Monthly Archives: June 2016

Clinical Data Management Course and Certification Programs

 

Clinical Data Management Course and Certification Programs Clinical Data Management (CDM) is an essential phase in clinical research, which leads to production of reliable, high-quality and statistically pretty sound data from clinical researches. CDM assures collection, integration and availability of data at appropriate quality and expanse.

Clinical Data Management includes the conduct, management and analysis of studies across the spectrum of clinical trials. Pharmacovigilance (PV) is also known as Drug Safety, It is the approach of making an assessment, understanding, detection, and prevention of inappropriate effects or any other problems related to drugs . As such, PV mainly focuses on adverse drug reactions , which are defined as any reaction to a drug which is fatal and not intended, including lack of efficacy.

The main aim of the training is to make the candidates employable as Clinical Data Manager , CDM Specialist, Medical Advisor, Pharmacovigilance Expert/Scientist,CDM Data Analyst, Clinical Data Coordinator, etc in Pharmaceutical companies, Clinical Research Organizations (CROs) and Support Staffs for Clinical Data Management services to various clients related with Clinical Research etc. The Program gives a solid introduction to CDM and PV domain for other potential players in the industry such as pharma scientists, medical practitioners etc. The program might be of of one month to maximum six months duration, depending on the institute of choice. The unique combination of solid theoretical and thorough practical training ensures the employability of the candidate immediately on completion of the Program. Current or an aspiring medical professionals keen in becoming clinical data managers or clinical research associates can enlist in a Clinical Data Management Certificate program.

A certificate program in clinical data management gives an understanding of how clinical trials of pharma and medical products are designed and employed. Prospective students should have a basic knowledge of natural and practical sciences.

Since Clinical data managers coordinate and supervise clinical trials that evaluate novel pharmaceutical drugs and medical devices; so courses in a program cover scientific, clinical, regulatory and project management topics related to medical research. They also complete fundamental training in communications and management . Some specific courses might include:

  • Drug safety

  • Clinical trial design

  • Monitoring clinical trials

  • Human subjects protection

A clinical data research associate or a clinical data manager can work for various organizations in pharma and health-care . So types of companies hiring such professionals include biotechnology organizations, pharmaceutical companies, hospitals ,academic medical centers and federal regulations departments.

Employment Outlook and Salary Information

As per sources and reports, clinical data managers as statisticians can expect 27% employment growth during the 2012-2022 decade, which is about as fast on an average. The Payscale.com mentioned in May 2015 that clinical data managers earned between $38,985 and $102,907 per annum, with the median salary being $67,138. In the race of many institutes and organizations CRB Tech Solutions has it own name in offering trainings on Clinical Trials and Clinical data Management.

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

Related Topic:

1) How Clinical Research Management Can Help You?

2) Get hired quickly as clinical research professional

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What is Clinical Research Organization and jobs in a CRO

What is Clinical Research Organization and jobs in a CRO A Clinical research organization (CRO) is an organization that provides support to the biotechnology, pharmaceutical and medical device industries in the form of research services outsourced on an agreement basis. A CRO may provide such services as biopharmaceutical development,commercialization,biologic assay development, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, universities, research institutions and in addition to governmental organizations.

What is  Clinical Research Organization and  jobs in a  CRO

Allen does Stage I medical studies for a living. She works for Quintiles, a legal agreement analysis company (CRO) that associates with pharmaceutical organizations to accelerate the medication of growth procedure. In Allen’s calculation, the common medication expenses £900 thousand via the growth levels, which could take 10–12 years. Now with improving expenses and many strict rules, sections of the growth direction are progressively managed by pharmaceutical companies. This is where CROs play their role.

So what is a CRO?

A CRO is an independent organization that gets into the development process once a pharma company has identified a promising novel molecule. The top CROs, according to outsourcing-pharma.com, are Quintiles, INC Research, Parexel,PRA Health Sciences, Pharmaceutical Product Development (PPD), HMR Covance, Meditrial Europe, Medpace, inVentiv Health, and Chiltern. Basically, a CRO will organize and conduct clinical trials to test the novel molecule in humans. Being independent companies, they offer objective assessments of a novel drug in the clinical setting and since they are partner with many companies, they typically offer broader experience compared to an organized trials by the pharma company themselves.

