Tag Archives: clinical research coordinator

How Clinical Research Management Can Help You?

A scientific analysis manager conducts analysis, investigations and tests of protocol subjects and participants. Their responsibilities consist of collecting data and monitoring the results of the scientific tests. Clinical analysis planners also collaborate with other medical managers in the implementation of scientific tests and the recruitment process of medical trial participants.

Work Experience

To become a scientific analysis manager, applicants for these positions should have prior encounter as scientific analysis experts. Understanding the scientific analysis process and participating in scientific tests are important attributes that companies may need applicants for the job to have. The degree of scientific analysis encounter needed to qualify for a job as a scientific analysis manager is determined by the companies. Some companies may need only one to two years of scientific analysis encounter, while other companies pursue individuals with additional years of encounter.

College Education

Many companies may seek applicants for the scientific analysis manager place who possess an associate’s or bachelor’s degree in scientific analysis. Having a degree in scientific analysis, coupled with less than one to two years of expertise in scientific analysis, may meet adequate minimum qualifications with some companies.

Because scientific analysis planners prioritize and oversee the development and implementation of scientific analysis tests, many companies need them to be licensed as a registered nurse or a licensed practical nurse. Many companies who seek applicants with an RN or LPN license may also need them to have at least one year or more nursing expertise in a medical facility.

Certification

Certification also benefits applicants for scientific analysis manager positions, and some companies need applicants to have a documentation in scientific analysis from approved organizations that offer documentation courses and examinations. The Society of Clinical Research Associates and the Association of Clinical Research Professionals are nationally recognized organizations that offer documentation programs for scientific analysis experts.

Additional Qualifications

Many companies need individuals to be proficient with Microsoft Word, Excel and Outlook. Interpersonal communication skills and encounter working in a team environment are skills needed for this job place. Strong organization and prioritization skills are also beneficial skills that companies may need applicants to possess for the scientific analysis manager place.

Supervisory Role

Many scientific analysis experts become promoted or advance to the higher level supervisory positions after gaining additional qualifications and expertise in scientific analysis. Clinical analysis planners oversee the entire process of scientific analysis investigation and tests and ensure that all medical experiments and tests are compliant with the objectives of each project. Clinical research management is a wonderful field and you can choose to make your 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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What Are the Steps Related to Clinical Assessments?

Clinical assessments are a type of analysis that involve huge numbers of individuals order to test new therapies. Many, but not all analysis, are assessments.

Clinical analysis aim to find out important info in response to any adverse wellness question in a very methodical way. A well designed analysis will provide efficient evidence that can help improve NHS services and therapies and the healthcare understanding of doctors.

To be efficient it usually involves obtaining wellness details from a variety of individuals whose healthcare concerns fit the topic of the study. Where sufferers agree, or “consent”, to join as volunteers, this details might be obtained by:

  • Interviews
  • Questionnaires
  • Tests on sufferers in a healthcare setting that measure the effects of new drugs
  • Using individual records
  • A combination of the above

If you are interested in becoming a individual in research:

You could ask your GP or Advisor to consider any assessments or analysis that you may be suitable for You could check out the web pages for your local Clinical Research Network

You could check out the The UK Clinical Trials Entrance which provides details about scientific analysis assessments running in the UK

The NHS Structure says that your NHS healthcare professional should inform you of any analysis for which you may be eligible. ‘Eligible’ here concerns how you fit the strict healthcare and personal requirements used in the study design for it to work technically.

Think about it for a time that you are a effective psycho therapist. Cynthia comes to see you because she’s having a problem. How do you cure her? How do you even know incorrect with her?

Clinical assessment is a way of identifying and preparing treatment for a individual that includes analyzing someone in order to determine incorrect. There are several kinds of emotional tests, all of which have their own pros and cons.

What’s the point of assessment? To response that, let’s go back to the time that Cynthia walking into your workplace. She informs you that she’s sensation very pressured out and nervous because she keeps failing to remember factors. She used to be really up to the mark, but lately she has problems keeping in mind where she sitting her car or what she did just a couple of moments ago.

What’s incorrect with Cynthia? There are several factors that can cause forgetfulness. The only way that you can find out incorrect with her is to do some kind of assessment. Medical tests help you, the psycho therapist, to know what might be resulting in trouble for your individual. Clinical assessment example can be related to psychology.

Related Topics:

1)Requirement of Clinical Research Associate

2)What is the responsibility of a clinical research associate?

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Pain Management Trials With The Placebos

Pain Management Trials With The Placebos

Going by the definition of placebo, it is an inert substance that has no effect on our body. In clinical research, placebos such as sugar pills are used as controls against which the effects of experimental drugs are measured.

Even though the placebo-effect has become a well-recognized phenomenon. A phenomena in which a patient believes he is being administered an actual drug and gradually improves in spite of receiving no active substance.

