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.

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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.

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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.

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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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How To Elevate Clinical Content Management In Current Era

In today’s leading emergence of clinical researches Clinical content management has become a priority and a crucial way towards success. Hence in this blog topicv we shall discuss how to elevate clinical content management in current era.

Healthcare organizations are more recognizing that taking technological infrastructures to deliver the updated clinical decision support to clinicians at the point of care is not only necessary to meet regulatory requirements but also improve the results and costs.

Within a hospital’s bigger clinical decision support strategy, use of order sets has been identified by the industry analysts as a key element for driving uptake of logic-based practices and guiding clinicians to take the best decisions. The challenge is to lay a framework for long-term viability of these tools to deploy; implement and maintain the complex undertakings for the healthcare organization.

In this process one there is one hurdle and that is the ongoing maintenance activity needs to keep content aligned with industry practices, staying with the evolving regulatory guidelines is also challenging. Manual processes and workflows for recognising required changes within a fluid regulatory landscape and fast advancing scientific field leads to compliance challenges.

Rockford, Ill.based SwedishAmerican responded to these challenges by deploying a strategy based on advanced clinical content management technology. The health system has a large good care hospital, medical centre and extended network of outpatient providers and clinics, has been able to streamline set reviews and editing by using quality validation to the front end instead of the back end.

Current Process Improvement:

To identify opportunities

The organization’s clinical content management infrastructure and administration model for maintaining order sets are an outgrowth of that culture and created to lay a foundation for to help sustain with CPOE and example-based practices.

Governance is created on three guiding principles: A) patient’s needs come first, B) clinical users to play an essential role in clinical IT decisions and C) Standard,transparent and responsive IT decision process

Good Quality Review Strategy

The very reason to recognise the significant resources need to keep order sets in synch with the national quality measures, the SwedishAmerican clinical informatics team designed a strategy for streamlining the effort and also minimizing the chances for compliance gaps. It says that a quality validation must be applied to the front end of order set review rather than the back end by using tools within the current clinical content management infrastructure.

An automated system that comprises of updated national quality measures and customized rules is now applied to conduct on-demand gap analyses of order sets and alert the clinical informatics team when content critical to quality measures is omitted or when content deviates from regulatory standards. As revisions are required, compliance issues could be identified on the front ends, and eliminate the bottleneck that previously happened.

When the new workflow and strategies are introduced, clinical informatics team leaders arrange an initial meeting with appropriate quality personnel to recognise the corresponding rules within abstracting methods for various national quality measures. The initial brainstorming proved beneficial as staff were able to identify opportunities to eliminate duplicated efforts between nursing and quality review. Staff also got critical knowledge into the powerful impacts of rules on clinical practice.

Today, the staffs have a greater appreciation of the quality review process and the need of updated clinical content at the point of health care. Processes are also streamlined as clinical informatics professionals are alerted when the quality measures fail the requirement and edits can be made instantly rather than on the back end of review processes. The resulting efficiencies allows rather gives more time for clinical informatics to focus on higher level of clinical initiatives and essentially opened up opportunities to shorten the review deadline.

At the time of initial review of existing order sets, SwedishAmerican was overwhelmed to find that very few gaps were there with the national quality measures. The overall implementation of the new workflow has improved their clinical practice, and staffs are confident that the measures are in form with regulatory initiatives and most significant is that patient care got optimized.

The views and opinions and positions expressed within these blog posts are those of the author and do not represent those of any Hospital Review/ Healthcare. The accuracy and validity of any statements made within this article are not guaranteed. We take no liability for any errors, omissions or representations.

We conclude the discussion now.

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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. It also offers insights into clinical content management that would enhance your skill. With many companies having openings for the clinical content management jobs, our institute will help you find your place ahead of your contemporaries.

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.

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Ways To Develop Powerful Clinical Content System

It has been long years, medical science is researching with clinical aspects, and hence it’s quite essential to develop a powerful content system. Here in this article we shall discuss the ways to develop powerful clinical content system that will help improve the ability to fast integrate new practices into everyday healthcare delivery. The need and development of best clinical content system has made way for many job avenues for clinical content consultants and clinical content specialist

Key Components of the Clinical Content System

Establishing the best content system means developing best-practice care processes the organization can use to drive care improvement. At its most basic, the best content introduces evidence-based knowledge assets into everyday care delivery in a systematic way. And another challenge that comes next is the clinical content management.

How to Create the Content System

The following are important steps for creating a powerful content system:

1. Perform key process analysis. With every organization and its limited resources for improvement initiatives, resources are required to be focused on projects that will likely have a significant impact on real savings and improvements. The key process analysis must examine clinical processes in the organization to demonstrate where the cost variation in care delivery exists. Care delivery processes with lots of variation can be greatly improved by standardizing the process associated. Find out the areas which will deliver the fastest possible return.