How is it like?

The role of a CRO is very challenging, demanding and also highly rewarding, playing a key part in improving the lives of thousands of people. They create a difference in mass !

So the people in a CRO has a very tenacious role, even stressful for some and certainly requires a high degree of responsibilities. Since the entire clinical research deals with people’s lives, so they have to be very careful.

How do get a job in a CRO?

In order to get a job at a CRO, you should have a first degree or higher or have a relevant experience e.g. several years in a clinical setting. One should should read everything on about clinical research and regulation; also the ethics. A starting tip is to see what is GCP, GLP and GMP and learn all one can about them.

The entry level Clinical research associate (CRA) might expect a salary in the high £20K to low 30K range, and this can soon increase to >50K with experience and with extra responsibilities. Now if carrying out a clinical trial sounds a little scary after the safety of the academic lab bench, plenty of on-the-job training will be offered to ease the transition. One can also gain plenty of project management and business skills that are highly transferable to other organizations.

A significant portion of R&D budgets are spent on outsourcing services either domestic or international; offered by the CRO industries, approximately $25 billion in 2015. And this figure is expected to grow at 9% over the next nine to fifteen years.

There are over 1,100 CROs in the world, despite continued trends toward integration (i.e. many CROs are being acquired in recent times or others go out of business).It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008 and down to 55% in 2009. One estimates had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

CRB Tech Solutions is a leading clinical research training institute and offer best in class job oriented clinical courses to help launch your career.

Pune is booming with pharama vacancies, so if you want a clinical research career you need to improve your skill set to beat the competition.

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

Related Posts:
1) Top 10 Clinical Research Companies in Pune

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

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Pharmacovigilance (GpvP) Training

Pharmacovigilance (GpvP) Training 

Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.

The roles of pharmacovigilance jobs mainly focuses on serious drug reactions, or ADRs, which are defined as any reaction to a drug which is noxious, unintended and includes lack of efficacy . Medication errors such as overdose, misuse and abuse of drugs as well as drug exposure during both pregnancy and breastfeeding, are also of interest, even without an inappropriate event, because they may result in an adverse drug reaction.

Pharmacovigilance is the technology and actions about the recognition, evaluation, knowing, and protection of negative effects or any other possible drug-related problems. Lately, its issues have been increased to include herbals, blood products, traditional and complementary medicines, biological and medical devices and vaccines.

You need to get trained to ensure drug safety. The Pharmacovigilance training provides solid practical foundations for peopleworking in drug safety and is of benefit to staff working in the clinical research organizations and to a broad range of staff in the clinical research industries and regulatory authorities. Attendance under this course can be used as a part of the training required for the Drug Safety Surveillance module of the Pharmaceutical Medical Speciality Training (PMST).

Informations received from patients and health-care providers via pharmacovigilance agreements (PVAs), and other sources such as the medical literature; play a critical role in conferring the data necessary for pharmacovigilance to take place.

The topics covered under Pharmacovigilance training include :

  • Drug safety

  • Global regulatory requirements

  • GpvP audit

  • Signaling and risk management

  • Device safety and vigilance

Importance of such training:

The upcoming clinical research sectors need an inspection on novel products and the way they are being produced after the whole process of clinical research being carried out. In many countries, if the authorities are unsatisfied with an inspection then they have powers to seize product, issue sizable fines and even launch criminal proceedings. So a course certificate through a training enables you to quickly demonstrate that the staff has undergone an appropriate training and helps gives an idea that your company has appropriate pharmacovigilance systems in place.

Who should apply for the pharmacovigilance training courses?

The trainings are aimed at personnel treat with the safe use of medicines, mainly in developed countries, including those working or are intending to work in the pharmaceutical industries involved in drug development, licensing and surveillance ; the regulatory bodies who are involved in licensing and inspection ; the health service who are involved in drug policy and health policy decision-makers.

