Monthly Archives: January 2017

Top 10 Reasons Why You Should Opt For Life Sciences Career

In today’s article we shall discuss the top 10 reasons why you should opt for life sciences career. Being a life science graduate and then wondering, what next will be answered here. Earning a career in recruitment within the life sciences sector could be one of the best career decisions you can make for the reasons you might not have considered.

Here we enlist the most significant reasons:

  1. A chance to create a difference

According to a leading tabloid, about 88% of employees admit that they don’t have passion for their work. The chance to work in recruitment allows an opportunity to pursue a more engaging and worthwhile career, one that leaves you feeling satisfied by the day end.

Working with pharma and biotech clients to recruit the finest talent is an excellent way to contribute to the development of novel drugs and treatments that will be beneficial for the mass. Every candidate placed at these leading, global businesses will bring them a step closer to giving the world with life-saving remedies.

  1.    Dealing with people who cares

Clients range from global pharma giants, innovative biotech companies and leading CROs.

Similarly, there will be placement of some of the best candidates in the industry into important, higher positions. These include medical director, clinical PMs and senior managers for regulatory affairs jobs.

  1.    An alternative to white coats and labs

Many studies revealed that, more often, graduates are likely to pursue a career that is not directly related to their degree.

In the life sciences industry, this might be because some do not wish to work in a lab or pharma settings and instead are better suited to a more people-facing career. On one hand, you will be use your degree on a daily basis, and on the other, you will be working in a dynamic, client-focused role.

  1.    A different take

Leading on from the previous point, several life sciences graduates might not fully understand how the pharma, biotech and other life sciences sectors operate. When it comes to choosing a career after they graduate, a lack of knowledge about what paths they can take may be very restrictive on their choices.

  1.    Apply your existing knowledge and experience

If you have spent time working within the life sciences industry and have decided you want a change, your existing knowledge and experience will give you a head start in the life science recruitment industry, and the direct experience would help you to build rapport more easily with candidates and clients alike. 

  1. Become a subject matter expert (SME)

Clients and candidates will expect a level of knowledge about the life science sector and the specific vertical that you specialise in.

  1.     Lots of opportunities for European speakers

As the majority of pharma, biotech and medical equipment companies operate globally, the demand for life science recruitment consultancies to employ those with language skills is quite high. This will need a recruitment consultant with the ability to collaborate with client representatives in other countries, and regional candidates to work on these international projects. Hence it is often beneficial for recruiters to be fluent in more than one language.

  1.    A better working environment

Owing to globalisation of clients and the need for multilingual colleagues, recruitment consultant jobs in life sciences will offer a dynamic and culturally diverse and challenging working atmosphere.

  1.    A good choice of industry

Beside the benefits of working in life sciences, it is wise to admit that the life sciences sector is stable and booming, and unlikely to be badly impacted by political events. The life sciences industry is not of luxury and will always be pretty invested, that affords good job security.

  1. ProClinical is hiring

Currently, they are hiring for life science consultants of all levels in various countries that include UK, USA and Singapore. They seek experienced recruiters from other sectors, but the internal recruiters opt for those without any experiences as they offer comprehensive development and training programme. 

Stay connected with us this space for more discussions.

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 fulfill 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.

Related Posts:

1)6 Ways ResearchKit Would Change Clinical Research

2)Top 10 Clinical Research Interview Questions

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Lack Of Data Integrity Would Render Them Meaningless

In this article “Lack of data integrity would render them meaningless” we shall discuss the significance of the importance of data integrity, without which any data could be worthless.

Data integrity is essential for the success of a clinical research. Without solid integrity, the data collected is worthless. Ensuring data integrity is essential for the research, as it is for the patients who will receive treatments based on the research.

The less defined standards used during data collection will help to make sure the data integrity. The data must be complete, reliable and processed in a consistent manner. Use of best practices during the data collection cycle will make sure the quality of the data. The risk is lowered when best practices are done at the start of a clinical process.

The data generated must be reliable. It must represent the purpose(s) for which it is being collected.

A key to quality management of the data is to ensure that the Case Report Forms(CRF)/eCRFs are well designed. A poorly drafted CRFs/eCRFs will lead to inadequate data collection and hence poor data integrity for the data collected because the necessary information might be missing or inadequate. Even as part of managing CRF data, it is important to make sure that the data entry is accurate.