2. Understand the population. After determining the care process, the organization must define precise patient registrations. In addition to diagnosis codes, the organization must refine the unit using other elements like procedures, labs, medications, and/or clinical symptoms. This step might sound very straight, but these unit definitions need significant feedback and fingerprinting from clinicians who wants to ensure their criteria for the same.

3. Understand the best practices and current state. Next, the organization must define the best contents that will deliver improved outcomes for the processes that have been targeted and to review and summarize major guidelines, primary literature, and regulatory and accreditation measures.

4. Identify the key metrics: An effective content identifies the key metrics that clinical content analysts shall need to track the success of the improvement initiative. So identifying them is a must.. When best content get identified, decisions on the best way to measure those contents get installed.

5. Define specific goals: Next focus is on creating a specific goal(s) to address the marked problem. A smarter approach is to target the intervention strategies around very specific, narrow aim statements. The data which helped identify the variation should help drive these targets too.

Once the best content system in place, putting improvements in a systematic way using two other systems; the adoption system and the analytics system, to mention. The adoption system tells how an organization shares and diffuses improvements throughout. The analytics system helps the organization to measure and collect data required to drive improvements.

How to create an effective content system

A few are mentioned here below:

  • You need to select an analytics vendor with robust content starter sets. Define the populations and determine the best practice that must be applied to each care process is difficult and a tedious work. The best vendors did work by developing starter content sets. They’ve analyzed and prioritized the clinical care opportunities and defined the required patient populations. They’ve mapped out the care processes and identified best content that can be applied. Having this work done in advance; speeds the entire process.
  • Initiate with a starter set; but refine any definitions and processes to fit the needs of the organization. People with core knowledge like nurses, physicians, course leaders, finance, etc. must collaborate to refine the starter sets to match the needs of their organization. This hands-on work with the starter sets is significant. It gives key players in the system the chance to track these improvement processes.
  • There won’t be worry about having everything perfect. Instead, expect a frequentative approach. Put the best content system in place as fast as possible. Then, in due time the analytics system will deliver valuable insight and metrics that will help the team twist and refine the content.

Always remember that the best content system creates a foundation of consistent processes to guide enhancement initiatives. This method is an important and efficient tool for achieving clinical integration and improved outcomes across the organization.

We conclude the discussion now!

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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. It also offers insights into clinical data management course that would enhance your skill. With many companies having openings for the clinical data management jobs, our institute will help you find your place ahead of your contemporaries.

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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Gun Violence Another Emerging Public Health Crisis

Owing to the Florida mass shooting, Dr. Eric B. Larson asked if the society is prepared to make changes around guns and related researches.This blog topics shall discuss how to respond to the gun violence; another emerging public health crisis.

Orlando gun shootout witnessed 49 dead and 53 injuries. The shootout took place at a gay nightclub. When this terrible thing occurred, the US had already experienced more than 100 mass shootings since the start of the year. Unfortunately per the gun violence statistics; gun violence increased.

Even the gun violence by countries to occupy lands and create havoc is being witnessed in Syria and those related places.

It’s a known gun violence fact that more guns mean more deaths. A seminar study from 1993 by Drs. Arthur Kellerman and Fred Rivara, linked gun ownership to homicide in a home. GHRI Affiliated Researcher Dr. Amy Bonomi recently reviewed the dangers of firearms in domestic violence situations. 2/3rd of gun deaths are suicides, which is a major focus of Dr. Greg Simon’s research.

It appears that more people are demanding action on the shootout issue. In response to the Orlando shooting, support for the LGBT community surged. A supposedly half a million of people attended the Seattle Pride Parade in the later half of June. The American Medical Association (AMA) announced U.S. gun violence a public health crisis.

Politicians are also listening. Recently, Senator Chris Murphy of Connecticut and Representative John Lewis of Georgia called for votes on gun laws. And now the gun violence definition is changing, it ranges from domestic vioelence to mass shootout.

These events are meaningful in light of Birnbaum’s Lecture by Baltimore City Health Commissioner Dr. Leana S. Wen. She spoke on and emphasised that safe neighborhoods are the most crucial contributors to health. She advised some simple, and specific actions that can call upon to improve social factors of health.

For instance, Dr. Wen reminded to always make the case for health when developing public policy. With more than 30,000 firearm deaths a year, saying that gun violence is a health issue is not difficult. Dr. Wen urged everyone to speak up and discuss the matter. Likewise what to do when united stand against violence, racism, and discrimination. Surprisingly, lowering gun violence was the most talked-about issue when Dr. Wen met with public health representatives and local advocacy groups in a session hosted by Group Health Executive Vice President of Marketing & Public Affairs and President of the Group Health Foundation Diana Rakow.

Act to build safer communities

To question ourselves, what else can be done to respond to the shootings in Orlando and other cities? As individuals, what actions must we take to make our communities safer. Dr.Wen addressed the health care professionals and said that we should remember to watch for signs that the patients might be at risk of gun harm. It’s time to protect people who are vulnerable to discriminations because of their ethnic or racial group, sexual orientation, religion or gender identification.

She also emphasised that we must remember to celebrate our diversity. She urged people to get involved in activities that make the communities more good and inspire all as a citizen.

She also said being in London, she’s experiencing a different political atmosphere as the residents ponder their relationship with the European Union. She said that she’s participating at a Lancet Commission meet where they would be finalizing a major paper on Alzheimer’s disease and dementia.  She said that her topic is on resilience and she’ll have some thoughts on that.

Finally she concluded that she wants to point out that although the commission is sponsored by the the UK, it has involved widespread cooperation and engagement across Canada, the European Union, and the US. She said it hardly matters what happens with Brexit, a good sense of common purpose is alive and well in people all around the world. She said that they are working together to improve public health through researches, development of policies development, and with own actions.

We conclude the discussion here.

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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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How Google Helps With Clinical Trial Studies And Awareness

Google handles over millions of searches in a year. These stats don’t include even 1/3rd of the total searches worldwide as Google’s global market share is about 70%. We all know that the search engine queries offer many options into people’s thoughts and questions. In this article we shall discuss how Google helps with Clinical Trial Studies and awareness

Using an aggregate search query data, we can better understand the powerful clinical trial participants. And understanding is essential to improve the clinical trial education and awareness. A number of software or search tools nowadays give you access to search data, but Google’s tools are the most popular. Google’s Keyword Planner is freely available, but it can take little time for you to become proficient with it.

An Experiment With Google Autocomplete

Autocomplete is a real-time suggestion Google offers as you type a query. These suggestions are based on various factors like previous queries from other people. The prior queries inform autocomplete, it can offer you a collective choice around different topics.

If you really want to analyze search engine data, there are better, more sophisticated ways. But this is a quick and easy method for getting some good insights into the general public’s thoughts and questions about clinical trials.

Take a look at the searches or questions below; and see Google’s autocomplete suggestions for them. Here how it appears.

Do Clinical Trials

Do Clinical Trials
Do Clinical Trials work

Do Clinical Trials cost money

Do Clinical Trials drug test

Do Clinical Trials pay you

How Clinical Trials

How Clinical Trials

How much do Clinical Trials pay

How long do Clinical Trials take

How do Clinical Trials work

How to find paid Clinical Trials

How Do Clinical Trials

How Do Clinical Trials

How Do Clinical Trials work

How Do I sign up for Clinical Trials

How Do you get paid for Clinical Trials

How Do cancer Clinical Trials work

When Clinical Trials

When Clinical Trials

When to use a placebo in Clinical Trials

When are placebos used in Clinical Trials

When Clinical Trials go wrong

When Clinical Trials went wrong

The above mentioned are only a few examples; there are many.

Quick Ideas for Clinical Trial Education

Seeing with Google’s autocomplete suggestions, I think you can learn the following. People’s conceptions and questions about clinical trials could be addressed with two main types of education options: basic and protocol specific. Autosuggest provides idea into educational themes that need to be or are being addressed within the search categories.

Basic themes found in autosuggest practice are the following:

  • What is a clinical trial?
  • Do clinical trials work?
  • Why do clinical trials exist?
  • What are the clinical trial phases?
  • What are placebos?

Protocol-specific themes in autosuggest include:

  • What are the risks and benefits?
  • What is the cost and compensation?
  • How do I find a trial?
  • What is involved in participation?
  • Will I get a placebo?

When you talk to patients, you quickly know when and how to present them with information.

Also remember that answers to some of these questions you will not find online. That’s because the answers are not provided. For instance, most clinical trial websites do not share specifics about what’s involved in patient participation. How many patients become less interested owing to lack of information and never inquire about a study.

In recent years clinical researchers have turned understand patients, but social data is not the only online data to be relied. Search data offers only a unique view into people’s thoughts and questions.

Regardless of the type, online data can be a fast and a cheap form of market research. It’s a wonderful opportunity for you to know and understand the patients better.

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

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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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Career Opportunities in Biotechnology and Drug Development

The world of biotechnology is growing progressively, similar also the career opportunities. But the choices could be daunting. This blog topic on career opportunities in Biotechnology and drug development, is influenced by the suggestions by Toby Freedman.

Many questions linger you, like what types of jobs are available? How do you take your first step? What will your job help you become a Preclinical Project Manager or a “Clinical Process Researcher? Even what is the difference between biotech and pharma?

Toby Freedman is credited to put together a solid resource for getting jobs and your career development in the biotechnology and pharma sector. Toby Freedman’s book is a comprehensive guide which could be an invaluable help to find your first job in the biotech industry.

The very chapters on writing a resume and interview techniques, including informational interviews, are brief but well-written and useful. If you’ve read a lot of career guides, these chapters won’t teach you anything you didn’t heard before.  The real thing about Freedman’s book is the industry-specific information that it has.

In an excellent overview chapter, Freedman defines the breadth of the industry, and briefs the various product development pathways which is followed by therapeutic, nontherapeutic, and medical device companies.

The individual chapters, cover a wide range of career pathways like preclinical research, drug discovery,project management, clinical development, regulatory affairs, medical affairs,quality assurance control, product development, business development, sales, marketing, and corporate soft skills.

The chapters on executive management, finance, legal affairs, and even recruiting got featured in this comprehensive guide of Freedman.

Each chapter in the book includes summary of various roles and offers a thoughtful analysis of both the positive and negative aspects of a said job.  For instance, in clinical development, Freedman notes that “Original and applied clinical research is exciting.  The results are unknown until trials are completed, and each trial process is unique. The work is close to the market, but there is frequent need to meet the constant looming deadlines, and the objectives often appear to be too much, sooner, with very little. Freedman suggests that when you begin, try to decide which path to follow, must know the downside of a job which could be a very useful information.

It’s natural to discuss salaries and compensation, as this is another potential for career development, and a look at how future appears might make an influence on job security.

Keeping in mind what is more usefull for job seekers, Freedman clearly lays out job requirements and typical pathways to the role, and provides tips that could be helpful for getting one’s foot set ahead. With descriptions with how one can excel in a role, and qualities common to good candidates Freedman has really mentioned the most practical aspects in this career prospect.

The guide isn’t so cheap, and even not very portable; but if you are seeking for a career in the pharma and biotech industry, the guide by Toby Freedman must be at your side.

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 help you moving forward in a clinical research career  in the field of life science.

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The Latest Trends In Clinical Research

Pharma costs are the growing components of health care costing today. Pharma R&D is a process discovering, developing and bringing to market novel drug products and is a significant cost contributor. Clinical research, an important sub-process in pharma R&D, ensures quicker returns on investments made for the pharma company and drives access to a better patient care.

Pharma R&D has 2 objectives: novel drugs and new markets But, pharma companies today are under economic and regulatory pressure than before. On the other hand, IT is driving a greater adoption of evidence-based platforms for information management and dissemination.

A few trends in clinical research discussed here say that the industry is searching for opportunities to enhance efficiencies of their processes of product development for quality delivery.

Clinical research outsourced

The costs of drug development rose up in the past decade, forcing pharma companies to look for innovations and smarter ways of doing business. One of the major in trends that have come up from high costs is companies outsourcing their clinical trials. By outsourcing, pharma companies reshape the drug development services industry. They have grown from just a few companies providing limited clinical trial services to big MNCs providing various services like preclinical assessments, study design, clinical trial plans and management, data monitoring, bio-stat analysts and many more. CROs have been providing preclinical and clinical trial services, but they are broadening their expansion into project management.

Electronic records made research easier

Another way to reduce cost pressures is to shift clinical trials to lower cost areas. Globalizing clinical research provides CROs with an opportunity to run clinical trials efficiently and at a lower cost.

The outsourcing market has evolved into 2 segments large sponsors that emphasise partnerships and functional outsourcing, with in-house PMs and small sponsors opt for turn-key solutions.

Adoption of electronic records

Another trend that is fast evolving is to go paperless and increase in the acceptance of electronic records. A novel drug application has hundreds and thousands of paper records. Adopting electronic records has made searching and analysis easier and also improved efficiencies of other initiatives to lower the costs of development and data management in clinical trials. These are several technologies that support the electronic data capturing and also the clinical trial management systems for information on administration.

But, in comparison to changes in the ways of clinical process teams and the developments in web based communications tools, the progress towards a complete paperless clinical trials is very slow. Experts say that the attempt is to adept EDC for all new trials and selectively digitize the ones done in the past is also required. Going the e-way permits for better collaboration across various stakeholders in the clinical trials processes.

Enabling an integrated clinical enterprise

One of biggest challenges of life sciences industry is to face the need of integrating the information that exists from discovery through clinical development and commercialization. The next trend relates to integrating the collected data, data management, data repository and safety data under one roof along with giving a new definition to the business processes and technologies within an organization. Several large pharma companies have their own initiatives in this sector.

The processes of such initiatives are around defining standards for clinical data. It might take years to complete the implementation of such initiative. There is a due consideration of the need to put together domain and technology skills and achieve the benefits by the pharma company and the world at large would be significant considering the impact this would have on bringing the drug to the marked safety, quickly and cost effectively.

Conclusion

These emerging trends in clinical process indicates a shift from efficiency centric approach to a broad based effectiveness oriented approach.

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 opinion 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 

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ORCATECH Or A Technical House For Clinical Research

In this article we shall discuss about ORCATECH or a technical house for clinical research. It’s an R&D centre formed while combining with the neurology and biomedical engineering departments at Oregon Health and Science University.

Judith Kornfeld and her group developed a system for clinical research based on remote sensing and computing whereby data is collected without any obstruction and continuously. ORCATECH installs sensors in patient homes, rather than outfitting patients with wearable devices, to monitor patient activity.

Here is what Judith had to share with a leading magazine.

About ORCATECH’s technology.

ORCATECH technology was developed to allow the patient’s daily life be the source of data to measure health changes and meaningful outcomes in clinical research.

In essence, the approach to data collection in clinical trials has not changed since such trials were first conducted over 250 years ago, while medical technologies for treatment and drug development have advanced incredibly.

Moreover, this approach to clinical trials requires a smaller sample size per clinical trial by an order of magnitude, and the ability to detect change and response to therapy is much faster because of the density and the plurality of the data.

What are the types of data you’re collecting?

The main types of data are the movement around the house, walking speed, leaving and entering the house, sleep measurements, computer usage, balance, weight, medication, socialization and more.

This is an open platform and can use any sensor that collects data that is of interest to the questions asked in a clinical trial.

Is this dense data ?

Yes, because it’s consistent and usually collected 24/7.

There’s a potential for too much data, right? What are the data considerations then?

This is a very important question. There is never really “too much data,” it’s all about making sense of this gold mine. In a way, that’s the secret sauce of ORCATECH. It’s the algorithms developed here that take all this data and interpret it into essential clinical information.

These are digital biomarkers?

Exactly. These are digital biomarkers that can be obtained in a very accurate manner that reflect the patient’s parameters of real life. We measure what you want to improve. With medical treatments you want to improve patient’s lives. We are able to measure those parameters.

Digital biomarkers are a new concept. What are some of the considerations for adopting these within the pharma industry?

One has to think about compliance. If you’re wanna use a device, you need to consider how it’s actually being used, how accurate it is and how it reflects what you’re trying to measure?

Here emphasis is on multi-source data to get a real and true picture. It is also ensure before collection of the data how patients will interact with the sensors. Focus groups are conducted to see how patients might use it and how it relates to real life.

The whole idea is to collect something that is ecologically valid, and the patient is doing something in a manner they would do daily. It is important to not use a single device and follow one data stream that is isolated from fact.

Emphasis is being less dependent on patient compliance, such that data is whole and accurate. In our system, the only part we rely on subject compliance for is a weekly email questionnaire. This helps us get information that we could otherwise not get, and it puts the data we collect in context.

How there is drug development evolving with technology like this?

There are many compounds out there, but very few get approved. The clinical trial process is very costly, tenacious and not very efficient. Things have to be changed.

There is an effort to lower costs of healthcare, and therefore the cost of R&D for treatments must be reduced, both pharma and medical devices.

It’s not just a matter of using a device in a periodic manner without context. The whole design of the clinical research has to change.

What will trials look like if everything goes well?

They will get conducted very differently than now. The emphasis of the protocols would be to collect consistent and objective data, less reliant on sporadic and often inaccurate reporting of patient, or clinician’s periodic observations sometimes not correlated to real-life testing. The whole process will be more accurate and true, and that’s where hope is things will go.

New technology can actually reduce costs?

New technologies might reduce costs in several ways, but this need to be measured by the cost of technology, the cost of installation and the increased efficiency of the process.

But the real cost benefit happens in the long term, because less sample size and short clinical trials are where the costs savings will be most prominent.

Time in a clinical trial is very expensive, so if you can shorten the time to detect changes or reach an endpoint, you might reduce the cost effectively.

What are the concerns about this type of technology?

Security and privacy; though none of the data collected identifies a person. No cameras or facial recognition, and all the sensor data collected in the home is separated from the identity of the subject.

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

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