Amidst the race of many institutes and organizations CRB Tech Solutions has a name in offering Clinical Research Training.

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

Related Topics:

1) Pharmacovigilance: Common terms used in drug safety

2) Pharmacovigilance scope

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Innovative Clinical Research Institute In Pune

Innovative Clinical Research Institute In Pune The CRB Tech Institute of Clinical Research is a unique year-long education, learning and guidance system for fellows with biology background. It provides a broad education and learning on clinical research methods, research partnerships and managing the demands of family and profession. The goal of CRB Tech Institution is to produce a team of researchers armed with suggestions for clinical research carrying out innovative clinical trials and access to sources to make their concepts a reality.

CRB Tech Institute for Clinical Research was established mainly to plan & conduct academic programs for Health professionals. CRB Tech represents hope amidst many doubts for those who are willing to pursue clinical research careers. True to its motto CRB Tech aims to meet the needs of health-care professionals who may encounter a high risk condition in the daily medical practice. It is one of the leading training organizations in the field of Clinical Research.

A venture of Annex Group of Companies, CRB Tech was started to bridge the gap between industries and aspiring candidates from dynamic start-ups to Fortune 500 companies, CRB Tech has an answer to every recruitment need. But now extending its goal, CRB Tech is gradually coming up as an answer to your search for the most innovative clinical research institute and running in the race of many clinical research organizations. With the perfect balance between talent and professionalism, we have become the workforce leader you can depend on.

Our work shop focuses on the foundation, strategies, and application of patient-oriented clinical research. We are starting with new projects and ideas to contribute in a novel way to the society. Throughout a few days the participants create their own proposed patient-oriented clinical studies, refining and changing their plans through connections with staff and colleagues.

Our summer classes are divided into didactic classes and little number of meetings. The days are dedicated to lessons on patient-oriented clinical research methodology and related topics, while in the days participants meet with their little groups, perform shop guides and other staff, such as biostatistics, to perform on protocol development. Informal presentations by management in clinical research take place in the evenings.

CRB Tech also provides a Clinical Research Training and Recruitment Program

As per study conducted in the pharmaceutical sector, the major reason for not finding a job in this sector is having only theoretical knowledge of the sector by the candidates who apply for the available positions. Thus we came up with this program in collaboration with our tie-up companies to give candidates the applied knowledge of the sector so that they find suitable jobs.

The regular PG courses for clinical research and and relevant fields available in the market provide the candidate with only the theoretical knowledge of the sector. We have designed and developed this program solely to prepare a candidate for the jobs available in the industry. Thus our program comes with a 100% Job guarantee and placement.

Our CRTI (Clinical Research Training Institute) system provides individuals the chance to talk about the principles of clinical research design and execution. It would help you recognize the moral and regulating issues of clinical research. Help you examine the fundamentals of subjective presentation, competitive grant writing, and manuscript preparation. CRB Tech demonstrate the

improvements in the quality of own research proposals through input from staff and colleagues. CRB tech comes up with methods for seeking and developing a successful profession in clinical research.

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

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

Related Topics :

1) Top 10 Clinical Research Companies in Pune

2) CRB Tech in Clinical Research: Making a difference

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Top 10 Clinical Research Companies in Pune

Top 10 Clinical Research Companies in Pune  The clinical trial industry is gaining continuously a positive metamorphosis in India. Now the clinical trial processes are being viewed as drug discovery rather than drug development destination only. At present, several companies are looking at the innovation. And rise of these companies have led to many more openings for clinical research job in Pune and India as a whole

top-clinical-research-company-in-pune

The famous players of Pune among the clinical research organizations are:

1) Lupin is one of the fastest growing pharma company in the world. Started in 1968 under the leadership of Dr. Desh Bandhu Gupta’s with a vision to fight against fatal diseases. Lupin first came in limelight when it became the largest manufacture of TB drugs.

