Monthly Archives: December 2016

A Great Time For A Biostatistician Job In Pharma Sector

Those who want to work in statistics within pharma sector could be an excellent career move for several reasons. The role of statisticians is increasingly becoming vital within the bio industry, and with increased dependency on biometric data by pharma companies, need for biostatisticians are on the rise.

In this article we share our advice for anyone who’s looking to apply for the role of statistician in pharma jobs

A recent study by PayScale and MONEY discovered that Statistical Analysis System (SAS) skills came top in a list of the most in-demand skills for employers. And like many other sectors, life sciences are finding the role of statisticians to be very important. The amount of biometric data that’s collected in clinical trials is growing with time, and with an increase in the role of digital health technology, this trend is to continue.  

Many of you desperately want a career that gives the feel as if you are making a difference. Job profile as a statistician or biostatistician job within the bio sector, mainly pharma, enables you to do this.

The top 10 pharmaceutical companies, like GlaxoSmithKline and Gilead, are dedicated to developing safe and effective treatments for the world’s most critical diseases. With analysis of data from clinical trials you will be contributing directly into this important research, helping to make the way towards medical inventions that could help thousands of lives. 

Biostatistics Job Description

As a biostatistician or statistician, there are several similar job responsibilities:

  • To develop plans for statistical analysis
  • To write statistical methodologies
  • To write the results section of reports
  • To prepare and deliver training to internal staff and clients
  • Offer statistical support to clinical or manufacturing processes.
  • Advise on SOPs from a statistical point of view

Biostatistics jobs within pharma focus mainly on assessing clinical trial data. This could be during any of the phases of a clinical process and would analyse a range of data from age to adverse reactions. Some might be responsible for supervising the methodology of experiments or even designing the experiment plans. Many biostatisticians are need to specialise in a particular therapeutic area, like oncology or HIV, or a phase, like phase III or preclinical.

Training and qualifications needed

As a minimum, to qualify as both statistician and biostatistician, you need to have a bachelor’s degree in statistics or a mathematics based subject. Related degrees could include biology, toxicology, microbiology and geoscience. Experience in statistical programs like CDISC, Statistical Analysis System (SAS), and SDTM also, having strong knowledge of standard operating procedures (SOPs) and statistical principles, will be essential for your day-to-day activities.

How To Become A Pharmaceutical Statistician

If you don’t have a regular degree in biostatistics, and you are going from a non-pharma statistics job straight into a biostatistician role, this might be tricky. Having a higher level of education, especially in a science subject, is an essential attribute in this field.

How does the career progress look like?

Career height has a clear structure but mostly depends on the company you are working for. On a whole, the levels are statistician, senior statistician and principle statisticians, with roughly 4 years’ experience required to progress between each stage. As a principle statistician, you can lead projects and the role will be a lot more of client-facing. After this, you can look to move forward into a manager, director, associate director or even the head of biostatistics in Pharmaceutical industry. Pharmaceutical statistician salary is also very alluring.

The essential features required are pretty good communication skill, work independently and adapt to changes. These will help you stand you in good stead for a successful career as a biostatistician within the pharmaceutical sector.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections 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 requirement of efficient 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.

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

Guidelines to Enhance Pharmacovigilance (PV) Market Pharmacovigilance

It is the study of long and short terms effects of medicines on individuals. Though pharmacological science existed in the medicine sector since a long time, it has now taken a new trend. Today, this science gained popularity among young generations and students are looking forward to make a career in Pharmacovigilance.

PG Diploma in Pharmacovigilance is an important part of the healthcare sector and is necessary to improve the accuracy of a medicine. Assessing the risks by the drug reactions and monitoring the fatal same to the consumers is the main purpose of the pharmacovigilance industry. The rising awareness about the importance of this process is leading to a sudden increase in the global Pharmacovigilance (PV) market. Pharmacovigilance is a steady process and depends on its continuity to produce progressively more reliable results.

Job Responsibilities

It is essential that before you begin a course in Pharmacovigilance, to have a basic understanding of the job responsibilities. While working in the sector of Pharmacovigilance the job responsibilities to be fulfilled include:

You should know the basic knowledge of different kinds of steps that are involved in drug production. It is a multi step process it happens only after completion of a series of steps. This is why it is necessary to have the requisite knowledge of all the steps.

Hazards Due to Drug Consumption: Consumers must not have the knowledge about the hazards, it becomes the responsibility of a medical professional to evaluate the problems that might arise after consuming a particular drug.
• Protect the Patients: The medical professionals find out the possible effects and also needs to figure out a solution to protect patients against them.
• Conducting Research & Surveys: The healthcare sector is constantly evolving, hence given rise to the development of clinical research sector as well.

Careers in Pharmacovigilance (PV)

When you complete a course in Pharmacovigilance, you might find many different roles and job titles.

Some of the main areas include medical writing, quality assurance and medical affairs; but these positions require increased responsibility and much experience.

As a candidate, there are many job opportunities abroad in drug safety. These positions are found in large companies.

When you complete a course in Pharmacovigilance the yearly income can vary a lot, but earnings usually falls in ranges between of £25,000 – £60,000 per annum. This also depends greatly on factors like experience, the regulatory body, location and role and responsibility.

Types of jobs in the pharmaceutical industry

Drug safety officers are responsible for keeping a track and observing reactions and effects during drug trials and studies. A report on the clinical study is submitted to regulatory authorities, and once the report has been submitted drug safety managers should review and organise the reports to supervise the profile of specific medication products.

Drug safety physicians attain as well as evaluate information about the safety of the new products. They also need to carry out medical case reviews and assess the product safety during clinical trials.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections 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.

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

Applied Clinical Trials

Today in this blog topic we shall discuss in short the roles of technology in clinical research industry or fields.

It is quite noticeable the vast array of technological solutions that is bringing lots of changes to the clinical trials process. From a growing body of literature to webinars to multi-day conferences, it is clear that technology is key to a world focused on making great improvements such as rapid study start-up, streamlining transmission of clinical trial data, and supervising how studies are carried out.

Why now?

The advent of cloud-based capability could not come at a better time. It coincides from the FDA to adopt technology, as evidenced by the release of two guidance and one draft guidance on this subject.

New solutions

With the cloud gaining popularity, so, too, are the technologies it supports, such as eTMF, eSource, RBM and advanced-generation clinical analytic interfaces built on virtual, on-demand data warehouses. A brief review of these technologies says how they are essential to helping move forward the clinical trials.

Electronic trial master file (eTMF)

The eTMF refers to the electronic version of the important documentation required to conduct a clinical trial and assess the quality of the data produced. Initially, when the TMF went electronic, it was generally maintained on an in-house client server and worked mostly as an electronic file cabinet whereby paper documents were scanned and archived, but was significantly static. Over the time, this format matured to a cloud-based solution that has massive amounts of interactive data that could be used for strategic planning of an ongoing trial. To mention, the eTMF provides greater visibility of data among stakeholders, documents are always ready for audit, and there is working as a business planner tool, without need to maintain the IT infrastructure in-house. 

eSource

Another solution, eSource, is gaining rapidly, especially since September 2013 release of the FDA guidance on the subject, which encourages its utility. The guidance says. eSource is defined as data initially recorded in electronic format. Data taken during a study visit can be entered directly into an electronic case report form that is called eCRF, a process that has the advantage of lowering errors by removing the step of first writing on paper and then transcription.

eSource addresses one of the major issues of EDC: the need to transcribe document sources into CRFs.  With eSource, clinical information flows directly into the study’s clinical trial database in near real time or real time, permitting for earlier notice and a rapid start to data analysis. 

Risk-based monitoring (RBM)

RBM uses targeted approaches to remote or cloud-based supervising of subsets of the clinical trial data, and can take the form of statistical risk-based algorithms and partial SDV based on fixed risks tied to the protocol. TransCelerate BioPharma, a non-profit focused on innovation in R&D, has provided further clarification into RBM through its position paper on the subject. It explains 5 steps, starting with risk evaluation, and ending with looking after execution. As a part of this effort, TransCelerate makes frequent references to use of technology for central or off-site monitoring to make the wished efficiency profits without affecting patient safety. The intentions are to reserve onsite monitoring to further support patient safety, site process, and data quality.

Technology driving changes

With the use of the described cloud-based technologies, a change in the current business model is needed. Current model was developed decades ago, in response to a time when clinical trials were very different from today’s global multi-site approach. Even the introduction of EDC, which brought huge strides in terms of edit checks, a better query process, and rapid viewing of clinical trial data, was still rooted in the conventional business models with legacy approaches to supervision and validation. By comparison, other data-heavy industries have changed their business models, and research suggests similar changes in the clinical trials sector.

Not surprisingly, the industry is in different stages of adoption, reflecting different sizes of companies and levels of sophistication among stakeholders.RBM is a technology that helps to make many transitions. An industry expert, Whitaker appreciates and welcomes the changes offered by technology, but feels that, at least to some degree, the human touch is getting lost. She said her site is starting to notice that streamlined processes and technologies are shortening the research phase by getting the data collated and meeting contracted timelines, but we the human element with RBM is getting lost. The monitor can see the clinical trial data remotely, but they aren’t seeing documentation of the informed consent process or the actual signature of the investigator on various documents. Whitaker added that they aren’t seeing any notations, like why the patient was out of window or why certain factors were not reportable to an IRB.  

We conclude the discussion here. Hope you liked it and let us know what else could be the advantages of technology in the field of clinical research trials.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections 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

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

How To Make A Pharmacovigilance career

Pharmacovigilance (PV) or drug safety is a vital aspect while assessing the risk/benefit of pharma products and confirming that they are safe for patients. But, career opportunities in this field are often difficult, particularly for those who are not doctors. Here we share some tips to help you in your pharmacovigilance career .
How To Make A Pharmacovigilance career

With an exception of drug safety doctors, most pharmacovigilance professionals begin their career in a case processing role, such as a drug safety associate or pharmacovigilance officer. Risk management roles are senior positions that exist to identify and assess the health risks of pharma drugs that are identified by the case processing and signal detection teams.

What are the career hurdles?

Unlike many other pharma jobs, in which the larger organisations can offer the greatest opportunities for progression and training, one of the main obstacles to gaining experience can be that large pharma companies often have their case processing teams located on different sites, which are commonly in different countries to the technical teams. Employees who work in these isolated departments will gain very little, if any, technical exposure or contact with the more senior detection and risk management staff, who are likely to be based at the company’s global headquarters.  

Tips for advancement in career in technical roles

If you are beginning your career in pharmacovigiance and your career goals are to work in risk management, the type of company that you start your career with can have a big impact on your ability to progress further down the line. If you do find yourself in a job with few opportunities, it might be time for you to consider moving to another company that will enable you to gain the necessary skills and experience that you will need to progress. This might seem like a sideways move at first, but in the long term it will open greater opportunities for you.

Working in the role of case processing in PV at the following types of companies will offer the greatest prospects for development:

  • Small pharma companies: They have limited resources, and with smaller processing teams often you can become involved in a variety of tasks within their daily jobs. This often provides opportunities for team members to work more closely with signal detection and risk management staff, while taking on some of their responsibilities under guidance.
  • Sites with global activities: Working at a business where the processing roles are done at head office or regional headquarters gives you a far greater opportunity to work alongside and learn from your technical peers than working at a place where the role is performed in a different location.
  • Generics businesses: AS generics can be created after the original manufacturers patent has expired, therapies made by generics companies comes to the market for many years and all safety issues are known.
  • Regulatory and drug safety organisations: Many pharma companies outsource their signal detection to service providers, who specialise in this sector. These drug safety consultancies have loads of work from various companies, which make them great places to work for and learn new things. They are good companies for career development, training programs for case processors in signal detection.  

Becoming a line manager

For people who are wants to take career in line management than developing their technical skills, competition among peers is the biggest barrier. Depending on the team size, company politics and your natural capability to stand out as a leader, decides everything.

Example careers

Below are examples of some of the candidates how they climed in their career path:

Candidate A

They started their career in case processing as a PV officer. Their next career move was for a an authority as a scientific assessor where they were trained in signal detection and risk management. After sufficient experiences they were able to get a signal detection and risk role at a large global pharma company.

Candidate B

They began their pharma career as a pharmacist. Then they spent 6 years working at a small biopharma company where they gained knowledge on risk management responsibilities. They now works in one of the world’s largest pharma companies as a senior risk manager.

