Clinical Research Courses

The Need Of Clinical Research Courses In The Curriculum Of Medical Science

Clinical Research is an upcoming field of education in the medical science. The latest opportunities in this profession are likely to appear in the department of clinical research. This is due to the leading Clinical Research Institutes which are introducing Clinical research courses in their academic curriculum. This blog is meant to assess the different aspects and features of the clinical research department.

Clinical Research Courses

Clinical Research Institutes

Assessment of the pros and cons of clinical research institutions

There are several Clinical Research Institutes which are providing different types of courses in the clinical research field of education and learning. These courses are taken up by the doctors or the aspiring doctors. The different courses offered to follow either full time or part time, pattern. Clinical research courses are also offered as an elective subject by the institutes.

It is seen that doctors often choose the part-time course at Clinical Research Institutes. This helps them manage a balance between their practice and their coursework parallel. This course further helps in enhancing their skills in the field of clinical trials. Thus, it is essential and beneficial for the medical students to pursue this type of course for better knowledge and also future aspects.

Scope of clinical research courses

The scope is endless! The Clinical Research Courses are provided on an endless scope to continue with in future. The students attain a professional experience of clinical and training after they register and complete the specific course. The leading Clinical Research Institutes provide great placement offers after completion of coursework. There are many pharma companies who have linked themselves with these institutions. They offer great salary packages to the deserving students. It is indeed a responsible and a lucrative career.

It is understood that the students who earn a degree in a course related to clinical research often have an upper hand and beneficial offers in the future.

We conclude now.There is a consistent rise of clinical research jobs in Pune. If you are looking for Clinical Research courses in Pune, then you must consider the clinical research training program offered by CRB Tech Solutions.

And stay connected with this space for more discussions on Clinical Research and Clinical Trials.

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clinical research career

Clinical Research Career And Job Opportunities In India

Clinical trials are significant to market all novel drugs and devices to ensure that they are effective and safe for use. This scenario is creating several job opportunities in this fast-growing industry. Besides strict regulatory measures, India is growing as a center for clinical research which creates a constant demand for professionals in this area. Presently and in future as well, there will be high demand for professionals in this sector and hence making clinical research career an emerging choice which promises huge growth.

clinical research career

It is undeniably true that the clinical research industry is going to become the next big career option in India. Owing to India’s huge population, significant workforce and the cost-benefits have started to impact the major Pharma and CROs to arrange clinical research facilities in India.

With the rise of demands for efficient clinical research professionals, several institutes have started their clinical research training courses and programs.

One of the best names is CRB Tech Solutions, Pune who help with proper guidance and support as you do your course and also helps in finding a good job.

With its 100% placement guarantee, CRB Tech is the finest choice among students for clinical research training program in Pune.

And with its well-structured curriculum and its updated syllabus in accordance with industry standards, CRB Tech Solutions is one of the best training institutes in Pune.

Here we look into various clinical research career options:

Clinical Research Associate (CRA)

With a bachelor or master degree in life science or any related field and with some clinical research experiences, you can apply for a clinical research associate position.

CRAs mainly monitor clinical research sites and make sure that all activities are taking place in accordance with the GCP and sponsor guidelines. Based on their performance and company policies, CRA might be promoted to a senior CRA and later to become a team lead and next to a manager.

Clinical Research Coordinators (CRCs)

This is an entry-level job where the professionals work with or within the supervision of a Principal Investigator (PI) of the clinical research.

Roles and responsibilities of CRCs

  • They coordinate with Principal Investigators (PI), and other CR departments to help and ensure that every clinical research activities are conducted in accordance with regulatory authorities and sponsor policies.

  • Aids the PI in material development and of the resources essential to train professionals engaged in a clinical trial.

  • They maintain records related to the registered clinical trial participants and completion of essential site documents.

To become a clinical research coordinator one must have a bachelor’s degree in life sciences and have good knowledge about clinical research methods and the GCP-Guidelines.

Clinical Research Physician

Those who completed MBBS or MD are eligible to become clinical trial physicians. They need to develop and apply different plans for beginning the clinical trials of pharma products. They have to work with several professional teams on various aspects like pharma effect, regulatory specifications etc. of the test drug under study.