2) Serum Institute of India is a prominent pharma company, with headquarter in Pune. It is the part of the Poonawalla group and headed by Cyrus poonawalla. Serum was started in 1966 and has 40 + years of experience in pharma industry.

3) TCG Life sciences Limited is a foremost pharma research company that was started in 2001 and has presence in US, Europe, Japan and Australia. TCG has a pool of 800+ talented professionals that work across different platforms and contribute in the company’s success.
Leading Mumbai based clinical research company ‘Clininvent’ is the subsidiary of TCG that has strongest network of clinic and hospitals.

4) CRB Tech Solutions is gaining prominence with its able Certification Program that has qualified more medical scientists around the country since its beginning in early 2000s.Crb tech enables with live clinical sessions at lab and with its updated infrastructure its marching to run the race among the best companies.

5) Emcure Pharmaceuticals is a well known pharma company in India. Established in 1983, it has headquarter in Pune. Company has an excellent team of 9000 professionals that manufactures softgels, injectable tablets, capsules, Lyophilized sterile parenteral, and onco products.

6) Pentagon Research Pvt. Ltd. is one of the fastest growing CRCC (Clinical Research Coordinating Centre) in India. It is known for a dedicated support team of site management, powerful understanding of the protocol & ICH GCP, famous for providing additional number of patients than demand with quality work.

7)Maple Biotech Pvt Ltd is another prominent name in pharma industry. Company was started in 1985 and has 25 years of experience in manufacturing pharma products. Maple biotech has huge product line that include Low substituted Carmellose Sodium, Sodium Starch Glycollate, HPMC Phthalate, Cellulose Gel, Croscarmellose Sodium Alpha Cellulose, Pre Gelatinized Starch, Sodium Stearyl Fumarate, Microcrystalline Cellulose, Calcium CMC, Oxycellulose , Cellulose Acetate Phthalate

8) Acton Biotech (India) Pvt. Ltd is also a growing pharma company that deals in medical genetics. With Sandeep Saxena as its head the company has over 10 years of experience in Genetics Research, Bioinformatics, Sales and Marketing.

9) Bilcare is a leader in packaging solutions to pharmaceutical companies all over the world. They offer innovation-led packaging solutions that maintain the quality of drugs and protect brands and ensure the delivery of genuine medicines to patients. They offer widest range of specialty Polymer Films and Aluminum Foils for packaging of solid dosage pharmaceutical products. Their packaging solutions are affordable and sustainable. They have Research and Development centers located at India , Singapore and Germany, which has best of talent and always comes up with novel and innovative products.

10)Indus Biotech Pvt. Ltd. was established in the year 1997 and is a consumer healthcare products research company. Their main focus is on innovating and developing healthcare products for CNS, Infectious, Lifestyle and autoimmune diseases. They have developed various products such as “TORABOLIC’, which is a mass building dietary supplement for lean people, “TESTOSURGE”, which increases bio-available testosterone, “BIOCREAT”, that increases supply of Creatine to muscle tissue and increase its bio-availability without the intake of any sugar, “TESTOFEN”, which is a standardized fenugreek extract and increases libido.

The above mentioned list of companies could help you finding pharma jobs in Pune.

If you want to make a clinical research career, then among many renowned 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 Post

1) Clinical Research Jobs in Pune

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

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Clinical Research Coordinator Training Programs And Its Requirements

Clinical Research Coordinator Training Programs And Its Requirements The Clinical Research Coordinator or CRC is a specialized research professional working with but under the direction of the clinical Principal Investigator. Though the Principal Investigator is mainly responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, ease and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these tasks, the CRC works with the principal investigator(PI), sponsor and institutions to support and guide them on the administration of the financial, personnel and other relevant aspects of the clinical study. The CRC reports to the PI.

clinical-research-coordinate-training

The majority of these professionals has a bachelor’s degree in their field, although some earns their Master’s degree.