It also works with surgical procedures. Just like drugs, placebo or sham surgery is shown to produce results that are equal to actual surgery, though the physical problem is not addressed.

Since years, we’ve known about the “placebo effect”—that a patient, simply by believing that a treatment is effective, might experience a beneficial effect from a clinically ineffectual treatment. Of course, it goes against the ethics. The ethics of deceiving patients into falsely believing that a placebo is an effective treatment is questionable—so clinical researchers have recently turned their attention towards open-label placebos.

Random Controlled Study:

OLP vs TAU Group

A recent Pain article documented a randomized controlled study of open-label placebo treatment for chronic lower back pain. 97 patients were divided into 2 groups: One continued treatment as convention (TAU), while the other group received open-label placebo pills (OLP). Before starting with the study, patients were told that the human body can automatically and powerfully respond to taking placebo pills—and all patients were aware of whether they were in the TAU or the OLP group.

At the completion of the study, patients in the OLP group showed significant decline in both pain and disability—in simple words, though they knew that they were on a placebo pill, the patients yet reported an improvement in their chronic lower back pain.

But what does that mean for central nervous system (CNS) clinical trials?

The Essence of Rater Training in Clinical Trials

In this study, the efficiency of the placebo pill can largely be chalked up to the nurturing approach of the rater and investigator, who repeatedly stressed the positive potential of the placebo effect. In CNS trials—especially when it comes to pain management—rater training is absolutely essential to avoid the increasing placebo response rate.

Solution: A Supportive Environment for Treatment

That’s why Clinical Trials employs a four-stage certification process for raters, validating their experience and knowledge and calibrating them to the standard scoring conventions and protocol specific study criteria at the beginning of each study. Raters require knowing that simply being in a therapeutic environment can heighten placebo effect—so a “research” atmosphere, rather than a “therapeutic” one, must be the goal. Interaction with site staff must be controlled, and not unintentionally create a non-specific supportive treatment environment. Staff also must know that they should have no expectations of drug response, either positive or negative, and should explain the same to the patients.

How Rater Training Can Benefit Pain Management Treatments?

To mention, the placebo effect is not a replacement for effective pain-management treatments. By properly training raters to be well aware of the placebo effect and assess each participant in CNS clinical trials, they can very effectively continue the search for treatments for low back pain, osteo-arthritic pain, neuropathic pain and other areas of CNS expertise.

We conclude the discussion here.

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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Top Hurdles For Patient Participation in Clinical Trials

Top Hurdles For Patient Participation in Clinical Trials

Today we dedicate our blog topic to the hurdles that is face during participation of patients as part of clinical research.

Huge amount of money and good amount of time is spent in enrolling patients and hence addressing the concern of the hurdles that is faced must be addressed to increase study chances and reduce failure rates.

So while designing your trial, keep these 4 barriers in mind as an attempt to prevent participant dropout and errors before they become a threat for the success of your trials:

1 Misconception:

To a patient, the clinical trial phases are full of unknowns. The patients should be detailed about the processes otherwise they might be concerned by fear of being a “guinea pig”, odds about placebo, loss of autonomy, or worries about unknown side effects.

Solution:

You need to address these concerns very early during interactions with the participant. Communicate well how each aspect of the trial is important. You should also mention the advantages of participation, like gaining access to expert medical care, knowing more about their condition, and being active players in their own health care.

2 Mistrust:

Try to understand that history saw mistrust in the medical field, mainly when dealing with minor populations.

Solution:

Be transparent with the patient about your actions and this would be helpful because it will identify and explain the study motives. Another way is that you break down if any communication barriers like language or technological literacy.

3 Logistics:

When developing and implementing a clinical trial, be practical with various aspects. In addition to achieve heights for your site staff, ensure to evaluate the trial design from the participant’s view point, like they must have a busy life and they must be considering your trial a priority in their lives. Common logistical hurdles include inability to take leave from work, transportation to and from the research site, how often they need to be present and how far they might need to travel. Whether they have kids or rely on caregivers, this factor can make things complicate in their participation.

Solution:

During the design of your trial, be mindful about what is needed of the participant. Know the barriers and try to address them as much as possible.

4 Costs:

In order to overcome logistical barriers, many patients will spend their own money to participate in a clinical trial. If your participants face delays in the payment process, they might be forced to wait for reimbursement for up to weeks at a time. With this prolonged and slow payment model, participants might be on their next trial visit before being paid for their last visit. This delay might leave the subject feeling undervalued or that the trial is not systematic, which could lead to decline in compliance and participation.

Solution:

As the participants need a variety of accommodations for logistical planning, they might also need a diverse payment options. Giving your subjects a choice on how they would like to be paid increases your site’s dedication to patient’s concern, which increases the chances of a positive experience in clinical trial. Tools like Nimblify’s Participant Payments provide a variety of payment options that could not only decrease your site’s administrative burden, but also offers other effective and diverse payment plans for participants.

Reducing these barriers to participation in a clinical trial can lead to more reliable study data, make your site more patient-centric and provide an overall better participant experience you achieve future success.

We conclude now with this discussion.

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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Interview For Pharma Freshers : Tips & Preparations Part II

Interview For Pharma Freshers : Tips & Preparations Part II

Today we continue with the same topic we were discussing in our previous blog post.

Interview tips

The three aspects of the interview process:

  • Pre-Interview Planning
  • Interviewing
  • Following-up

PRE-INTERVIEW PLANNING

This will make you more confident and keep you motivated. Before you start keep a written or computerized list:

  • Date resume was sent
  • Name of company
  • Name of person you sent it to
  • Address
  • Phone
  • Date and time of interview
  • Results of interview
  • Second interview
  • When you sent a thank you letter or note

You need to find about the company thoroughly, which is very essential but it is often neglected. Try finding out the following information:

  • Products or services
  • Company history
  • Number of employees
  • Business methods
  • Distribution methods
  • Organizational structure
  • Clients or customers -Locations
  • Reputation
  • Philosophy
  • Industry standing/ Sales or activity volume
  • Prospects for company growth

INTERVIEWING

You need to relax and think about all of your skills, accomplishments, and abilities. You should know your strength and weakness. You need to make a resume that would say everything about in details and must be appealing.

Resume

  • Be honest.
  • You need to quantify your achievements with figures and percentages
  • You must think in terms of increasing productivity, decreasing costs, and increasing profit for the company.
  • Try to appear relaxed and alert
  • Be friendly and an enthusiast.
  • Always dress in your formals and be calm in your look.
  • First impressions counts.
  • Groom yourself well.
  • Sit comfortably and with good poise.
  • Ask questions. If you want to clarity certain aspects of the job.
  • Don;’t ask about paid holidays and vacations unless the job is offered
  • Carry extra resumes and references with you.
  • No fancy jewelry please.
  • Be polite.
  • Show a can-do and positive attitude.
  • If asked general questions, answer in terms of your professional abilities and experiences.
  • Never, never criticise former employers.
  • Have good posture and direct eye contact.
  • Give a firm handshake before and after the interview
  • Speak clearly in a firm, confident, and not too loud voice
  • Smile, when appropriate
  • Try to relax
  • Give specific answers to all questions. Don’t be vague.
  • Thanks the interviewer.
  • If you are really keen for the job, tell the interviewer again before you take your leave.

EMPLOYERS INDICATE THAT YOU CAN HURT YOUR CHANCES OF GETTTNG A JOB BY :

  • Poor career plans
  • Under qualified for the position
  • Communication not proper
  • Unsatisfactory evidences of achievement
  • Fail to research the company
  • Displaying a lack of interest in the organization
  • Unwillingness to relocate
  • Appearing more interested in money and benefits than anything else
  • Fail to follow-up post interview

THE GOLDEN RULE OF INTERVIEWING:

Be yourself, know yourself, and sell yourself.

Employers are looking for someone who can contribute to the buisiness by:

  1. Making Money
  2. Saving Money
  3. Saving Time

So keep it in mind.

WE conclude the discussion now. You have to prepare by your own and crack your interview confidently.The above tips are very essential to keep in mind. Good luck!

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 improving yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will help and guide you in making 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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Clinical Research For Physiotherapy

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

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

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

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

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

A few to mention!

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

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

Physiotherapy treatment might involve exercise to improve strength,

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

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

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

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

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

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

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

Related Posts:

1) Clinical Research Organization

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

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A Drought in Antibiotic Discovery

A Drought in Antibiotic Discovery

The year 1928 saw a major medical breakthrough owing to Flemming’s serendipitous discovery of penicillin, which was later claimed as the 20th century miracle drug. But the impact of this discovery was not well understood until the 1940s, when its application as a therapeutic agent was made possible by Florey and Chain.

Blamed for this late realization was the lack of biochemical and microbiological expertise at that time, as well as the lack of interest and support from the scientific community brought about by previous experience with the failure of pyocyanase and the toxicity of Salvarsan.

A-Drought-in-Antibiotic-Discovery

In 1935, a breakthrough that covered the era of antibacterials was made by the German biochemist Gerhard Domagk at the Bayer Laboratories of the I.G. Farben company in Germany. He discovered and developed the first sulfonamide, a synthetic red dye popularly known by its trade name of Prontosil, the first commercially available antibacterial.

The clinical successes resulted in a sharp decline in mortality due to killer diseases such as meningitis, child bed fever and pneumonia. Domagk’s discovery saved many lives, including prominent figures such as Winston Churchill and Franklin D. Roosevelt, Jr., son of then US President Roosevelt.

Inspired by the groundbreaking work of Domagk and Fleming, Florey and Chain, a number of subsequent antimicrobial discoveries quickly followed. Nowadays, newer antimicrobial compounds continue to be discovered and introduced, although the rate has slowed considerably.

According to an analysis done by a known magazine, large pharma companies spend approximately $5 billion to bring one new drug to market. About $350 million of the cost is to bring the drug to market, the rest is the money spent on drugs that fail safety or efficacy clinical trials, thus a pharma company must recoup the billions that they lose on failed drugs by the one drug that makes it to market.

A lot of money spent and pharmaceutical companies recoup more of their money on drugs like antidepressants and anti-inflammatories because they can be used regularly and not lose their effectiveness. That is not the case with antibiotics.

Antibiotics are very costly to develop and they can lose their power to fight infections with time. How? The bacterium that survived and is antibiotic-resistant is the one that begins reproducing in the body, thus the antibiotic originally used is no longer effective and a new antibiotic is needed to fight the mutated bacteria.

In the past five years the FDA has approved two systemic antibiotics. This is a drop of 88% since the mid-1980s.

While the benefits of the GAIN act are great, it seems that there is still a steady decline of new antibiotic development that has worried many institutions and organizations such as the World Health Organization (WHO) which stated that we’re in a competition against time to develop new antibacterials.

The small biotechnology companies are bringing new antibiotics to the market and it appears that the Center for Disease Control is pushing hospitals to enact antibiotic stewardship programs to make sure that such medicines are only used when they are really required. Dr. Tom Frieden of the CDC stated that antibiotic prescription can save patients’ from deadly infections and protect lifesaving remedies for tomorrow’s patients.”

Clinical research jobs are increasing and to meet the increasing need of efficient professionals , you should consider excelling yourself with training in Clinical Research

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

Related Topics:

1) Pharmacovigilance: Common terms used in drug safety

2) Pharmacovigilance scope

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Clinical Research and Scandals

News about mortalities are rare during a clinical trial, mainly during the initial stages. But in January 2016, six men in France who had enlisted in a phase I trial of a pain relief drug suffered brain damage. One man succumbed.

The report was sidelined saying a coincident.

According to the FDA, there were no clinical trials of the drug in the United States, That does not mean, however, that the U.S. industry won’t feel blow back from the incident that happened thousands of miles away. Indeed, learning from past experiences, the scandal could prompt the FDA to tighten regulations.

In the meantime, FDA regulators began working with their French counterparts in the Agence Francaise De Sécurité du Médicament et des Produits de Santé to apprehend what happened to the six men who signed up to test the drug, goes by the name BIA 10-2474.

A History of Scandals

The last major phase I clinical trial catastrophe in Europe occurred a decade ago in London when six men suffered permanent organ damage, and the loss of fingers, sue to some severe immune reactions during the testing of an arthritis and cancer drug,as per reports.

The main reason of a clinical trial is to give proof to authorities that a drug is safe and effective when used as recommended. Fact is that, many experimental drugs never make a pass through the first stage despite years of testing.

Gagnon said that the French equivalent, the Agence Francaise De Sécurité du Médicament et des Produits de Santé, abbreviated as ANSM, is a very genuine and sophisticated regulatory body. French clinical research organizations have to follow the country’s domestic rules and regulation programs as well as international and European Union regulations. Gagnon added that France and other EU countries are no different from the United States in requiring organizations to conduct proper clinical researches that will be safe for participants. The FDA basically conducts more inspections of sites, manufacturing facilities, labs and companies, mainly because FDA regulators have more resources to do so.

One of the most infamous scandals happened half a century ago and involved a sedative, thalidomide, which caused severe malformations among babies whose mothers took the drug to do away with morning sickness.

Thalidomide, yielded by a West German company and marketed in 46 countries, never made it to U.S. consumers. Frances Kelsey, a FDA drug reviewer said that in next to no time the fighting over the new drug laws that had been going on for five or six years suddenly melted away.

That scandal added another dimension to the review process, according to an account by FDA historian Suzanne White Junod. After thalidomide, drug manufacturers not only had to prove that a drug was safe, they also had to show “substantial evidence” that the drug was effective based on “adequate and well-controlled studies.”

Balancing Risk and Rigor

Today the scale of approval of new therapies has become very high. The FDA holds patient safety as foremost in their review decisions,which helps pharmaceutical and medical device companies meet safety regulations.

In the race of many institutes CRB Tech Solutions has created a niche. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly and to meet the emerging need of efficient professionals , you should consider upgrading with clinical courses.

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

Related Posts:

1) Clinical Research training in CRB Tech

2) Clinical research training course in CRB Tech

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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.

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2. Top 10 Clinical Research Interview Questions

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