Moreover, having solid edit checks programmed into an EDC or proprietary system, is to having clean, quality data. The edit checks will lead to inconsistencies in the data from many different ways, such as illogical data, missing data, discrepancies, and so forth. Manual checks, in addition to the programmed ones will also help the Data Manager in reconciling the data when programmed checks are not done.

Proper setup and assessment of the EDC system, plays a vital role in ensuring your data will have the required integrity required for acceptance by the FDA. The EDC should only be set up using a final version of the protocol. Using an incomplete version of the protocol will probably require the work to be resumed, which might be incorrect affect of how data is captured, which might lead to poor quality and compromised integrity of the data.

Data integrity must also be checked by revising the data in parts and then as a whole. Review of all data for a subject as a whole, say the patient profile, is an excellent way to maintain data integrity. It allows you to see inconsistencies across a subject and to correct that data before it becomes final.

One major area which might affect the integrity of your data is having mid changes during a study. Hence it is essential to avoid making system wide changes in middle of the study, unless it is the only solution. It’s wise to consider the possibility of changes when initially designing a study and avoid mid-study changes.

To conclude, there are many ways to maintain data integrity. It is your duty to make sure that the right steps are taken and documented that is needed for data integrity. The key is to think how you will manage this before the study start-up begins. You must be sure that you have well-documented processes and procedures. Integrity is easy to maintain with low risk, which is usually at the initial phase. Once the study has been initiated, reversing will be tedious and a lot more challenging.

Stay connected with us this space for more discussions.

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 fulfill 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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Upcoming Trends in Pharma Non-registration Trials

In today’s article we shall discuss on the emerging trends in pharma non-registration trials and their underlying deliverers. In the title: upcoming trends in pharma non-registration trials

Randomized controlled trials (RCTs) are assumed to be the gold standard in the hierarchy of research designs for assessing the efficacy and safety of a treatment. They are needed for drug registrations; RCT results have limited application for patients in everyday clinical care. Medical functions in the pharma sector are often tasked with non-registration trials to create further knowledge on treatment after registration trials. These studies aim to provide evidence because of their usage of diverse populations or long follow-up period.

To mention there are three trends in non-registration trials. The first trend is going pragmatic. GlaxoSmithKline’s Salford Lung study is the most pragmatic trial that was conducted in the pre-licensing phase. The trial examined the safety and effectiveness of a new treatment BreoEllipta for asthma and chronic obstructive pulmonary disease (COPD).

Now the question is why did GSK invest so much on a pragmatic trial? The profile of BreoEllipta might give a reason. The main benefit is improved adherence. The payers are unwilling to pay for just “once daily” or improved adherence. GSK needed to determine the superior effectiveness of BreoEllipta in a real world setting, and it is impossible to find that effectiveness in a double blinded, randomized trial. The other driver might be HTA bodies’ wish to see an effectiveness study and the value that it could bring. The study embraced heterogeneous patient population and was conducted in a lab setting. It also applied electronic health record systems to gather safety and effectiveness data.

A lesser talked about pragmatic trial is AstraZeneca’s DECIDE study, a pragmatic trial to evaluate the comparative effectiveness between Dapagliflozin and the standard of care in type 2 diabetes. AstraZeneca collaborated with Clinical Practice Research Datalink (CPRD) on this study. The effectiveness data on patients were collected via the CPRD network.

It is speculated that the pragmatic trial trend continues to grow due to several deliverers. The first is the increase in pressure to compare new therapies from payers. The second is less differentiating features of novel drugs. In addition, many pharma businesses are experimenting with various solutions. The impact of those solutions on the effectiveness can only be explained in pragmatic settings.  

The other new trends are seen in an area of observational research. Observational research in pharma is generally conducted as either a prospective study or a retrospective study, using patient-level data that are already present. However, as new advances in technology are changing the way patients is receiving care, old observational approaches don’t seem able to address the increasing complexity of research questions. In addition, more data points are now needed to understand heterogeneous diseases.

Trends are emerging now and really changing people’s perception of how observational studies could be conducted. One prominent trend is an approach to bridge prospective and retrospective design enabled by EHR systems. In this approach, while doing the primary data collection (prospective), EHR at study sites is utilized to gather patients’ historic clinical information and collect clinical data from their usual care. In addition, patients can be followed up beyond the prospective study period.