Education required Undergraduate degree; Master’s is desirable
Other Requirements Clinical Research Coordinator (CRC) certification
Median Salary (2015) $55,440**

Workplace of a Clinical Research Coordinator

Research coordinators mainly work in clinical research facilities. The workplace has a team ambiance, with clinical research coordinators working closely with a team of clinical research associates they are responsible for supervising. CRC also work closely with the principal investigator of their research facility to ensure that the trial follows every ethical guidelines.

Clinical Research Coordinators recruit and screen patients for trials, ensuring that the study adheres to safety and government regulations, monitoring patients and reporting study results. Clinical research coordinators might also be responsible for obtaining grants to fund the study.

Though the U.S. Bureau of Labor Statistics does not maintain records for clinical research coordinators, it did report that there is an employment growth between the years 2012 and 2022 for clinical laboratory technologists and expected to be 14% while growth for clinical laboratory technicians are expected to be a significantly higher 30%.

As of February 2015, that the median annual salary for clinical research coordinators has been $55,440 : Source Salary.com

Training Requirements

Due to the medical nature of the job, clinical knowledge with experience is important for future clinical research coordinators. Individuals might choose from a variety of training or degree programs to enter the clinical research field.

According to the reports of O*Net Online in 2013, 56% of clinical research coordinators held at least a bachelor’s degree, while some 12% had a master’s and nine percent had an associates degree

Training Programs

An undergraduate degree program in clinical research, e.g. an Associate in Applied Science in Clinical Research Coordination or Bachelor of Science in Clinical Research, can help individuals meet the required eligibility criteria for an entry-level clinical research position. These degree programs typically include coursework in biological science, medical terminology, case studies, clinical monitoring and ethics.

Master’s degree programs, like the Master of Science in Clinical Research and Regulatory Administration, can help prepare for higher positions through coursework in leadership, research conduct and clinical trial recruitments.

People who already has a degree in a clinical field, such as nursing, might want to pursue a certificate or diploma in clinical research. These programs typically focus on the specific tasks required of clinical research coordinators. Students might be expected to have previous knowledge of clinical subjects, such as patient monitoring and medical terminology.

Certification

The Association of Clinical Research Professionals (ACRP) gives voluntary Clinical Research Coordinator (CRC) certification for individuals with at least two years of experience in clinical research or a closely related field . The educational requirements though vary with the candidate’s quality and quantity of work experience. Eligible candidates should submit proof of education and work experience, pay an exam fee and need to pass an exam in order to receive the CRC certification.

CRB Tech Solutions is a leading health care Clinical Research Coordinator Training institute and offer best in class job oriented clinical courses to help launch your career.

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

Related Posts:

1. 6 Ways ResearchKit Would Change Clinical Research

2. Top 10 Clinical Research Interview Questions

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Digital Health A New Approach For Rare Disease Management And Researches

Digital Health A New Approach For Rare Disease Management And Researches

While digital health is yet in its infancy within the clinical research field, discussion on the improvement of trial design and its potential for rare disease subjects is very exciting.

Rare disease management presents big challenges for patients, families and clinicians. Now clinical management system is at the forefront as a potential game changer in the clinical research industry. Mobile technology such as ResearchKit could efficiently alter the conduct of clinical trials, including key operations like subject engagement, trial design and data collection.

While with many applications there are expecting many effect on all therapeutic areas, one notable being the potential benefit to rare disease research. The capabilities of mobile technology for rare disease studies could ease unique operational difficulties, improve researches and increase quality of life for subjects.

1. Longitudinal studies are

research methodologies in which the same people are studied for over longer periods of time. Advantages of this study design includes the opportunity to examine natural history of human behavior, emergence and progression of disease, and the effects of various interventions over years and decades. Perhaps the most famous and significant study of this type is the Framingham Heart Study which began studying with a local population in Massachusetts in 1948. It was started to determine risk factors for cardiovascular diseases. In 2002 the study began examining the third generation of the original participants. This type of studies are critical in understanding rare disease which require data pooled from as many patients as possible.

This study proved that longitudinal studies are attainable over many decades and they can produce significant results from accumulated data. Digital health tools today have the ability to gather data from huge patient populations real-time. Thus can result in the discovery of rare diseases too.