Regulatory Affairs Associate

With a good understanding of different regulatory authorities and their needs to do clinical trials and with an interest to work on core clinical trial operational processes this is the perfect job for you. They need to yield documents needed for performing clinical research to regulatory authorities and also are in a regular touch with the regulatory agencies to get a feedback and also resolve queries if there is any.

Biostatician

To apply for this position, one must have a bachelor or masters degree in biostatistics. Here we share some of the major job responsibilities as a biostatistician in the clinical research sector.

1) Give statistical input on clinical trials

2) Develop statistical analysis plans for clinical trials

3) Develop tables and other charts for data representation.

4) Interpret a final clinical research data

5) Prepare statistical reports on the clinical trial

Clinical Data Management

With an interest in data management and also for a complete desktop job, this will suit you. The professionals have to manage quality and reliable data from clinical studies.

Medical Science Liaison

Professionals here have to communicate with physicians and researcher for enhancing the acceptance along with appropriate usage of the company drugs or devices.

Hence from the above, it is clear, how clinical research industry has several wide options and career choices which will gradually generate more and more job opportunities.

We conclude now.

Are you looking for Clinical Research courses in Pune? Then you should consider the clinical research training program offered by CRB Tech Solutions. And stay connected with this space for more discussions on Clinical Research and Clinical Trials.

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Get Yourself Enrolled For Top Clinical Research Associate Training In Pune

Those who are interested in making a career in healthcare science and pharma science often go for online clinical research training training in India. This could be because the present clinical research courses with government colleges and other institutes have outdated syllabus. In the last two decades, the importance of preclinical studies and pharmacovigilance has proven results to bring life-saving drugs, medical equipment and treatment methods by several pharma companies. This improvement happened due to the application of the innovative technologies and there are many private research institutes who conduct advanced courses of clinical research (CR) with management studies. They do have a clinical research associate or CRA degree program, which is a professional or job oriented course in India and abroad.

Clinical-Research-Associate-Training-In-Pune

The Need for CRA Professionals in India

There are so many pharma majors investing in India for the presence of a workforce and they can use them in CR related projects in their own pharma company. The pharma companies often look for graduates in clinical research from top institutes in India. There are several CRA job vacancies available with multi-national pharma companies, Indian based pharma companies, listed pharma companies and with academic institutes for jobs in teaching.

Salary of a CRA in India

Any CRA graduate certified from a reputed online clinical research program in India can fetch entry-level jobs of five-digit salary. However, there is a healthcare science and pharma science professional who are doing online clinical research courses and applying for senior positions in global companies. The salary for senior positions, position in management and technical position are more than any software professional’s salary.

Clinical Research Training Institutes in India

With the rise of clinical trials in India, many universities started offering clinical research courses in India. Many of them, they offer distance education program for CR and not any online training and certification in clinical research. To mention, there are a few reputed private institutes, who also offer CR courses as full time or with regular classes, part-time CR course, and online CR courses. They have a good and updated syllabus than what government institutes offer their students. In this context, there is a mention about CRB Tech Solutions, Pune who have created a good reputation for offering fast-track program in CR for the existing working professionals and graduates who intend to pursue their career in the healthcare industries.

With its 100% placement assurance, Clinical Research Training Program of CRB Tech is the finest choice among the students.

The CR Training program by CRB Tech Solutions offers guidance to key skill sets and knowledge in clinical research with innovative methods. The clinical research program is a 4-month certificate program which comprises of lectures, live projects, internships and soft skill development. The training program includes a detailed clinical research associate training for your advantage.

The modules of our Clinical Research Training Program are upgraded and redesigned periodically by our industry expert. There are regular campus drives as well for the benefit of the students.

We conclude now.

Are you looking for Clinical Research Associate jobs for freshers in Pune? Then you should consider the clinical research training program offered by CRB Tech Solutions for proper guidance and support as you do your course and also in finding a good job. You can check our website to enroll for the Clinical Research program. And stay connected with this space for more discussions on Clinical Research and Clinical Trials.

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Methods By Which Clinical Research Improves Healthcare Results

The ultimate outcome of overall survival or a better quality of life is the end results of a clinical research which includes a complex interaction between the patient, treatment and the healthcare unit.

clinical research

Defining and measuring the benefits of clinical research is the core purpose of any healthcare system for supporting a research infrastructure and this is very challenging. Healthcare professionals, makers of policies and the public recognize that clinical trials and studies are significant, and are broadly supportive, about the same.

Some mechanisms via which outcomes can be improved in clinical research settings:

Improvements in infrastructure

Infrastructure means the attributes of the setting in which the care is given to the accommodation, equipment and personnel. To run a clinical research needs physical infrastructure like space and specialized devices and services to perform research-based activities. While the infrastructure is used for research-related activities, it is to mention that once the research is over, the infrastructure remains.

Participation in clinical trials might get you to an early access to new technologies like novel surgical techniques or medications, which might be applied to non-research participants earlier than in institutions which didn’t participate in the research.

The other things about infrastructure are human capital. Doctors, nurses and other related health professionals who practice in research environments might be systematically different than their peers in non-research settings and might deliver better care.

Processes of care

The methods of care towards the patient can have a real impact on the outcomes and it is possible that such methods differ a lot between research-related and non-research related settings or practitioners.

Other benefits of research activity

The value of negative research is often overlooked, but some are quite important in terms of the costs, resource utilization, and side effects which are commonly associated with new, more technological or more complex interventions.

Moreover, the execution of clinical research programmes in an institution, region or nation is thought to be helpful in keeping excellent and gifted clinical experts and scientists, who might otherwise move in other fields or sectors.

The evaluation approaches

Knowing the connection between clinical research and its impacts is quite nascent and hence is a rich field for novel assessment approaches. An essential thing is that we must not be making assumptions about real representations. Opinion-based making of policies is the dominant culture and that holds evidence about a positive relationship between research activity and better outcomes.

Cancer research provides a rich area for studying the need of changes associated with infrastructures like surgery-imaging-pathology; medicines; radiotherapy and organizational aspects like the multi-disciplinary care.

Assessment the link between care and research is complicated. But several quantitative and qualitative approaches like cultural transmission, scientometrics, and tools of social systems exist but need ‘translating’ into the study of cancer research and patient outcomes. Cultural transmission theory could also be used to assess how research and healthcare professionals forward the knowledge laterally and horizontally and how this can change clinical management.

In short, how complex systems keep their integrity appears dependent on their capacity to co-adapt through good feedback loops. As a system, the relationship between cancer research and patient outcomes is neither linear nor necessarily positive.

Impact of patient characteristics

Patient and disease characteristics impact strongly on outcomes and it is possible that there are systematic differences as well. Social determinants of health like education and income are related to results in many areas of medicine. Often, patients with poor or lesser education, have worse outcomes: they might at a later stage, have worse health or have less reach out to care or simply do not navigate the system well. To mention, to make adjustments for case-mix, which includes both medical and social characteristics, will be essential in any studies that assess differences in outcomes of care between institutions in connection to research activities.

Summary

It is significant to measure the benefits related to clinical research but little empiric work has been yet done in this area. With mention about the costs of research, additional studies to realize the impact of research on health care results are essential and offer an opportunity for the use of innovative evaluation methods.

With this, we conclude.

Are you looking for Pharmacovigilance training in Pune?

To be successful in this competitive world you need cutting-edge technical training. Among the best training institute in Pune, CRB Tech Solutions created a good name for itself. We offer one of the best programs on clinical research training in Pune. The course in clinical research offered by us is industry oriented and scientifically programmed.

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Obstacles And Opportunities For Data Sharing In Clinical Research

One of the main agenda of sponsors, institutions, and publishers is open data and making data accessible and reusable. At PLOS they are of the opinion that more openness in data availability offers huge advantages to science and also happens to be a topic of discussion by all the stakeholders.

data sharing in clinical research

Request for PLOS ONE Data which was published related to the PACE trial

In considerations of patient privacy with respect to sharing of non-identified patient-level data in several papers that were published since strengthening the data policy, they encountered challenging cases.