The second trend in observational research. This approach is required to understand heterogeneity in diseases or treatment responses. More and more observational studies are seen incorporating patient reported outcome data via mobile health (mHealth) apps, biosensor data via wearable, and even environmental data, e.g. weather, air pollutant, to understand the environmental impact. In addition, the inclusion of biomarker analyses from biosamples is also becoming very popular in observational research, to characterize chronic disease population and their response to treatment by disease mechanism.

A good example for the above two trends is AstraZeneca’s NOVELTY research study, a multinational, prospective, observational study of patients with a diagnosis or suspected diagnosis of COPD and/or asthma. In this research study, electronic health records from Nordic countries will be used to collect retrospective data of trial patients. Biomarker analyses will be carried out to further understand the phenotypes and endo-types of COPD and asthma patients. mHealth devices are also used for selected patients.

Stay connected with us this space for more discussions.

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 fulfill 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

Related Posts:

1)6 Ways ResearchKit Would Change Clinical Research

2)Top 10 Clinical Research Interview Questions

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Measures To Escalate Efforts And Prevent Drug-Related Deaths

There is increase raise of deaths caused by misuse of drugs. In order to take effective action you need better understanding of the various and complex concerns behind the disturbing trend. Here we shall discuss measures to escalate efforts and prevent drug-related deaths

Last year, in a national inquiry revealed a 17% increase in reported drug misuse deaths in England in the year 2014. This followed a 21% increase in 2013.

The inquiry led to an independent expert group report on what should be done to better understand the reasons of these increasing deaths and lower them in future years.

Data for 2015, published on the same date as the report, revealed an 8.5% increase in deaths due to drug misuse and told the need to immediately take up the recommendations of the expert groups.

It was also clear that those deaths occurred across various age groups, and from different kinds of drug.

They said they need to enhance efforts to make sure that the most vulnerable people can access drug treatment, and PHE continued to support local authorities in providing effective services to lower harm and promote recovery.

This article will speak about how the local areas can take action and the growing support available to them.

What is causing of rise in drug misuse deaths?

The sudden increase over the past three years is most likely due at least in parts to an increase in the availability and purity of heroin which followed a time where heroin purity was unusually low.

Heroin-related deaths have doubled since 2012 in England and Wales to the highest since records started 20 years back.

The ageing group who started taking heroin in the 1980s and 1990s are currently experiencing cumulative physical and mental health conditions that makes them susceptible to overdose.

And most of these long-term users are not taking any drug treatment where they can be protected.

But there are also other factors that might become more significant in the coming years, although their current contribution to such deaths is comparatively small. They include:

  • increased suicides by drug poisoning
  • a long-term trend of more deaths among women
  • an increase in number of deaths from other drugs which includes new psychoactive substances
  • increase in people using multiple drugs
  • an increase in prescription of medicines

Until a better help is done to both meet the needs of older heroin users and look up the factors that lead to increased numbers of deaths in increasing risk groups, all the evidence says that drug misuse deaths will continue to increase.

What should be done to bring down the rates?

It is speculated that drug misuse death rates would be even higher were it not for the implementation of evidence-based interventions already in place.

But there is yet much to do and maintain and escalate these efforts to lower these deaths and mitigate future rises.

Based on the evidence, the expert group recommended a number of actions for local providers, as well as other service providers.

These actions are all aligned with the following core principles:

  • to enable a whole-system approach to meet the various needs of drug users which includes better access to physical and mental healthcare, particularly for the old users
  • to maintain personalised and balanced approach to drug treatment and recovery support as suggested by national drug strategies and clinical guides
  • to maintain the option of evidence-based, high-quality drug treatment and other effective measures
  • to reach out to those who are not currently in the treatment system
  • to make sure that the risk of drug-related death is properly validated and understood, and eliminate poor practice that could increase risk

The group also emphasised the need for continued research and investigation to better understand the drug-related deaths and measures to prevent them.

Support available

At PHE, it was supported implementation of a new Public Health Outcomes Framework indicator that measures drug-related deaths in local areas to benchmark performance and encourages improvement.

Effort to provide service commissioners with more advice on provisions of naloxone, that has been found to decrease overdose-related mortality, and will be supporting the 2016 update to clinical guidelines for drug misuse and drug dependency.

The report from the national expert working group gives messages for key decision makers and local services that can help prevent future drug-related deaths.