2. Under-discovered data

There is no bigger waste than important data which is stagnant and/or undiscoverable. The importance of this model is amplified with rare diseases. Analytics give life to data because it is presented in useful and understandable ways and could, with some technologies, be customized spontaneously with regards to type of data collected or presentation.

3. Incorporation of genomics in registries. Genomics has played an important role in the discovery and ongoing expansion of knowledge bases in rare disease. The US Department of Health and Human Services has a Genetics and Rare Diseases Information Center for the public and has established the Rare Disease Clinical Research Network which has over 20 rare disease research consortia. This will facilitate the sharing of the complete array of data pertinent to these patients among providers and experts.

4. Involvement of caregiver

The proliferation and success of documentaries and films about rare diseases speaks to the human experience pertinent to all patients and caregivers in the field of rare diseases. Many of these films reveal the importance of shared experience. Social media groups are proving essential tools for engrossing information among caregivers.

5. Comprehensive communications and monitoring tools

Digital communication can take many forms like it can involve the initial transmission of data or teleconference between a referring physician to an expert. It can include messaging of symptom status with transmission of remote monitoring data between peers and updates of developments in researches or inferences among researchers, or the exchange of messages among caregivers.

Rare diseases present many problems to both the patients and caregivers along the entire journey from per-diagnosis to referral to an expert and to determining best care. The best care might not be still determined due to the rarity of the disorder.

If you would like to add anything to the topic, you can leave your thoughts, ideas and experiences in the comment section below.

CRB Tech Solutions is a leading health care training organization and offer best in class job oriented clinical courses to help launch your career.

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

Related Topics:

1) Clinical Research for Parkinson’s Disease and Placebo Effect

2) Clinical Research for Probiotics

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Tips To Ace Clinical Research Associate Job Interview

 Tips To Ace Clinical Research Associate Job Interview  

Are you seeking for clinical jobs as a clinical research associate

Here we give you some tips and tricks to crack a clinical interview…..

Preparation is an inevitable prerequisite for performance. So prepare yourself to sell employers not only on your scientific knowledge but also on your attention to details and your capabilities to work in a team.

Role of a Clinical Research Associate (CRA):

  • Oversee clinical trials

  • Monitor the results

  • Ensure that everyone and every step involved follow proper guidelines

…..So portray yourself as a well-rounded science professional with sound judgment , excellent organizational and people skills.

Steps :

(1) First research the organization you are to be interviewed with. Employers often ask why did you opt for that position or why you want to work for the organization. If you don’t have a thorough answer, they might assume you’re not seriously interested in the research the organization specializes is carrying out. In addition, if you don’t have an in-depth understanding of the company’s mission, you even can’t explain why you’re a good fit. Why should they choose you in comparison to others. Browse the corporate website and take a look at the company’s previous research work, read news and related articles on the company and talk to current and former employees, as an extended affort.

(2) Outline how you meet the requirements listed in the job posting. A clinical research associate is a highly specialized role, so it’s important to customize your interview replies to the specific job responsibilities. E.g. the employer might want applicants with extensive knowledge of a certain disease or expertise in a certain type of test or analysis. Find several examples that demonstrate how you meet each qualification or specification. If by chance you lack any requirements, detail how your previous job experience would help you to apply for the position or how you can quickly be rapid in grasping the subject.

(3) Take time to review the latest news, researches and other scientific developments that are quite applicable to the job. Clinical trials are at the forefront of medical research, so it’s important to show employers you can keep up with this rapid and developing field. If you’re interviewing for a position with a company that specializes in breast cancer research, for example, prepare yourself to discuss other trials conducted within the last three to five years. Note any hopeful developments and describe how you consider that they might mean for the future of treatment in cancer.

(4) Make sound preparations about your prior research so you can discuss it in-depth with employers. Many interviewers will ask you to describe previous clinical trials you’ve assisted with and detail on your role and the results. So detail your role step-by-step and explain the nature of the trials. Even select several examples that illustrates how you resolved difficult situations or discovered errors or any other potential problems. It would be an advantage if you also highlight how you collaborated with others while working on the project and how you ensured that the trial remains on track.

(5) Last but not the least strengthen your technical knowledge. Interviewers will likely want to evaluate your technical skills, so brush up on the topics you came across in the textbooks. You have to very sound at theoretical knowledge besides practical hands on. Employers might test and analyze you on your proper understanding of research protocols and procedures, or might check your knowledge of biology , chemistry and some other disciplines crucial to the organization’s research.

A Clinical Research review by CRB Tech Solutions would help you to improve your insights about the field and excel in your career ahead.

Related Topics:

1) Job description of a Clinical Research Coordinator

2) Clinical Research Associate Training | Jobs In Pune

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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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Differences Between Clinical Research And Clinical Practice

Differences Between Clinical Research And Clinical Practice Clinical research is a current knowledge-oriented and booming industry. It is one of the industry growing at an amazing rate and widening the scope of employment opportunities for trained people. It includes scientific analysis of the risks,impacts and benefits of medicines or a medicinal product. The trials are performed before initiating the products to the market. The tests are performed at different stages and after-delivery supervision is maintained to scrutinize the safety and monitor the side effects if any.

diffrence-between-clinical-research-and-clinical-practice

A Good clinical practice is an international quality standard that is provided by ICH, a global body that defines standards, which various governments can exchange into regulations for clinical trials involving human subjects. A similar guideline for clinical research on medical devices is the international standard ISO 14155, that is valid in the European Union as a coordinated standard. These standards are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of advocacy in clinical guidelines.

Clinical Research Clinical Practice

In Clinical research special training is needed, it must be conducted according to the written protocols with a full understanding of the risks to the subjects. The regulations,laws and guidelines for Clinical Research are detailed and specific.

Clinical Research includes any experiment that involves a test article and one or more human subjects.

It might be any experiment in which a drug is administered to or used involving, one or more human subjects. For the same purpose, an experiment is any use of a drug except for the use of marketed drugs in the course of medical research.

Clinical Practice: It is to exercise an occupation or profession

No protocols are required; can be administered to all patients. Some documentation is needed, It is not intended to publisher and billable to insurances.

Clinical Research: It is systematic investigation designed to contribute to generalizable knowledge

I needs protocols; it is administered to some patients. Much documentation is needed,intended to publish and not billable to insurance.

Clinical Trials Vs Medical Practice

Clinical trials are not to evaluate a medicine under actual practice conditions,but rather under selected and often artificial conditions to answer best the trails’ objectives.

Controlled clinical trials by definition cannot mimic actual medical practice conditions.

Medical Practice

The practice of medicine combines both science as the evidence base and skill in the application of this medical knowledge in combination with intuition and clinical judgment to determine the treatment protocol for each patient.

There is off-label use of biologics, marketed drugs and medical devices.

If physicians use a product for an indication not in the approved labeling they have the authority to be well informed about the product, to base its use on firm scientific rationale and on good medical evidence and to maintain records of the product’s use and effects

However the institution at which the product will be used may, under its own authority , require institutional reviews and insights.

Clinical Trial

Includes a comparison test of a medication or other medical treatment, versus a placebo , other medications /devices, or the standard medical treatment for a patient’s conditions

Researcher tests hypotheses and observe what happens. Clinical trials can be viewed as the application of the scientific method to understand human biology.

Clinical trials are closely authorized or guided by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by an ethics committee before permission is granted to run over the trial.

Clinical Practice

The investigation and use of approved marketed products differs from off-label use. Investigatory use suggests the use of an approved production in the context of a clinical study protocol. When the principal intent of the investigatory use of a test article is to develop information about the product’s efficacy or safety , submission of an IND or IDE may be required

Clinical Research review by CRB Tech Solutions is quite good for you to make you consider and take up a career in this field.

Related Topics:

1) Top 10 Clinical Research Interview Questions

2) Types Of Clinical Trials And Its Significance

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