In 2012 they published their entire data policy, the PLOS ONE article and stated that, adaptive pacing, graded exercise, cognitive behaviour therapy, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis, reported a cost-effectiveness analysis on results from the PACE (Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation) trial, originally published in The Lancet in 2011.

The PLOS policy reads as follows:

‘Publication depends on the writer’s accord to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research.’

They received a request for a hidden data in the article from a reader who indicated to us that he had previously contacted the authors but the dataset had not been provided, either by them or their institution. Other readers have raised concerns on aspects of the cost analyses – open exchanges about methodology and assumptions for the analyses had taken place via comments on the article soon after publication.

The PLOS policy in PLOS ONE states:

‘Publication is conditional upon the agreement of the authors to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research.’

They got a request for a hidden data is the article from a reader who said that he had earlier contacted the authors but the dataset was never provided, either by them or their institution. Other readers addressed the concerns about aspects of cost analyses, open exchanges about methodologies and assumptions for the analyses which took place through comments on the article soon after publication.

Assessment of data requests and follow up

The aims of initial steps in follow were: To find if concerns about analyses were prevented and, within the framework of editorial policy, demonstrate what data would be necessary to duplicate the work. They took advice from two editorial board members who suggested pursuing an access to the dataset and advised that individual-level patient were necessary to allow reproduction of the analyses.

Next, they approached the authors to request data and further information about their analyses. The authors were of opinion that releasing individual-level patient data exhibits a risk towards confidentiality of patients and releasing data would go beyond the conditions of the consent signed by the participants before the trial started. The authors suggested having the data evaluated by a commonly agreed mediator; but owing to the concerns raised by several readers and the requests for the data, they believe that this proposal would come short of the expectations of the policy initially.

They took concerns over confidentiality of patient seriously and hence approached Queen Mary University of London (QMUL), to request their support in setting up a mechanism independent of the authors to allow other researchers’ data access while preserving patient privacy.

Expression of Concern

PLOS understands that there is a framework to consider requests for data from the PACE trial. This framework demands direct involvement by the authors on considerations if the data can be shared, and puts other restrictions.

Current obstacles and opportunities

There is somewhat consensus of opinion regarding sharing of this particular dataset. Experts from Data Advisory Board expressed different views on the stringency of the journal reaction.

Advisory Board of PLOS noted the need for experts in trials to consider amendments to consent procedures on the incidents of data being shared. This is also mentioned in ICMJE’s proposal for sharing of clinical trial data, which proposes the authors of clinical trials share de-identified individual-patient data not later than 6 months after publication. The proposal was received by huge responses and mixed critiques, with some supporting while others rising concerned over risks of de-identification or inappropriate re-assessment unless enough information was given to the datasets.

Towards openness in clinical research data

The debate should continue. PLOS suggests they have seen benefits from setting clearer expectations for data sharing at the time of publication through their updated policies.

They know about the challenges involved and the fact that new problems will arise as policies for open data and new technologies are initiated but there is no point of settling on the fact that data cannot be shared. It is essential to put new efforts to overcome the obstacles towards appropriate channels for sharing of data from clinical research. It might take some time and would be quite complex but an open debate on the above matters is a huge step towards a framework that permits more openness in a clinical data.

This appears as a benefit not only to the field of science but also to the society as a whole.

With this, we conclude.

Are you looking for clinical training jobs, in Pune?

To be successful in this competitive world you need cutting-edge technical training. Among the best training institute in Pune, CRB Tech Solutions created a good name for itself. We offer one of the best programs in clinical research associate training and placement. The course in clinical research offered by us is industry oriented and scientifically programmed.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field

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Clinical Trials Phases In Cancer Treatment

A clinical trial is significant but also a very crucial part of a research. Before beginning a clinical trial, doctors must prove that there is a chance by which the new treatment or a method will work better than any presently available one. Research continues until it gets proved. Doctors do several clinical trials to test many things, which include:

Phases-Of-Clinical-Trials

  • A novel treatment or a medical process

  • An innovative mix of the existing treatments

  • A novel surgery

  • Novel medical device

  • Changes in lifestyle, like eating habits, exercise, or counselling

They might test the same on laboratory animals before testing it on a human. This is to ensure that it is safe to test on men.