PHE will be working both locally and nationally to support the cause and effort.

Stay connected with us this space for more discussions.

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

Related Posts:

1)6 Ways ResearchKit Would Change Clinical Research

2)Top 10 Clinical Research Interview Questions

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Light therapy Offers New Hope For Early Prostate Cancer Treatment

Today in this article we shall discuss in the title “Light therapy offers new hope for early prostrate cancer treatment” about a new cancer treatment. It is in news that a phase III clinical trial suggested that light therapy might be an effective and nonsurgical therapy for men with low-risk prostate cancer. It was found in the research study that almost half of the study participants with the disease went into total remission after going through a treatment with the novel technique.

Researchers are hopeful that VTP might be a promising treatment for localized prostate cancer.

In a study case of more than 400 men with localized prostate cancer, researchers said that the new treatment named vascular-targeted photodynamic therapy (VTP) is potential enough to kill prostate cancer cells, without any damage to the healthy surrounding tissues.

Moreover, VTP is found to reduce the need for radical therapy, like the surgical removal or irradiation of the entire prostate.

Lead scientific investigator Prof. Mark Emberton, dean of medical sciences and a consultant urologist at University College London in the UK, and his colleagues recently reported their findings in The Lancet Oncology.

After skin cancer, prostate cancer is the most common cancer occurring in men in the US, with about 180,890 new cases expected to have been diagnosed in 2016.

For men with localized prostate cancer it is considered low risk and did not spread beyond the prostate. Here the cancer is monitored through prostate-specific antigen (PSA) tests, prostate biopsies or digital rectal exams and it is treated only if it gets more severe.

If the cancer gets worse, treatment might involve radical prostatectomy that is surgical removal of the prostate and surrounding tissues or radiation therapy. To mention, these procedures could cause a number of side effects, which includes bowel issues, urinary problems, and erectile dysfunction.

Prof. Emberton et al suggested that VTP could lower the need for such treatments by fighting prostate cancer in early stages.

VTP was developed by researchers from the Weizmann Institute of Science in Isreal, in collaboration with biotechnology company STEBA Biotech.

The treatment involves injection of a light-sensitive drug called WST11, which is derived from bacteria found at the bottom of the ocean. The drug is administered into the bloodstream. On activation with a laser, the drug releases free radicals that destroy cancer cells in the prostate.

For the phase III trial, Prof. Emberton and his colleagues enrolled 413 men from 47 treatment sites across ten European countries. They were all diagnosed with early localized prostate cancer and were under active observation.

Among these patients, 206 randomly received VTP, while the remaining patients continued with active observation and comprised the control group.

Patients were kept under observation for 2 years, they underwent PSA testing and assessment of urinary and erectile functions for every 3 months, as well as prostate biopsies at 12 and a year.

After 2 years, the researchers found that 49 percent of patients treated with VTP had entered complete remission, in comparison to 13.5 percent of patients who received active surveillance.

Moreoevr, the researchers found that 6 percent of the men treated with VTP needed radical therapy, compared with 30 percent of men in the control group. The team also reported that VTP-treated patients were thrice less likely to have their cancer progress, and VTP was found to double the average time to progression from a year to two.

The researchers also reported that some men experienced urinary and erectile problems, but that resolved within 3 months of treatment. And at 2 years, no side effects were present.

The researchers reveal that the findings of their phase III trial indicates that VTP is a promising nonsurgical approach to the treatment of localized prostate cancer.

If the claims are very firm, then this is a huge leap forward for prostate cancer treatment, which previously was lagging decades behind other solid cancers like breast cancer.

Stay connected with us this space for more discussions.

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

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

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

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What is a case-control study in medical research?

In today’s article we shall discuss about case-control study in medical research. Well case control study is a type of medical research investigation which is often used to help determine the cause of a disease, mainly while investigating a disease outbreak or a rare condition.

If public health researchers want a very fast and easy way to find clues about the cause of, e.g. a new disease outbreak, they can compare two groups of people:

  • Those who already had the disease – “cases”
  • Similar people who are not affected – “controls.”

A case-control study is actually retrospective – the researchers look back at previous data collected which enables them to test if a particular outcome can be linked back to a suspected risk factor.

Prospective case-control studies are quite less known; these involve enlisting a specific cohort and following that cohort, with “cases” emerging as people who develop the disease or condition under investigation, and those unaffected forms the “control” group.

To test for a cause, the scientists must formulate a hypothesis about what they think might be behind the outbreak or disease, which are known as risk factors.

Then a comparison is made between how often the group of cases had been exposed to the risk factor, and how often the controls had been exposed. If the risk factor has a greater prevalence among the cases, then this is some proof which suggests that it is the cause of a disease.

Risk factors might be uncovered by researchers studying the medical and lifestyle histories of the people in every group. A pattern might emerge that links the condition under investigation to certain factors.

Case-control research is a main tool used by epidemiologists, researchers who look into the factors that affect the health and illness of populations.

Only one risk factor was investigated for a particular disease. A good example is to analyze how many people have lung cancer, while how many are without, but has a history of smoking.

Advantages of case-control studies in medical research

  1. Relatively quick and easy
  2. Does not need large numbers of people
  3. Overcomes ethical challenges

Limitations

  1. Recall bias

An illustrative example of recall bias is the difference between asking study participants to recall the weather at the time of the onset of a certain symptom, versus an analysis of scientifically measured weather patterns around the time of a formally recorded diagnosis.

Finding a biomarker of exposure to a risk factor is another way of reducing the subjectivity of case-control studies. For example, researchers may look at results of blood or urine tests for evidence of a specific drug, rather than asking a participant about drug use.

Causes and effect

Only since an association has been found between one thing and another, this does not necessarily suggests one thing is the cause for the other.

In fact, a retrospective study can never definitively prove that an association talks about a cause.

One way of illustrating cause-and-effect limitations is to consider an association found between a factor and a particular health outcome. The cultural factor itself says might not be the cause of the outcome if some other plausible common factor – a certain food preference, perhaps – is shared by the same cultural group of cases.

If researchers conduct a retrospective case-control study gets an association between depression and weight gain over time, for instance, they can’t say with certainty that depression is a risk factor for weight gain without controlling a sedentary lifestyle.

Sampling bias

The cases and controls taken for study might not be actually representative of the disease being looked after. An example of this is when cases are looked upon teaching hospital, which is a highly specialized setting compared with the community in which most cases of the disease might occur. The controls, too, might not be typical of the population

There are other disadvantages to case-control studies. While they are fine at studying rare conditions as they do not need many participants that prospective studies required; they are not very good at studying rare risk factors, which call for group studies.

Moreoevr case-control studies are not able to examine different levels or varieties of the disease being investigated. They can look at one outcome, since the definition of a case is set by specific diagnostic criteria against any straight question of whether, they had the condition, and they didn’t.

Other terms to substitute case-control studies include “epidemiological” and “observational.”

Stay connected with us this space for more discussions.

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

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

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

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What Clinical Operations Need to Know About Clinical Trial Supply

There are several clinical trial supplies and one of the mpst favourite one is BioClinica Optimizer as it can save tons of money and avoid problems in majority of the trials being run by optimizing the clinical supply. In today’s article we shall discuss mainly what clinical operations need to know about clinical trial supply.The interesting part about this clinical trial software is that most clinical research professionals does not even consider looking at optimizing the clinical supply. There are several reasons like the ones mentioned below:

  • They don’t understand that there is a guesswork present in determining the amount of clinical trial supply required.
  • The expanse for clinical trial supplies doesn’t come out of the clinical budget
  • Clinical and Data Operations personnel don’t know there are some tools that can optimize clinical supply
  • They thinks that the people managing clinical supply already have tools that manage it
  • They don’t want to question clinical trial supply plans because of the high risks involved

The tools that most business make use to manage clinical trial supply are typically spreadsheets. These are some complex spreadsheets that have been utilised over many years that try to predict how much supply will be required. These are mainly managed by one person who is responsible for determining how much supply is produced and how will it be distributed.

What we want to say here that the people making these decisions are guessing, and they are guessing very conventionally because they don’t want to be responsible for running out of study drug or a site that does not have drugs when required.

Lots Of Money Is Saved Through Optimizing the Clinical Supply

A recent discussion with a group of clinical trial supply optimizer product and informations gained were intrguing. They recently ran a study and asked a business to take those study parameters and find out how much supply was required. They also enquired us if they should package this in 4 week supply versus a 12 week ones. The study had 200 subjects enrolled in 4 treatment arms in 40 worldwide sites. It’s uncertain which study option was chosen.

On running the nymbers, it was found that the cost for the 4 week supply was $500. The cost for the 12 week supply was $1700. Even some assumptions around enrollment and shipping costs were done.

It was clear to all that the 4 week supply would cost lesser than the 12 week supply over the duration of the clinical process. Over the timespanof the study, packaging the 4 week supply would save $900,000.

This is mainly as the sites would have the initial 4 week supply required for any treatment set, but each category will be resupplied after the initial kit was dispensed. In order to have all 4 treatment groups available at all 40 sites previously, about 360 of each kit type for a 4 week supply would be sent out costing $720,000 compared to the same amount of kits for a twelve week supply costing $2.4M, a lot of extra supply was sent that would never be used. In simple words, if a site never enrolled a subject in a certain treatment group, 12 weeks of clinical trial supply will get wasted instead of 4.

Besides the factors mentioned, there are various other factors that affect the clinical trial supply cost.

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

Stay connected with us this space for more discussions.

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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Burn & Pain Management Clinical Research

Today in this article we shall talk about acute burn and pain management clinical research which is becoming an emerging model to solve challenges in burn and pain trial designs. We know that burns cause severe pain and burning sensation and very less trial have been consucted in this field.

Major developments have enhanced management of severe pain all over the globe. Emphasis on acute pain studies have shifted to outcomes which go beyond good pain relief towards lowering in the risk of developing chronic pain, critical medical conditions, and the development of psychological disturbances due to pain. Anyways, burn-associated pain represents one area where there is very less direction on the appropriate way and type of pain that patients experience. To overcome challenges in burn pain management research trials, there are various design-important issues that must be considered.

Understanding Variability of Burn Pain

In any trial model, neuroscience clinical researchers must consider the many attributes that affect the burn pain, including the phase of the wound and degree of the burn, the person, depth of the skin burnt, and the inflammatory response. A dynamic approach to burnt pain and trauma management is critical for a successful clinical outcome and must consider all of the above variables in targeting the various patient populations. To say that the pain is homogeneous among all patient phenotypes will lead to insufficient pain assessment, which barriers meaningful research and prevents optimal management of burn pain.

Human Pain Models

In the process of pain management studies, the selection of human pain models has many essential implications, and that permeates from early to late development. Most of the time, the main factor in selection of a pain model is what the indication will be at the end of the trial. Interestingly, a small number of proven models, such as osteoarthritis and diabetic neuropathy are typically chosen, hence limiting the development of new therapeutics for many other indications.

One approach could be to conduct trials with lesser studied models, like burn pain, which is very severe in case of deep and extensive burns, and mainly treated with standard analgesics such as opioids. This is clearly an area which would benefit from the development of new therapeutics, and although like every clinical trial model it has several challenges, it also presents itself as relatively straight forward, from the prospective of selection criteria. Clearly, the clinical trial faced on a daily basis is complex and burn pain management research is requiredto continue developing solutions to solve the clinical problems. To aid early analgesic development, human experimental pain models are receiving deserved attention and would inform later stages, including burn pain, more appropriately. 

To know more about Human Experimental Pain Models, check out various webinars available online. Several on-webinar are hosted by Worldwide on this topic. You could also learn more about Worldwide’s analgesia and pain experience by checking their sites, and read an elaborate article on burn pain trial design in their site.

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

Stay connected with us this space for more discussions.

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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Significance Of Data Queries For Better Data Quality

Today in this article, we shall discuss the significance of Data queries for better data quality. Recent findings from Medidata Trial Assurance portrays that the power of machine learning algorithms and their effect on pharma companies that seek greater capabilities to get quality data.

Trial Assurance is a service offered by Medidata’s team of former FDA statistical reviewers, who uses Medidata Centralized Statistical Analytics (CSA) technology to provide clinical trials analysis.The analyses are done by CSA’s unique machine learning algorithms, which ensures data quality so good, that’s largely unseen in drug development.   

When CSA is explained to potential clients, the immediate impression is that of a technology that can convert the way they manage and clear the data. They sees that CSA finds out data anomalies faster than manually and that it picks up on the types of issues that are nearly impossible to catch while using today’s processes. 

It is often found that CSA picks up on data issues that current data management and query processes have already captured,  yet these standard query processes don’t actually clear the data.  The conventional system is broken. Let’s look at two instances.

One of the major attributes of CSA is that users can get insight of all queries at patient level.  Hence it provides transparency into their eCRF data within Rave, to understand if the issue is new or an old one that they have already dealt with and was resolved.

In the first instance, CSA found that a value for one trial subject’s temperature reading (98) was higher than the other temperature readings in a study. 

Using CSA, the reviewer was able to view the queries for this subject and find that the data point had been queried for being out of range. But when looking at the query, the site responded that the value was correct, did not change the value, and the query was closed.  The data was not been changed when it was supposed to be. In this situation, the site entered the temperature value in fahrenheit when it should have been entered in celsius.

In a next instance, a CSA graph of respiration vital sign readings clearly shows that two data points are outliers in the data.  Both data points were from the same site, and both were queried.

But again the site did not change the value of the data points in response to the query. Instead, the site wrote a response: “Done Data.” What exactly does that say? And in this instance, the query was closed and there was no improvement to the data quality.

In both of the instances, the findings are straight.Conventional data management practices could often find these errors very easily.  The value of CSA is that it’s easy to see when a value is an outlier, and it’s easy to track the query history and the solution for each data variable. 

The purpose of the data management practices and the use of a tool such as CSA is to enhance the quality of clinical trial data. If standard practices doesn’t work to achieve a good outcome, then taking an novel approach like CSA can help you.

Trial Assurance allows Medidata’s FDA experts to conduct analysis directly in CSA.  Thus you can see the final results and recommendations that CSA will bring to any organization.

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

Stay connected with us this space for more discussions.

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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Tips For Healthcare Implementing Health Analytics

In healthcare sector, hospitals are increasingly focused on using predictive analytics to integrate and organise their services, but the question is how many organizations are successfully meeting this goal? Here in this article we shall discuss tips for healthcare implementing health analytics.

Since the year 2014, Buffalo Grove, Ill.-based clinical research and consulting organization Healthcare Center of Excellence has been tracking how the healthcare sector uses data analytics. J. Bryan Bennett, founder and executive director of HCOE, said about the report of the organization’s third annual State of Population Health Analytics report, which had interviews with healthcare executives, survey responses from hospital employees and findings from recent research on health IT.

Here is some highlight of the report:

1. Health IT is a spectrum, from EHRs to decision support. The State of Population Health Analytics report assess hospitals’ evolving use of health IT on the basis of a model developed by Mr. Bennett, and is known as healthcare transformation change model.

The model predicts a technology from non-analytic to analytic-focused.

The suggested timeline starts with descriptive technology (EHR implementation), and moves through phases of diagnostic technology (integration of data sources), predictive technology (analysis and modelling) and prescriptive technology (real-time decision help).

In 2014, many healthcare facilities reported EHR input; in 2015, a ssignificant amount of healthcare facilities began integrating data, like clinical and billing reports.

In the analysis of the year 2016 it was determined that the needle moved slightly above compared to 2015. It’s because people are gathering data, but didn’t know what to do next or how to perform the analytics.

2. High-level data analytics need broad foundation. Before approaching predictive or prescriptive analytics, successful healthcare organizations will need a strong groundwork, i.e. collecting and integrating relevant data.

Mr. Bennett said that, besides technological development, any new project also needs a well-developed foundation on the organizational level which includes strong leadership, a talented team, well-defined processes and clear workflows.

In 2015, they ran a study where they asked participants to write down their top 5 challenges for using healthcare analytics. To which they came to know that, most people think the biggest challenge would be clinical data management or technology, but they realised that it was otherwise; the biggest challenge was able leadership.

3. Team require technical skill sets while soft skills are also important. Leaders need to direct and inspire, to be a leader you need both the attributes.

Establishing a strong team of data scientists can also pose a hurdle to create a competitive data analytics program.

Finding data scientists to work in other sectors like finance or insurance is really tough. And next to find people who also have healthcare experience is more challenging. Small and mid level healthcare organizations are at greater disadvantage, since human resources for new hires seems tight.

4. Prescriptive analytics are one of the various tools. As analytics move closer to the predictive and prescriptive phrases, these tools must be taken as decision support and not a replacement for traditional health care.

The system must not be trying to tell the physician how to practice medicines. The system must be a support for the doctor, who makes that final decision.

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

Stay connected with us this space for more discussions.

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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