Candidate C

They got their first drug safety job doing case processing and quality checking of case processing at a global generics company, and after a year they were promoted into the signal detection and risk team. After 2 years, they landed into senior signal detection and risk role at top pharma companies.

Candidate D

They completed PhD, and then joined a large CRO as a case processor. They gained successive promotions over a number of years and worked their way up to a line management position within the company. 

We conclude the discussion here.

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

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

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

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

5 Red flags That Your CRO Is Setting Your Clinical Trial At Risk

Today’s article is about the problem that you might face owing to the choice of CRO in clinical trial you made. It’s a lengthy process till you get the CRO carrying out your research but if you make a wrong choice or if they commit some mistakes.Imagine a contract has been signed and the study began, but things are not going as they were expected!

Here we enlist are five red flags to watch out if you have any problems with your CRO, as well as we mentioned tips to overcome that crisis.

Team members don’t response in time
It’s not expected that your team will sit at their desks whole day to answer every phone and check their emails. As they need to be working on your project. So what could be a reasonable amount of time to wait for a response? Hopefully, some clear expectations for response times should be set up during the project management plans. There should also be a process and expectations to deal with time crucial issues.

You were not shown important study documents.
The CRo drafts a variety of documents during study start-up. You must be given a chance to give input, review, and sign off these documents as they will direct for the execution of the study and ensure expectations are set on all sides.

Not receiving regular status reports.
Status report is another crucial topic your project team should have covered at the kick-off meeting and in study documents such that you know what to expect in each area for which the CRO has taked responsibility. They must be sending you status reports consistently in a format on regular basis. The reports must include detail enough that you can track the progress of important activities and look after any significant risks to the study.

Signs that data isn’t being managed properly.
In a study, you gave to see the following in terms of data collection and management:

    • Data is collected in a device designed to handle clinical trial data. If data is collected in spreadsheets, this is a very significant problem. This might seem obvious, often studies are rescued where data was collected into Excel spreadsheets.
    • You are given a chance to participate in User Acceptance Testing if your study is using EDC. This is the best way to familiarize yourself with the specifics and also depicts transparency on the part of the CRO.
    • Queries are sent and closed regularly.

At times, despite best efforts, you might decide that you need to change CROs mid-stream.  Here we enlist some tips for interacting with your existing CRO before and during the transition as well as tips for selecting a CRO to rescue your study:

  • Keep copies of all documents (study plans, annotated CRF, build specifications, decision logs, etc.) in case you need to transit the trial to another CRO.
  • Get regular data transfers.
  • Request and use a communication plan and learn how to escalate issues if required.
  • take regular meetings with the team members to keep everyone on the same page. If possible, in the meetings include both members of the CRO team and the rescue team make the transition smoother.
  • Negotiate the financial aspect of transitions such that the incumbent CRO can work fast to complete tasks instead of relying on the new CRO to complete them all. Tips for Selecting a CRO for the Rescue

They must have a thoroughly maintained rescue project plan template or process.

  • They’ve successfully done rescues between the applicable platforms.
  • They realize the need to minimize and manage process change for clinical trial sites.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections below.

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

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.

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

Clinical Research Careers In India

In this article we shall be discussing the career prospects for Clinical Research Careers in India. Clinical research is a booming industry for researchers in worldwide and is the same for India.

Clinical Research Careers In India

Clinical sector sees tremendous growth and job opportunities not only for trained professionals, but also for management people, regulatory authorities, government and the entire society as a whole. With the increasing flow of multinational sponsors in Indian clinical research, the industry is expected to grow exponentially and open up new avenues for employment.

Those looking forward for a clinical research career , you could find yourself working in challenging roles depending on the types of clinical research being conducted. We list a few of the avenues below:

  • Contract Research Organizations (CRO)
  • Pharma Industries
  • Biotech Companies
  • Medical Writing 
  • Pharmacovigilance 
  • Patient Recruitment Organisations (PRO)
  • Clinical Data Management
  • Regulatory Affairs 
  • Logistics Services
  • Research labs
  • Clinical Trial Audits

Options for research careers

Every clinical study needs a principal investigator to lead the study. These investigators could be any of the following: researchers, medical practitioners, professors and scientists. Besides them, clinical trial studies need a vast array of professionals with various roles as mentioned below:

  • Clinical Research Associate (CRA)
  • Clinical Research Managers (CRM)
  • Clinical Research Coordinator
  • Clinical Data Manager
  • Biostatisticians
  • Research Nurse
  • Research site manager
  • Counsellors
  • Research Auditors
  • Pharmacovigilance Manager
  • Quality Assurance specialists
  • Project Manager
  • Marketing Executives
  • Contract Managers
  • Regulatory Affairs Manager
  • Lab staff
  • Translators 

To mention that career opportunities is based on academic qualification of the individuals.

Some common career paths for clinical research in India  are given below:

Doctors – They could get an appointment as Principal Investigator, Medical Advisor, Co-Investigator, Drug Developers and Regulatory Affairs Manager.

Life Science graduates, Pharmacists, Science postgraduates in Biochemistry – They could get appointed as CRA , Medical writers, Site Coordinators, CRMs, Biostatistician, Drug Development Associate, and Quality assurance

Management Graduates – They might find themselves working as a part of clinical trials in the roles of Business Developers, Managers, CRMs, or Regulatory Affair Managers.

Nursing graduates – They can fetch the role of research nurses or as trial managers.

Last but not the least, IT professionals, Engineers, PG in Maths, or Applied Maths, Statisticians can find job for the openings of Clinical Data Manager and Drug Development Associate.

There are immense growth opportunities along the path for the learners. And for those interested in serious research work, a PhD certificate can be a good solution.

Total worth of the industry in India currently

The global clinical research sector is worth above US $52 billion. In India clinical research industry has grew around the world at a relatively unparalleled rate in the past few years. It has created new avenues of employment for a large number of people. 

Often people get confused and ask” what is a Clinical Research Associate?” CRA are the backbone to any clinical trials. They have multitude of roles from the beginning to the end, in fact the entire flow from requirement gathering to the release of drugs to the market are all done in association with a CRA. Owing to its multiple job responsibilities, CRB Tech Solutions offer clinical research associate training and help you successfully secure a clinical research associate job.

What are some good universities that offer training in clinical research? Any NGO’s offering training related courses or resources?

Clinical research degrees, master’s courses and diplomas are offered by many institutions, which are way costly. However, there are also some grants and scholarships available for candidates from low and middle income households. There is also distance learning option, but has not yet become an official discipline with Indian universities. 

There could be other other training options that your employer might cover. We at CRB Tech Solutions offer clinical research courses with 100 % placements and our course material could help you stay ahead of your peers during interviews and in the work competitions.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections below.

In the competition of many organizations CRB Tech Solutions earned a good name. It has become one of the best clinical research institutes in Pune, Maharashtra.

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.

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

First in Human (FIH) Clinical Trials

First in Human (FIH) Clinical Trials

First this first, you must know what FIH is as all FIH trials are not the same. FIH trials are basically conducted with 20-80 study volunteers. The objective is to find the metabolism and pharmacologic action of a test drug in humans, the side effects that might be associated with increasing doses, and if possible gain early evidence on effectiveness.

In simple terms, FIH studies give researchers a base to understand the safety of the drug and might also show the action mechanism in humans.

Not an easy job

Nothing is so easy, there is Phase I studies that deviate from the FIH Phase I cookie-cutter norm, such as:

  • Clinical trials in which volunteers receive one of the following types of test drugs:
    1. A new compound in a novel drug class

    2. A novel compound in a drug class that is being through human testing with a different IND

    3. A novel drug/approved drug combo

    4. An approved drug with a novel formulation or changed dose

  • Clinical research requires a special population of age or type.
  • Clinical trials for which the drug is therapeutic

Each FIH trial should be evaluated on an individual basis because the objectives and risk factors vary. The preclinical data, trial design, proposed population, and safety measures must be evaluated for every FIH trial.

What part does the CRO play?

The CRO plays a vital role. They are to offer their expertise to make sure the successful completion of the clinical trial.  

CROs experienced in the conduct of FIH studies are knowledgeable and equipped to guide sponsors through the process of designing the best possible protocol. They conduct studies for the whole day, starting from Monday to Sunday. They would tell you about recruitment, if your blood draw times are feasible, and if your timelines are realistic.

A team with general or late phase clinical research expertise is not sufficient.

It is essential that the Chief Investigator and the study team have a lot of experience conducting FIH trials and possess the qualifications to make sure that the trials go smoothly. The clinical team is vital in ensuring that the protocol is optimal with little scope for amendments or deviation, while also making sure recruitment goals can be met, even with the most strict inclusion/exclusion criteria. Whether it’s a simple Single Ascending Dose (SAD) trial or a complex, adaptive design, the team conducting the study is a pivotal factor to success.

When it’s time to outsource a clinical trial to a CRO, it’s best to find out how involved the principal investigator (PI) and sub-investigators will be. Moreover, the experience of project managers, study coordinators, lab personnel, data managers, and medical writers are equally important. The PI is responsible for supervising the staff; however, problems can arise when a PI is either an inexperienced or uninformed in conducting FIH trials or puts too much responsibility on the staff to perform tasks that the PI should be overseeing.

In short, an experienced CRO can minimize the risk of recruitment and retention issues look after the safety concerns, bad data and a whole list of other issues that could halt your FIH clinical trial.

Does your CRO have what it takes?

You need to look into the matters discussed above and have your words with your consultant to know hoe efficient your CRO is.

We conclude the discussion here.

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

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

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

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

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.

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

How To become A Clinical Research Scientist?

How To become A Clinical Research Scientist?

Clinical Research Review presents the road map to become a clinical research scientist. This would help those who wants to make a career in clinical research.

Clinical research scientists does medical research for the welfare of health in humans and/or animals. Clinical research trials are one of their methods of investigation. Here is a chart giving an overview of how to enter this sector:

Degree MD &/or PhD degree
Field of Study MD: medicine
PhD: biology
Responsibilities Laboratory research & analysis for medical innovations; publication of research

Basic Education For A Clinical Research Scientist

There are various educational paths to become a clinical research scientist. Many clinical researchers have medical degrees, doctorates in a natural science or both. One can begin the pursuit of this career with a regular bachelor’s degree. A course of study in or related to the field of life science is highly recommended. The coursework in this area should include general biology, mathematics, physics and more specialized topics such as cell biology. Medical and doctoral programs are highly selective, so a strong academic record is desirable.

An Advanced Degree Program in Science or Medicine

Most clinical research scientist positions require either an advanced degree in the biological sciences or a medical degree. Graduate degree programs in cellular and molecular biology, neuroscience, biochemistry or microbiology often satisfy this need. Some universities offer master’s degree programs in clinical research. Alternatively, obtaining a Medical Doctor (M.D.) or nursing degree may qualify individuals to work in the field.

The success tips is that consider attaining a dual degree. Many clinical research scientists choose to complete a dual degree program with majors in science and medicine. In fact, some job postings require that candidates possess dual degrees. Students in these dual degree programs learn about medical practices and advanced research methodologies. Possessing two graduate degrees may make students eligible for more job positions after graduation.

Work as a Clinical Research Associate

The clinical research scientists typically begin their careers in fresher positions, possibly as a clinical research associate. These associates assist research scientists in designing and carrying clinical trials. They also help validate gathered data and monitor the procedures to assure that the process complies with professional protocol. The success tip is earn a certificate like the Certified Clinical Research Associate, Certified Clinical Research Coordinator and Physician Investigator. Earning any of these certifications requires clearing an exam. These certifications are recognized in the industry as indicating various job skills and, may help individuals advance in their careers.

Work as a Clinical Research Scientist

Clinical research scientists can work at universities, pharma companies, clinical research organizations, hospitals or for the government. These scientists perform analysis on cells, tissue and organs to identify microbes and toxins with the goal of understanding the reason of diseases and being able to develop vaccines or medicines for treatment. Some clinical research scientists may work directly with patients in health care centers by administering clinical trial drugs and therapies.

Research scientists have chances to advance to supervisory or lead positions with enough experience and strong performance.

The Success tip is to Participate in continuing education. Knowledge in scientific fields changes rapidly. Clinical research scientists may find it advantageous to participate in continuing education courses offered by professional organization. Such professional training may come in the form of conferences, webinars, online classes or in-person courses.

In the race of many institutes CRB Tech Solutions has it own name in offering Clinical Training.

Clinical Research review by CRB Solutions is enough to make you consider and take up 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