Phases of clinical trials:

Each trial follows certain steps, known as phases. The steps are created to keep the life of people safe in the clinical trial. Sometimes, phases are done together, paralleled. To ensure that all the steps are done to help protect patients and give accurate results about what the trial is testing.

A volunteer can join any phase of a clinical trial if the option is appropriate for you and the type and stage of cancer you have.

Phase I clinical trials

The physicians do this to learn if a new drug, or a treatment, or a combination of treatments is safe for people.

In a phase I trial, doctors collect information on the following:

  • Dose or treatment

  • The count of taking the medicine or treatment

  • Any side effects or hazards

  • How a person responds to the treatment.

If you volunteer for a phase I clinical trial, you could be one of the first people to get the promising new drug or treatment.

The duration of Phase I clinical trials could be several months to a year. Often it constitutes 10 to 30 volunteers. The treatment might help the patient, and the trial information could help other patients in future.

Phase II clinical trials

This tells the doctors more about how safe the treatment or medicine is and how well it works. In phase II trials, doctors also test whether a new treatment really works for specific cancer. They might measure a tumour or take blood samples to assess if the treatment is acting. They can also ask you to maintain a log of your daily activities and symptoms.

A Phase II trial lasts for about 2 years. Sometimes, volunteers opt for different treatments. For instance, a phase II clinical trial can have 2 groups:

Group 1 – People who take the regular treatment (standard treatment)

Group 2 – People who take the regular treatment and a new treatment on which doctors are that studying in the trial

In another instance, a phase II trial can have 3 groups. Volunteers in each group receive a different dose of the new treatment on which study is being carried out.

If a phase II trial shows the treatment is likely to work and is as safe as a regular treatment, doctors can go for a 3rd trial phase.

Phase III clinical trials

This tests a new treatment that has worked well on patients in the 2nd trial phase. Doctors compare the treatment with the standard one. Standard treatment is yet the best-known treatment. The research team must find out if the novel treatment is better. Hence they need to assign people to various groups as a part of the trial.

Randomization

This means to assign people in a clinical trial into various groups. Doctors do this with the help of computer programs. This is important when doctors have to compare 2 or more treatments.

Phase III clinical trials continue for many years. They usually have several thousand volunteers. The volunteers must include men, women, and people of every ages, race and ethnic groups. This helps doctors with insight how a treatment works for several different people.

If a phase III trial shows that the treatment works well for specific cancer, doctors start to use it with people outside the trial. When it is learned that a new medicine is safe and effective, then is needed approval from the regulatory bodies. In the US, it is the Food and Drug Administration or FDA. The FDA looks over the results of clinical trials. If the information meets their standards, the treatment gets approval.

How is a clinical trial “phase” different from cancer “stage”?

The cancer stages are different from clinical trial phases, even though both uses same numbers of 0, 1, 2, 3, and 4. A clinical trial phase not necessarily meets the stage of cancer. You can be any stage of cancer and be in any phase of a trial. The “phase” of a clinical trial is to describe the purpose of the clinical trial and how many people taking part in it. The “stage” of a person’s cancer tells the following:

How much cancer has spread?

What type of cancerous cells is affected? Some types of cells indicate the cancer is more aggressive or can get worse, and some do not.

Does the patient need to be in every phase of a clinical trial?

Well, the answer is No. You can be part of any phase of a clinical trial. For instance, you might join a phase II clinical trial of a specific treatment even if you didn’t take part in phase I of the trial.

With this, we conclude.

Are you looking for clinical research training in Pune?

To be successful in this competitive world you need cutting-edge technical training. Among the best training institute in Pune, CRB Tech Solutions created a good name for itself. We offer one of the best clinical research courses in Pune. The course offered by us is industry oriented and scientifically programmed.

If you want to enrol in one of the best clinical research courses in Pune, then CRB Tech Solutions would be your right success partner.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field

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Why Scenario Of Clinical Research In India is All Set To Grow IN 2017-2018

Indian pharma industry has witnessed several achievements in the year 2016. The market got an impressive compounded annual growth over the period. By 2020, the Indian pharma market is expected to rank among the global top three by increasing growth and is supposed to be the 6th largest market in the world with respect to absolute size.

Clinical-Research-in-India

It is expected that India will be among the top 25 nations in the Global Innovation Index within the coming 10 years.

After a slow down experienced in the year 2013, the industry in India is seeing a steep rise. There are several reasons owing to this positive growth in clinical phases, 1 and 2 trials in India, the least being a proactive approach and business-friendly ‘Make in India’ initiative by the Indian government. 107 clinical trial NOC approvals were given in 2013 and this number leaped to 150 in 2014. And the rebound continues.

Here we discuss a few reasons why you can expect to see huge growth in the Indian clinical research sector in the coming year.

1. Simplified Regulatory Procedures

Vagueness and uncertainty towards regulatory procedures is a reason for a slowdown in the number of clinical trials approved in India. But new updates are making the approval method faster, predictable and with global practices.

Revised guidelines permit to pay compensation only up to the point that the drug caused an adverse reaction in a patient who participates in the trial. This is a significant change compared to the previous rule.

Regulatory procedures also cleared that audiovisual recording of informed consent is not a must, in every case.

The Central Drugs Standard Control Organization or CDSCO has set up online licensing portal SUGAM in March 2016 for importing and registration of drugs and medical devices. The online services are extended to the pharma companies to submit and apply for clinical trials also.

2. Encouraging the Local Stakeholders in Clinical Research

A new circular released by CDSCO has also removed restrictions that stopped investigators to conduct more than 3 clinical trials at a given time period. The DCGI has put the responsibility on the Ethics Committee to take into consideration the complexity and nature of the clinical trials and grant permission in accordance.

The Indian government also revised the compulsory requirement that clinical trials can be done at the sites that have over 50 hospital beds. The Ethics Committee can now decide whether the trial site is suitable or not. It is compulsory that the site has an emergency medical care and rescue arrangements which is essential for a clinical trial.

3. Latest Proactive Initiatives by the Government

In order to create a niche for India on the global map of clinical research, the Drug Controller General of India is also considering to provide online NOC to pharma companies to carry out clinical trials in India.

If this happens, relevant documents could be submitted online which reduces the time and effort needed to submit hard copies at the office.

The government also has a goal to speed up approvals, remove mediators and bring more transparency to the new guidelines. Simple and lee troubling application processes could streamline the clinical trial sector and attract global companies to India.

4. Growth in Global Incentives

The US remains the biggest drug market with an estimated market value of about US$ 413 billion in 2015. The FDA regulates the US drug market and Indian pharma companies and CROs also have to abide by FDA norms and regulations. With the election of Donald Trump as the US President, the policies will have an impact on Indian pharma and clinical research sector.

The President has voiced his support for effective, safe and cheaper drug imports and this could boost the Indian pharma companies which supply about 40% of the overall generic drugs consumed in the US. Trump has also promised to increase funds towards research agencies which include the National Institute of Health (NIH).

Conclusion

Indian clinical research sector has quite a strong basis which includes a genetically diverse patient pool, a vast population who needs medical treatment, efficient medical professionals, clinicians and data experts, and good regulatory practices. Though the industry has taken its own time to reassemble after the introduction of new regulatory practices, it is all set for exponential growth now.

With this, we conclude.

Are you looking for a clinical research career?

To be successful in this competitive world you need cutting-edge technical training. Among the top institute for clinical research in Pune, CRB Tech Solutions created a good name for itself. We offer one of the best clinical research courses in Pune. The course offered by us is industry oriented and scientifically programmed.

If you want to enrol on a top institute of clinical research in Pune, CRB Tech Solutions would be your right success partner.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field

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The Significance Of Clinical Research In The Future of Cancer Treatment

Clinical research or clinical trials are significant in making new findings in the field of oncology and its researchers. Dr. Nicholas Vogelzang, a medical oncologist at Comprehensive Cancer Centres of Nevada said that every advancement in cancer treatment in the past 50 years is the outcome of research. In this blog, we shall discuss how clinical research can potentially benefit the humankind.

Clinical-Research-Is-Important-for-the-Future-of-Cancer-Treatment

Clinical Research for Cancer Patients

Cancer research studies include experimental treatments or combinations of treatments and provide specific advantages for cancer types offered to eligible patients.

According to the National Cancer Institute, clinical research helps physicians to find new and improved ways deal with cancer care and the wellbeing of a patient.

Each study seeks specific answers and to find better ways to avert, diagnose, or treat cancer. In a clinical trial, doctors and researchers monitor the patients closely, throughout the treatment process to demonstrate if the novel drug or treatment method is safe and if it works better than what is available to cancer patients.

Benefits of Clinical Trials

Clinical research gives the patients an opportunity to play an active role in their treatment plans and permits patients to help others by improving cancer treatment for patients in the future. Here we share some more information regarding clinical research:

1. They offer close monitoring & testing

Participation in a clinical trial often needs extra attention from a dedicated team specifically created for your trial. During testing of new drugs or treatment, it essential to monitor any potential side effects. To mention that, at any point, if a patient begins to experience negative side effects, you need to withdraw from the trial.

2. A better access to treatments currently not on the market

The main purpose of clinical trials is better the process of care for patients going through cancer treatment.

To find a novel drug or therapy and then getting it approved for commercial use is a lengthy method. For instance, every new treatment must go through a series of trial phases before submitted for approval of the FDA and finally eligible for commercial sale. Participation in clinical trials can provide the patient quicker access to those therapies, which could be more effective than the presently available ones.

3. Help with valuable information which can help others

Owing to clinical research, doctors and cancer researchers know more about what works and what doesn’t, to treat cancer. Clinical trials are the best way to find out which treatments are successful and which needed improvement. Information collected during clinical trial adds to valuable information about cancer. This information can help the researchers understand the different cancer types and can possibly be of help in saving lives in future.

Comprehensive Cancer Centers of Nevada built huge clinical research program which brought groundbreaking clinical research studies to the Southern Nevada. They participate in over 170 Phase I, Phase II and Phase III clinical research studies every year. They are honored to be part of successful research and have contributed to the development of over 60 FDA approved cancer therapies which include the recent approvals for Tecentriq, Xofigo, and Opdivo.

Are you looking for clinical research training in Pune? To be successful in this competitive world you need cutting-edge technical training. Among several good organizations, CRB Tech Solutions created a good name for itself. We offer one of the best clinical research associate training.

If you are trying to find top institute of clinical research, CRB Tech Solutions would be your right success partner.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field

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Cutting Edge Clinical Trials For Gynaecologic Cancers At Wilmot Cancer Institute

For about five months, Christine Snyder has been travelling from her home to the Wilmot Cancer Institute to take part in a clinical trial. Synder is a patient with ovarian cancer says that to be involved in a clinical trial is not insignificant to her by any means. She said that she has firm belief in the research and anything that can be done to evade cancer.

New-Clinical-Trials-Advance-Treatment,-Diagnosis-of-Gynecologic-Cancers

She goes there every 3 weeks for treatment as a part of an ongoing study to assess whether chemotherapy alone could be as effective as chemo and surgery for repetitive ovarian cancer.

The trial is among the several which were opened in 2016 at Wilmot through the National Cancer Institute and NRG Oncology, a non-profit cooperative group that carries out and leads clinical research with institutions in the country. These trials address pertaining questions regarding treatment for gynaecologic cancers, like cervical, endometrial and ovarian. In addition to the national treatment trials, Wilmot also provides trials which are available only in Rochester, and that includes one which is evaluating potential molecular biomarkers for risk prediction of a pelvic mass that becomes cancerous.

Sajeena Thomas, M.D., said that they are a part of a movement to change the future of gynaecologic oncology. And continued that it is phenomenal to give patients trials that will play a role in shaping which will become the standard of care giving.

For several gynaecologic cancers, progress in survival has been slow, and there have been very few advances in the last decade. Researchers are into finding options beyond the conventional chemotherapy, and many of the trials at Wilmot mainly focus on targeted therapies. Chemotherapy cannot relatively discriminate with its impact on cancerous cells and normal cells; there targeted therapies can act on specific genes or other bio molecules responsible for the growth, progression and spread of cancer.

