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How The Mobile Web Impacts Clinical Trial Awareness & Recruitment

Below listed a collection of resources related to the presentation. Hope these resources will be of use as you deepen your understanding of the mobile Web and explore how to optimize your clinical trial or patient recruitment website for more visitors.

Mobile Use & Behaviour Statistics

As you consider the impact of the mobile Web on your clinical trials, it’s essential to look at mobile adoption and behaviour data for prospective clinical trial participants. The resources in this section are a great place to start doing that.

eMarketer
This publishes a variety of digital marketing research, insights, and reports. This tracks Smartphone adoption in 25 countries during 6 years.

Our Mobile Planet
This website is provided by Google. It permits you to explore mobile statistics in 48 countries and develop custom charts to help you understand mobile behaviour in those countries.

GWI Device Summary
This publishes a quarterly report on the latest trends for smart phones, tablets, smart TVs, and wearables.

ITU Statistics Page
This shares a variety of statistics on information and communications technology, including mobile subscriptions by country over several years.

We Are Social’s Compendium of Digital Statistics
They puts out collection of global digital statistics. You’ll find mobile statistics, as well as social media and general digital statistics.

Creating Mobile-Friendly Clinical Trial Websites

Here is listed the resources to help you assess and improve the mobile-friendliness of your website.

Google’s Mobile-Friendly Test
If you want to assess the mobile-friendliness of your clinical trial website, Google’s Mobile-Friendly Test is the easiest place to begin. Simply type the URL and Google will tell you if its algorithms deem the site mobile-friendly.

Google’s PageSpeed Insights
This is similar to the Mobile-Friendly Test, but it assesses the website’s load time. Results are presented for both a desktop and mobile device. Google considers load time to be important for user experience and uses it as a signal in its ranking algorithm.

Google Webmaster Tools Mobile Usability
Google provides mobile usability information in Webmaster Tools. However, in order to use Webmaster tools you must have reach to the backend of your website.

Google Mobile-Friendly Websites Guide
This website is geared to website developers, but there is some basic information here as well. And even though you may not be a website developer, some of the information here can be useful to help you better communicate with your web developer.

Google Multi-Screen Resources
Our presentation primarily focused on mobile phones, but increasingly websites will need to be designed for multiple screen sizes. Google has a website devoted to educating businesses on how to approach multi-screen design.

Summary

Given with challenges of patient awareness and recruitment, you cannot turn away the increasingly large group of people accessing the Internet with a mobile device. The resources we’ve provided should help you survive and even survive in this emerging environment.

Stay connected with this space for more discussions on clinical research.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

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Biomarkers Or Personalized Medicine: Essential Tools

The application of biomarkers is expanding across all stages in the process of drug development that helps bring about new and innovative practices in the treatment of many diseases, including Alzheimer’s diseases and cancer. With their capability to revolutionize development of advanced therapeutics, biomarkers have become quite important tools.

Dr. Tanja Schubert, at Bioclinica Lab where molecular markers is the focus of research work, co-authored an article for EBR in the April 2017 issue. They started the article taking a look at biomarkers ‘growing role in clinical trials across the entire drug development spectrum from target identification and preclinical tests through Phase 1 studies into post-marketing.

During fact-finding, we came across a report showing about 12 percent of all trials registered in 2013 which included biomarkers with yield measures and/or inclusion criteria. These biomarkers are primarily used in Phase 2 studies, helping to prove that the investigated product has the expected biological effect. As far as Phase 1 trials where safety and tolerability of a new investigational drug is assessed, biomarkers serve as a starting point to identify the most valuable biomarkers for a subsequent Phase 2 study. And over in Phase 3 studies where well-developed and characterized biomarkers are used – they very often prove to be those selected during Phase 2.

Biomarkers Categories

Here we discuss the different categories of biomarkers as defined by the FDA-NIH Biomarker Working Group. The Bioclinica lab now have 7 biomarkers categories.

  • Diagnostic
  • Monitoring
  • Pharmacodynamic (PD)/response
  • Predictive
  • Prognostic
  • Safety
  • