this is not the case always. Some studies does not involve testing medicines and a person’s regular medications might not need to be changed.

Healthy participants are also needed such that researchers can compare their results to results of people with the illness under study.

Some instances of other kinds of research include the following:

  • A long-term study which involves brain scans or psychological tests
  • A genetic study which involves blood tests but no changes in treatment methods
  • A study of pedigree that involves having words with family members to learn about people’s medical needs and history.

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

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

Our Clinical Research review will help you in considering a clinical research career in this field.

Related Posts:

1) What Are The Types of Clinical Research?

2) Clinical Research Company

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5 Ways ResearchKit Is Revolutionizing Clinical Research

5 Ways ResearchKit Is Revolutionizing Clinical Research  With its launch, Apple’s ResearchKit has achieved some impressive milestones:

  • More than 100,000 people signed up to take participation in ResearchKit studies
  • Companies like Quintiles and Medidata gave some enhancements
  • Researchers released 16 apps, 5 during and 11 after it’s launch
  • ResearchStack introduced an Android version of ResearchKit
  • Many big pharma companies began exploring the use of ResearchKit

With these notable milestones more intriguing fact is how ResearchKit is changing clinical research.

Here we mention 5 big changes that ResearchKit is bringing to clinical research:

1. Easy Recruitment, Hard Retention

ResearchKit could help overcome one of the biggest challenges in recruitment of clinical research participants. You can’t deny that ResearchKit offers unique recruitment opportunity.

iPhone being ubiquitous enabled us to recruit in a way that would match a far more expensive, national clinical study done in the conventional manner.

But sometimes solving one problem creates another.

Now participant retention has become more of a challenge for ResearchKit apps. Like with any app, there’s fast adoption and decay in use. This decay has led to retention problems for apps like Share the Journey, which studies breast cancer treatment symptoms.

With the help of patient’s feedback and advocacy groups, it’s learned that in order to better engage and retain patients, the need to reduce complexity of language and tasks in the app is apparent.

2. Participatory Research

The conventional research model is not participatory. Many participants are now demanding more involvement. Even well-intentioned researchers can struggle with conventional research model more participatory.

Participatory research can aid with retention. People give more value on things they helped to create, a phenomenon known as the Ikea Effect. And when participants help to tailor the research, it becomes uniquely customized to their needs and what they value.

3. Convergence of Research and Care

Since information does not flow easily between research and care, opportunities are missed to create new knowledge.

ResearchKit can provide benefits similar to those provided by the Learning Health System. One of the great qualities of ResearchKit is that it centralizes the conduct of research. By centralizing research and care within an app, a seamless and rapid continuously learning loop can be created, similar to that visualized for the Learning Health System. Such a combination would be a win for medical advancement and all of the people who benefit from it.

4. A Learning Research System

Researchers don’t have a good option to improve how they caeey their research. Researchers can’t easily learn from each other, and popular innovation models have limited value in research.

ResearchKit can help researchers get pretty good at research.

Besides improving upon their methods, there can be diversification of researches, resulting in more customised research designs. A comparison for the first and second generation of ResearchKit apps, more diverse research methods are found in the second.

5. Multi-Dimensional Health Insights

Clinical researchers have access to limited data, which means limited view of health and disease. The types of data are often the most traditional ones, not necessarily the most useful ones. Moreover the collected data is only intermittent, like during a visit to the research site.

ResearchKit can collect new data at more regular intervals, offering a far better view of health and disease. One of the great success for ResearchKit is that multi-dimensional data will yield multi-dimensional health and disease insights.

If you are looking 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 need of efficient professionals , you should consider optimizing yourself with our institute of clinical research.

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

Related Postes:

Related Posts:

1) Clinical Research training in CRB Tech

2) Clinical research training course in CRB Tech

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4 Benefits Of Blended Learning In Clinical Research

4 Benefits Of Blended Learning In Clinical Research The work of Healthcare professionals is carried out in high-pressure and under very stressful environments, where they must be prepared on a regular basis for any and every situation, life-threatening or any. So it is not safe to say that it benefits everyone when these professionals have the most effective ways for training, and education. Clinicians’ knowledge and the clinical courses have to be up-to-date, and it needs to be delivered with efficiency. The teaching, the practice, and the enforcement of this knowledge and information is an integral part of the healthcare system, and the inclusion of these components helps it work as it does.

In this article we would look over which aspects of blended learning can benefit the way clinical research is delivered in health-care.

4 Benefits Of Blended Learning In Clinical Research

Online Learning

Clinicians can complete online modules that give them with a basic foundation of the topics they will be learning. These modules ensure that everyone is on the same level, based on the same background info prior to classroom or hands-on training. It also provides freedom to incorporate non-traditional learning materials. Another key attribute of online learning is the ability to learn from colleagues in the network. Works can be compared, and your reports with others within your facility, your department, your region, and/or your nation. This allows you to see how you rank amongst your colleagues, what you are excelling at, and where you might be falling behind.

Simulations

Simulation is the imitation of one act or system by another. A good example of this within a health-care setting is practicing patient care on a manikin. Simulations are great for with respect to personal development and goal setting. They allow clinicians to practice their skills in an environment that is same as the one they will be working later. The repetitive practice allows for the development of muscle memory, and specific problem solving skills that will be beneficial in real life situations. They help ensure that clinicians are well versed to react and respond quickly to life-threatening situations in a high-stress environment. As well, simulations are also a great way to facilitate team building and team training. The health care environment is not one that thrives on the work of individuals, but on a group of people. Effective communication is essential in the high-stress environment of health care facilities, and this requires a proper team based training.

Coaching and Mentoring

An important feature in any learning environment, is one-to-one training. Coaching is very essential to learning and growth because it provides support and guidance. Coaches inform candidates of what they are doing correct, what they need improvement on, and overall, encourages self-esteem so that candidates feel ease and confident in their skills. Coaches should be skilled and experienced in the topics they are teaching, so that they can draw from their own acquaintances to help clinicians with their challenges. In a learning environment whih is based on technology, there still needs to be a human component, and coaches play that role.

Classroom Learning

Classroom learning is the conventional learning method that, when combined with non-conventional learning methods, has great added value. Students now have the basic information they need i.e. online learning, they have the practical knowledge , and they have the support and guidance they need to achieve their learning goals. Classroom learning is the final piece of the process for a blended learning approach in health care. Students can share ideas , can interact to learn from one another, and they can come to conclusions together. It is really a community building aspect of learning that motivates health-care professionals and makes them bond over their common interests and goals. It creates a good environment for clinicians to work, grow, and thrive in.

In the race of many institutes and CROs, CRB Tech Solutions has created its own niche. Its very popular in offering the best Clinical Research Training programs.

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

Related Posts:

1) Clinical Research training in CRB Tech

2) Clinical research training course in CRB Tech

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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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What Is Clinical Research And It’s Scope in India?

What Is Clinical Research And It’s Scope in India? Clinical research is a current knowledge-intensive and booming industry. It is one of the industry growing at an astonishing rate and opening up a wide scope of employment opportunities for trained professionals.

It provides scientific analysis of the impact, risks and benefits of medicines or a medicinal product. The trials are done before initiating the products in the market. The tests are performed at different stages and after-launch supervision is maintained to scrutinize the safety and monitor the side effects if any. It is the best time to become part of this fast evolving industry. And an educational qualification in clinical research will help you suffice.

What-Is-Clinical-Research-And-Its-Scope-in-India

The term clinical trial refers to the entire record of any test article from its initiation in the lab to its introduction to the market and beyond. Once the promising molecule is identified in the lab, it is subjected to more per-clinical studies to get an idea about different aspects of the test article. Clinical research is often conducted at academic medical centers and recognized research centers.

Many believe that informed consent makes clinical research ethical. However, informed consent is not sufficient. Drawing on the basic philosophies there are some requirements that systematically explain a logical framework for evaluating the ethics of clinical research studies. The requirements are universal and they must be adapted to the various fields in which clinical research is conducted.

A Clinical Research Associate (CRA) is a health-care professional who performs activities related to clinical trials. They are the soul in the field of Clinical Research. The experts find their place in various organizations such as pharmaceutical companies, medical research institutes and government agencies. Depending on the organization’s policies different education and certification requirements may be necessary to practice as a Clinical Research Associate.

Clinical data management (CDM) is a critical phase in clinical research. CDM leads to generation of superior quality, dependable, and statistically well informed data from clinical trials. The ultimate goal of CDM is to assure a well maintained data support conclusions drawn from research and thus achieving this goal protects public health and creates confidence in the world of therapeutics.

Clinical Research Organisation (CRO)A CRO landscape is vast; using a CRO’s expertise you can maximize the efficiency of your clinical trials, but only if you choose the right one for the project at hand.

Typically, a CRO will organize and conduct clinical trials to check the test molecule in humans. As independent companies, they offer an objective assessment of a new drug in the clinical setting and since they partner with many companies, typically provide broader experience.

All CROs don’t make to the top 5 positions; but what differentiates them is the particular people they have on their team, the relationship you have with them and discussions about things like quality. Its tougher to say who’s the best CRO so a logical and intuitive decision is the key.

Clinical Research in India

India is evolving in many phases to run the race in the world; and Clinical Research is one such phase where India is making remarkable development and growth. India has been involved in clinical research for the past many years and is now on its way to becoming a major focus for it. The billion dollar industry is already witnessing high demand for qualified professionals. Indian pharmaceutical industry is one of the fastest growing sectors of the Indian economy and has made rapid strides over the years. There is a massive need for clinical research professionals in this fast-growing field. Clinical research makes an interesting career option with a great scope for professional growth. To build a career in clinical research, basic education in this field is necessary and a good hands on is the need. Check our Clinical Research training reviews for more training information.

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