Richard Moore, M.D, said that they are presently learning more about how cancer develops, what are their weaknesses and ways to exploit them. He said that regularly, new targets are identified and so also novel drugs that can successfully target them.

Among the novel class of drugs are the PARP inhibitors, which block an enzyme in cancerous cells that help to repair damaged DNA. These under trial drugs are showing promises in delaying the repetition of ovarian cancer among women who carry BRCA gene mutations and for those with different genetic profiles.

Moore said that at a centre like this, it’s essential to offer a community cutting-edge care and allow an access to drugs which are not widely available.

Though targeted therapies and precision medicine are very promising, their very nature means they don’t work on every cancer, and Wilmot scientists are looking for more and better possibilities.

Moore leads a team for Gynaecologic Cancers who are on the verge of finding new molecules that one day could become therapies that leverage various features of tumours. For example, they focus on molecules which could counteract a protein called HE4, a marker for ovarian cancer.

Their team is also part of a clinical trial studying tumour cells which circulate the blood of women who have a pelvic mass. Their aim is to identify biomarkers and formulate a test that uses them and estimate the chances of the mass are malignant. Wilmot is the only site in the U.S. to take part in this study and a parallel study is being conducted in Europe as well.

With this, we conclude. Keep looking into this space for more informative articles to come.

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SOPs-For-Clinical-Trials-And-Their-Significance

SOPs For Clinical Trials And Their Significance

Today in this blog topic we would discuss SOP or Standard Operating Procedures and know their significance in the field of clinical trials.

SOPs-For-Clinical-Trials-And-Their-Significance

What are SOPs?

Standard operating procedures or SOPs are written instructions created to document how to perform a routine activity. Many companies depend on SOPs to ensure consistency and quality products. SOPs are also useful tools in communicating important corporate policies, government regulations, and the best processes.

In the area of clinical research, SOPs are created to bring uniformity to the research policies, operating and finance methods, and are utilized by sponsors and clinical research programs to establish standard and general methods common to all running studies.

SOPs are significant in efficiently managing clinical trials operation while assuring optimal compliance. SOPs include comprehensive descriptions of every aspect of a clinical trial operation that includes patient consents, storage of drugs, handling of specimen and enrolment.

In short, they are perfect fit in clinical research programs and stricken clinical trial regulations to guarantee Good Clinical Practices or GCP.

What purpose do they fulfil?

If a person works in a clinical research program, he or she has to follow the SOPs. With complete SOPs in place, a research member will well understand the processes and procedures that lead to a better streamlined and a consistent program. The SOPs of a research program also serves as an evidence for external regulatory agencies and sponsors that the research program is well run and under good operation.

Some instances of essential SOPs include the Research Policies, Operating, and Finance Procedures, as mentioned below:

Informed Consent Practice

Maintaining Regulatory Files and Subject Records

Audit Preparations

Clinical Trial Management System (CTMS), Entry of Subjects and Reporting

Clinical Research Education Needs

Recruitment of Patients and Advertising

Reporting Protocol Deviation

And lots more……

Are SOPs beneficial every time?

SOPs are almost and always beneficial to a research program. The only time SOPs are not helpful when they are not followed or used. To mention, FDA regulations don’t need the SOPs for sponsors and clinical research programs, while other programs can be quoted as having SOPs but not following them. So, avoid creating SOPs if you have no plans of following them. And, in case you create an SOP, ensure that this is being followed by the people in your research team or organization.

In short, SOPs is one of the most beneficial tools in clinical research practice. If you adhere to institutional SOPs it could create a difference between a well complying and financially viable study and one which is stuck in redundancy and is a waste of time.

With this, we conclude. Keep looking into this space for more informative articles to come.

Among several good organizations, CRB Tech Solutions created a good name for itself. We offer good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune.

It has earned a good name for itself among the Institute of clinical research in Pune, who offers the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand for proficient candidates. For better career goals, you should join institutes with good clinical research training program.

If you are trying to find clinical research courses in Pune, CRB Tech Solutions is one step ahead of your success.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter