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21 Trends for Nurse Practitioners in 2016 Part-I

21 Trends for Nurse Practitioners in 2016 Part I

Today we write this blog topic and shall continue discussing in our next upcoming blogs the same in details. In the booming story of healthcare sector the nurses have their own role and applause is credited to them.

The purpose of this blog piece is to explore 21 health care trends to watch for in 2016 that could impact nurse practitioners and help in healthcare reform and as a whole towards the health technology. Here I’m discussing a few and the rest will be discussed in our upcoming articles.

Nurse Practitioner Concerns

Changing Demographics

Conventionally the nursing profession was filled with middle-aged Caucasian females; now since the past decades, there are some demographic changes. Recent nurse graduates are more educated, with ethnic diversity and younger. Even more men are entering the profession than previous counts.

New graduates opt to choose non-clinical nursing careers in informatics, health policy, education and hospital administration. Younger nurses are more in a haste to change the profession.

Non-Nurse yet Nurse Practitioners

It is common that “non-nurse” are willing and rather practicing as nurses. Non-nurse nurse practitioners are those who work as a nurse without any previous experience as a nurse.

Physicians find these non-nurse nurse practitioners more clinically proficient than those with registered nursing experience.

Doctor of Nursing Practice

The growth of the Doctor of Nursing Practice (DNP) degree has increased everyone’s expectations.

The University of Kentucky College of Nursing began the first DNP program in 2001, which mainly targeted educating clinical executives. Today, DNP graduates are enacting a variety of roles which includes specialist clinician, primary care provider, research scientist, professor, advocate, informaticist, lobbyist, and executive.

Enhanced Autonomy

In the early part of 1980s, Oregon, Alaska, New Hampshire, and Washington were the first states to adopt more advanced legislation surrounding nurse practitioner rights

Though the physician community objected, the Institute of Medicine, Robert Wood Johnson Foundation, and Federal Trade Commission (among many others) supported legislation that permits nurse practitioners for independent practice. Independent practice has definitely reached a tipping point, with more and more state legislatures removing the outdated laws that prevent patients from receiving services from nurse practitioners.

Skytouching Salaries

The nurse practitioner salaries have increased over the decades even faster than inflation and they also surpassed their physician assistant colleagues.

Faculty Shortages

In March 2015, the AACN published an update on the scope of the nursing faculty shortage. This crisis continues to grow due to college budget constraints, an aging faculty, and job competition from clinical sites.

High Job Demand

Yet their job demand continues to rise. In 2015, the United States Bureau of Labor Statistics projected a 31% growth rate for the nurse practitioner profession compared with the average of 11% for all other careers. According to Fortune Magazine, nursing remained the most in-demand profession across the world this year, and nurse practitioner was ranked the second best job in America by U.S. News and World Report.

To be contd.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing 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.

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Myths and Reality Of EDCS In Clinical Data Management

Myths and Reality Of EDCS In Clinical Data Management

Today in this blog topic we would discuss EDCS and its utility in CDM i.e. Clinical Data Management. EDCS is the acronym for Electronic data capture System.

EDC is very common in usage in clinical study yet there are so many myths and misconceptions surrounding the move from conventional, paper-based clinical data input to EDC. The only fact is that EDC technology more the cloud-based systems are comparatively a recent addition to the clinical research industry.

Though EDC is no longer a novel object, yet it is too young to be embraced as the next industry standard. EDC is caught somewhere in between.

Here we discuss the myths surrounding with it and how to overcome them.

Myth 1: EDC is expensive

Reality: EDC cuts down study costs

Some EDCS are pricey to install, train the staff and implement, but the overall budget during the study and after the study cannot be underlined. Sponsor ROI for switching to EDC is well worth the initial investment.

The very thought that EDC is expensive is a remnant of the early history of EDC. When the technology was first initiated, as with any first generation thing, the more capable the system was the more expensive it was. EDC vendors are now available, all competing to overtake in performance the other guys and that too in the most attractive price point.

Myth 2: Switching to EDC involves too much time

Reality: EDC is very precious to study time

This myth has been true when EDC got first rolled out for clinical trials, but it is entirely a baseless argument today. To mention, 80% of the time and money spent on pharma development is spent on repetitively conducting clinical trials. For your information, EDC allows both for an attractive cost ROI and time ROI too.

On an average, EDC cuts 41% of pre-study preparation time.

Myth 3: Data stored in the cloud is unsafe

Reality: Cloud storage is comparatively more secure than on-site and/or paper

We all know and heard about the urban style of cyber theft. We hear horror stories of identity theft, hacking of bank accounts, etc. Always an exception exists for the rule; data storage for the most of of cloud systems is protected with huge and redundant security protocols against loss, theft or corruption of integrity. 

Myth 4: EDC is meant for massive Phase III+ studies

Reality: Studies of every size can take advantage of EDC

Though the origin or initiation of EDC was done keeping larger studies in mind like phase 3 clinical trials or later, but currently there are systems present to match every varying degree of study be it simple ones or complex. Of course, the longer the duration and greater the number of variables measured will explain the actual value of switching to EDC.

To mention EDC systems are very much customizable. If your next clinical venture is going to have more or less data than the previous study, your EDC vendor can work with you to customize the system as per requirement, so your team does not need to spend time and effort to source another vendor.

What are the possible disadvantages of EDC for CDM?

To be honest, there is not a single scenario where EDC does not defeat or is a better choice than paper-based data management in terms of savings of time and money. EDC is even “green” compared to conventional data capture methods.

We conclude.

Please let us know your opinion and views on EDC and its usage in CDM in the comment section below.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing 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.

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What To Do When An Outsourced Clinical Trial face A Crisis

What To Do When An Outsourced Clinical Trial face A Crisis

Today in this blog topic we would discuss outsourcing in clinical research and how to find a solution if an outsourced clinical trial hits a roadblock.

In the 1990s and 2000s, outsourcing already revolutionized the IT industry and experts have a belief that outsourcing has the power to revolutionize scientific research in the very same way. But under present situation, outsourcing in science is very difficult. It’s hard to find providers and is hard convincing them and also difficult to evaluate them and pay them. Well other industries solved these barriers by creating a marketplace, but the question is whether same solution is applicable to scientific researchers also?

Well Science Exchange can make makes outsourcing easy and wondering how many more discoveries can be made when scientists will be able to tap into the best resources. A very exciting thought!

But the fact is that keeping clinical trials on schedule is not an easy task. Whether a sponsor face issues with timeline, quality, personal or plenty of other things with an outsourced partner, it’s critical to address the problems as soon they arise. You are right we are making mention about the barriers that can be faced in clinical outsourcing.

When a clinical study hits a roadblock, there are a few options that can be addressed. One choice is to have a 3rd party interference, evaluate the situation, and oversee the original partner until study completes. Another option is that a 3rd party rescue where the study is taken over completely.

But while you take the decision about which option you should go for that would be best for your company, consider the following:

  • How fast does the database lock need to occur? If the DB Lock date has some good time remaining, it could be best to have a 3rd party come to the rescue. But, if only a couple of weeks are left, transferring the study is probably not a good idea; this might push away the timelines out even further and increase costs. In such situation, the best solution might be to let the study be where it is, but get a 3rd party come in and take the charge.
  • Who possess the database? If your database is with the organization which initially contracted to conduct the study then moving it to another company could pose a significant challenge, as that alone needs more time and money. But if your study is being carried out by a company provides study and rescue operation, handing the task to them is often the wisest decision.

It is quite obvious that a sponsor choose a partner seeing on the monetary aspect and if the partner fails to keep the words! Over the years, two key lessons surfaced about outsourcing: (1) Need to give extra attention to the data quality produced by the partner, and (2) never accept words that appears very true and too good.

So keep the above mentioned points in mind while selecting your outsource partners, and there will be better chances of avoiding barriers in your research study.

We conclude here. Hope you liked the discussion let us know your opinion in the comment section below.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in offering the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current requirement of the proficient candidates, you should consider enhancing 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.

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Seeking HIV Treatment Clues In The Neem Tree

Seeking HIV Treatment Clues In The Neem Tree

Neem tree or the village pharmacy is being currently being researched to seek remedy for Aids treatment. As a child we were always said about the medicinal values, now the world is trying to find out its special advantage in fighting the smart mutant virus called HIV.

Currently an assistant professor at Kean University in New Jersey, Arora is trying to understand the curative properties of the neem tree in fighting the deadly virus that causes AIDS. With her research work she presented the found data at a poster session on April 22, at the Experimental Biology 2012 meeting in San Diego. The initial results indicate about compounds in neem extracts which target a protein that helps HIV to replicate. If further research is being done with her findings, Arora’s work might give a novel drug to the world that is deliberately fighting with HIV-Aids.

As a Botany student I read about the neem extracts from leaves, bark and flowers which are used throughout the Indian subcontinent to fight against pathogenic microbes. It is also known to that the branches are used and not the duo toothpaste and toothbrushes to keep teeth and gums healthy, and neem extracts are popularly used to prevent the spread of malaria.

Even early practitioners mentioned in Ayurved books and scripts about the medicinal value of neem. It is actually regarded as a type of traditional Indian alternative medicine. There are treatments in which neem extracts are prescribed along with other herbs, to treat heart diseases and control diabetes. The neem tree, with scientific name Azadirachta indica belongs to the mahogany family, which also grows in eastern part of Africa.

Arora’s academic training gave her an expertise in the cellular biology of Oncology, Pharmacology, Bioinformatics and Physiological biology. In 2008 when she set her laboratory with a novel and innovative ideas and direction at Kean University, Arora was determined to combine her knowledge with her long-time penchant for natural products. The neem tree is one of her first choice.

Arora explored into the vast ocean of scientific literature to find what was already known about neem extracts. During that endeavour, she came across two reports that depicted that when HIV-AIDS patients in India and Nigeria were given neem extracts, the amount of HIV particles in their blood got reduced. Overwhelmed, Arora wanted to see if she could find out what component in the neem extract could be fighting off the virus.

She made use of her knowledge to bioinformatics and structural biology to see what she could find by making computer models of HIV proteins with compounds present in neem extracts. By reviewing literature, she and her pupils found 20 compounds present in various types of neem extracts. When they tried creating model for these compounds against the proteins crucial for the HIV life-cycle, Arora and her team discovered that most of the neem components attacked the HIV protease, a protein required for making new copies of the virus.

Arora’s team is now working on experiments with test-tube to find if the computer models are similar to actual samples. If her effort succeeds and her assumptions materialise out, Arora thinks that neem tree will give a cheaper and easier way to fight the HIV-AIDS rise in developing countries, where current therapies are too costly for the general or lesser mass.

We conclude here.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in offering the best training in Clinical Trials.

Clinical research jobs in Pune are increasing and to meet the current requirement of the proficient candidates, you should consider enhancing 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.

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How To Get The Right Patient In Making A Decision

How To Get The Right Patient In Making A Decision

With the rise of clinical trials all over the world, there is an increased involvement of patients in medical discussions, a very welcoming policy or methodology. They have rights, not only since they are the ultimate customers but they are every essential to the entire process. Their views can help in the regulatory process, with its raising sacle of interactions like patient representatives in some of its scientific assessment of individual products.

It is a two-way path, too. For every soul concerned in healthcare sector, an informed patient can help and support make care more effective, with improved support, more developed relations with respective physicians, and wider broader understanding of the challenges of drug designing and regulation.

But this two-way path can also prove to be dangerous. Patient’s opinions and demands might not always share the logic of the process that produces their products. It is quite reasonable to seek passenger’s views on the attribute of aircraft seats, but they have quite less to contribute on airframe design or navigation. In similar ways, not every view of every patient is could be helpful in determining the most appropriate scientific, clinical or commercial approach to medicines. An wrongly informed patient can make a doctor’s life pathetic.

So how can you strike the right balance into customer links and decision-making on remedies? A European project that began at the end of October is aiming to take over this hurdle. The final outcome would be suggestions to support developing guidelines for industry and health technology assessment authorities. In simple words when and how should decision makers give an ear to the patients?

The project, sponsored by EU’s joint-venture in drug research, would mainly concentrate on three disease areas where patient and clinical trial partners have expertise: neuromuscular disorders, rheumatoid arthritis and cancer.

According to Ulrik Kihlbom, one of the Swedish academics involved in the above mentioned project, the challenge is very real and needs a thorough discussion among a wide range of partners. How could a settlement authority weigh the patient perspective against cost-effectiveness when making a repayment of money decision, he reviews? Or how does a regulatory authority weigh patient need contrary to safety matters? Patient’s views need to represent the actual opinions patients have, and be unbiased. And for the individual customer, at what point should his or her voice be listened to? When his or her first diagnosis occurred, or when was under treatment? It is recommended that the patient’s choice will definitely change during the occurrence of illness. Is it to know when your choice is such that your physician must listen to them?

At this present time in Europe, patients’ voices are being increasingly given attention on concerns as wide as access to social and health care, availability of medicines, assessment of health technology and the shaping of broad health policy, the preferable initiative is quite in time. The very question, however, is whether Europe can wait for more years for its recommendations, as “patient potential” is already coming up very strongly, whether it is “correct” or wrong.

In the competition of many other organizations, CRB Tech Solutions earned a good name. It has earned a niche in providing the best training in Clinical Research.

With increasing Clinical research   there is an immense need to meet the current requirement of the efficient candidates, you must consider improving yourself with our clinical research training program.

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

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How Clinical Research Certifications Help Pharma

How Clinical Research Certifications Help Pharma

A non-profit organization, National Board of Medical Examiners (NBME) has been around for about 100 years. Its primary mission is to assess the qualifications of healthcare professionals. Though it’s popularly associated with the U.S. Medical Licensing Exam (USMLE), NBME also has also impacted different healthcare professions, which includes medical assistants, veterinarians and physical therapists. Very recently, the group has been looking into designing an assessment that would be beneficial to clinical researchers.

The researchers conducted by NBME, has a goal to determine their main points and evaluate if there was a need for some type of standardization, especially in the area of training. They assessed there was a need for training, a method to calculate the effectiveness of it, and to lessen redundancy in training that existed.

By the conclusion of their research, NBME developed two certification programs in association with clinical research experts. One for clinical investigators and scientists, while the other is for monitors, associates, and coordinators. The mode of assessments include basic knowledge in clinical research, which includes ethics, study design, manage data and other topics professionals would need to be aware of, irrespective of their role in the clinical trial process. The two certifications vary with respect to specifics of the positions.

In order to apply for the exam and gain certification, the examinees must give their eligibility evidence, including education and experience in clinical research. The multiple answer exam takes 4 hours and 15 minutes to complete.  After the exam, examinees can review information about their performance, including areas of strength and weakness. If an organization makes the exam available to their employees, that organization can receive aggregated information on staff performance so as to identify knowledge areas in need of improvement and improve future training for researchers.

For the CROs and for sites, having this certification in place for researchers ensures staff proficiency and knowledge to current and future partners.AS mentioned, the certification is individual specific hence not portable. Once someone is certified, that certification will enable them wider opportunities. For sponsor companies, the certification ensures that their internal trials are being handled by qualified professionals.

During the start of research they found there were other programs available to clinical researchers which were webinar-based that would grant participants a certificate after completion. Their mission is to create a program that would be effective at determining a researcher’s skill set.

Though there are other clinical certifications available, like SOCRA and ACRP, and have their own certification programs, but they are quite specific to defined titles within the industry.

To conclude, Short notes NBME became aware of the requirement for certifications after the organization of physicians working in clinical trials wanted to ensure proper certification. Upon evaluating those concerns, NBME realized the need for a pathway for individuals to get into research, which involved improving those skills that they need to be successful.

Hope this certification program will delete some of those challenges and make the certification process easier for professional who want to pursue in this field.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in offering the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current requirement of the proficient candidates, you should consider enhancing 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.

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Drug And Medical Device Clinical Trials

Drug And Medical Device Clinical Trials

To understand the similarities and appreciating the differences is essential. A well-planned and controlled clinical research can save both time and wealth. To mention, the faster and more accurately a trial is done, the faster the test article can be place in the market and begin helping the human species. In this blog topic we get together the similarities and the differences too.

Clinical trials are basic to the development of novel, investigational objects such as drugs or high-risk (and a few medium-risk) medical devices. Many products are found to be or appear safe and effective during in vitro testing or animal studies, but they can’t confer the same effect in humans. These novel products must be proven safe and effective in a clinical study in humans before use in the mass population.

Clinical trials for Drug development

Drug development is quite complex, consumes whole lot of time and resource-specific. It requires thorough attention to ensure how appropriate it is for the drug or biologic.

Clinical trials for Medical devices

For medical equipment, often there are changes in the design and use is quite common and often do not need prior approvals of regulation. In vitro and/or animal testing are often enough to assess the suitability of a design change

Differences

Drug Device
Primary Administrator Patient or Patient’s Caregiver Investigator
Principal Investigator Supervision Required? N Y
Patient Responsibility High Low
Physician Involvement Low High
Training Process Observational

Staff and patients are informed of administration process, expected side effects and adverse reactions.

In practice

Complex equipments might need extensive investigator training, including cadaver labs, animal models, or proctoring during life cases.

Cost of Product Usually given free of charge High cost with subsequent reimbursement


Similarities

Both needs adherence to the following regulations:

  • 21 CFR 11 – Electronic medical data
  • 21 CFR 50 – Human subject protection
  • 21 CFR 54 – Financial disclosure
  • 21 CFR 56 – Institutional Review Board (IRB) requirements

On the other, drug trials must abide by 21 CFR 312 (investigational new drug application) but device trials don’t need to abide. Whereas, device clinical trials must abide by 21 CFR 812 and drug trials do not.

To mention, these two regulations have a number of similarities, a few are mentioned below:

  1. The exact submission must be done to the FDA before starting an investigation
  2. Amendments are needed when changes are done
  3. Annual updates on study progress are essential
  4. Both sponsor and investigator responsibilities are well defined
  5. Investigation must be done in accordance with the investigational plan, signed agreement, regulations and conditions of approval imposed by the IRB
  6. Investigation must be properly kept a watch.
  7. IRB approval must be done prior to beginning of the investigation
  8. Labeling what is required are specified
  9. Significant information must be given to subjects
  10. Sponsors must give information to investigators

Drug and device clinical trials have several similarities and differences, but the final count is the goal and that is the same: introduce safe and effective products to the public as quickly as possible.

We conclude here. Hope you will like the compilation; it’s informative and quite simple and short. We gathered these from various web sources.

WE conclude here.

In the competition of many organizations CRB Tech Solutions earned a good name. It has developed a name in offering the best training in Clinical Research.

Clinical research jobs in Pune are getting increased and to meet the current requirement of the proficient candidates in the field of clinical trials, you should consider enhancing 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.

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What Does Patients Want from Pharma

What Does Patients Want from Pharma

Time is changing! So also different approaches and methodologies. It’s now time to listen to the patient. And look at the nose. These words were uttered many years ago during a workshop on allergic rhinitis . These deceptively simple words were spoken by Dr Bill Frankland, one of the most distinguished clinicians of the 20th century.

He emphasized on putting the patient experience first. He was of the opinion that listening to the patient was critical to understanding what interventions might be required.

His interest in treating patients like grown-ups was way ahead of its time. Even now, when the patient is speaking, the doctor may not always be listening. The opinion of the patients get filtered.

This is not just a failing of the medical profession. Though the healthcare advocates talk about patient-centricity all the time, but in practice that often remains on paper only.

Now what do you mean by patient perspective? The following is a definitive though not obvious list of patient needs, but it might provide a useful framework for discussion.

1. People and not patients

We don’t want our lives to be defined by illness. We are living beings and not passive objects. We need to live as people and not like patients.

2. High expectations

We desire importantly, even in the face of chronic or acute illness. This says the importance of mental health for a physical health, and vice versa.

3. Holistic wellness

Breaking down the barriers between the providers of education, nutrition, health, exercise, transport and social care and creating a genuinely holistic approach will need a revolution in thinking, but it is the only way to put the person at the center. The role of pharma here will be critical .

4. Rapid diagnosis

This means that the doctor will work out quickly what is wrong with us yet, sadly, and especially in rare diseases, this might not happen. For example, with Fabry disease, a leading UK expert said it can take 10 years and 10 specialists before a diagnosis is made in a child not previously identified as being in a genetically susceptible family. We need a better understanding of the costs of such delays in diagnosis in terms of wasted medical resources,family disruption, time spent and loss of childhood. For the affected individuals these costs are almost incalculable.

5. Sharing the experience

These personal costs depict the need for, and importance of, groups for patients to share their knowledge, provide each other support, speak in a strong voice and be powerful research partners. Even with more common diseases, there is a huge gap between proven best practice and what happens in the field. For instance, it took many years for ACE inhibitors to make way into everyday practice in the management of chronic heart failure and, even today, we struggle to sustain the condition in the face of really clear outcome evidence, leaving patients incapacitated, in the hospital and unable to perform simple acts of daily life.

6. Education

More education is needed at every level, and pharma sector has a big role to play in listening to and informing both physicians and those they treat. Let this knowledge be both evidence-based and respectful.

We conclude here.

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

Clinical research jobs in Pune are increasing and to meet the increasing need of the proficient candidates , you should consider enhancing yourself with our clinical research program.

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

Related Topics:

1) What is the Career in Clinical Psychology?

2) Know how healthcare education online can transform your career

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Being Human to NGOs and Inhuman to Drug Research

Being Human to NGOs and Inhuman to Drug Research

The clinical research sector since the year 2005 has been expected to grow in double digits due of its vast patient population. But a key question on being human or inhuman with investors, analysts and all stakeholders who have been observing this market in the recent times.

But things have not been good for the industry particularly since 2010.

The data available at the Clinical trial registry of India has been witnessing a step hike in the registrations since it came into inception.

Owing to some unavoidable circumstances, defects in clinical research practices came to light in a hospital based trial in a metro city in India in 2011. This happened despite the fact that the trial was registered at all major sites and was being done by a popular pharma company. The matter came into notice when an NGO filed a petition in the Supreme Court in protest against possible anomalies in their practices. Seeing the same, the Supreme court issued an order to the Indian drug regulator to outline strict laws to conduct clinical researches in India increasing concerns with respect to Ethics and Ethics Committees, safety of volunteers, informed consent matters and volunteer compensation in case of adverse events. Based on the same, a committee was formed to present before the parliament its advice. The words of the committee were brought to the notice of the regulators and the industry leaders for their further action and comments.

Anyways the Supreme Court placed an order on the 30 September 2013 that no clinical trials can be approved till the laws are followed.

This news was published in major newspapers in India. In the current scenario, the Indian regulator cannot approve clinical trials even if the same are in view of public interest. This decision that came from the Supreme Court is expected to expedite the rule formation process. However it is difficult to say in the present times as what will be the impact of the Supreme Court order. According to the key industry leaders, an impact as a consequence would be that it is likely to take away the clinical research practice away from India.

In the name of ethics, a lot of suffering is about to fall on the world of novel drug research. Novel drug research is heavily dependent on outsourced clinical research and people will continue to suffer and die of incurable diseases. Some believes that humanity will be at stake if the law makers continue to support “only humanity”. Little do they realize that the future of humanity is at stake as “unknown” disease continue to lurk the human population.

Clinical study reports explain every aspect of the clinical trial for a novel drug, including the number of participants, methods, analysis, and conclusions. Releasing this data is a huge step in the very competitive and too secretive pharma industry, it is researchers, health care providers, and patients who stand to gain.

Either way, these test subjects came volunteering for these programs, freedom over own body etc. True, there is a chance that test subjects stand to see their health improve. But when people register to participate in drug trials, they are signing up for a casual game of Russian roulette with their health; the stakes are high.

Hope you liked this perspective on clinical research.

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

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

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

Related Topics:

1) How Does Clinical Data Matter?

2) What Mobile Should Mean For Health Care Part 1

 

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How Does Clinical Data Matter?

How Does Clinical Data Matter?

Every year, worldwide, many new companies enter clinical research sector. Academic scientists, capitalists, refugees from big pharma all of them revitalize and entertain the scientific industry.

But the awareness of best practices isn’t always evenly distributed. Certain domains of knowledge seem to be more detailed represented in young companies. That’s a concern at Quanticate, a CRO that specializes in data management and biostatistics.

In words of CEO and chairman David Underwood, a lot of them are virtual companies with venture capital backing, and have clinical backgrounds. Hence they fail to grasp the importance of the biostatistical design and analysis.

Rescue Situation

In a startup, every dollar, every euro is precious. So often they practice allocation of limited but important resources.

Underwood said he has seen businesses find shortcuts. He said that some vital companies didn’t designed the trial properly or analyzed it thoroughly, eventually let out good drugs since they didn’t maintain any data.

Role of CSP or centralized service provider

In words of Underwood’s, a CSP is a trusted, specialized, go-to company where a sponsor designates a particular task or type of work must be always centralized. He also reported that some unknowable but quite a significant fraction of work in the clinical research is duplicated.

In some cases, Underwood said that , mid- and small-sized sponsor firms are looking at the epic CRO-sponsor deals being done by mega-CROs and sponsors. They want a different model, like the data doesn’t seem to fit in these types of relationships.

Client Templates

A United Kingdom based Quanticate has 200 people on its staff. Underwood said that they focused on data. They have a higher proportion of experienced statisticians and they try to combine the biometric functions into a central provision.

The ultimate goal is to simplify those unruly diagrams of which firms do what across all research trials. Underwood said that if they can standardize database design, then they can use the same programs again and again. He said that they’ll be using the template they set up for others. They will be get a saving. He continued to state that they work across the data across all their functions, be it biostatistics, medical writing or data management.

He believes that the savings in time and money would be serious, if all those things come under a same roof, theoretically the final point can be attained much sooner.

Mystery R&D

To mention that in a few cases, some CROs have been a bit touchy on the question of how, whether and when clients can peek at clinical data. Some CROs have addressed this and a many didn’t.

Underwood is trying to take the concern off the table. He provides customers access to an internet portal. With the right user privileges, a user should be to see any appropriate, available aspect of the project. Underwood realizes that some sponsors might want to push a button and export their data to another CRO with a different set of duties. He’s fine with that practice. He said they doesn’t want to lock the companies in.

While discussing future plans, Underwood hints of an R&D initiative within Quanticate that might matter the typical budget of standard clinical trials, especially antiquated processes that are virtually sacred in some quarters of the research industry. They won’t be sending thousands of clinical research associates all over the place. A change is required, so this practice need to be stopped was quoted by Underwood.

We conclude here.

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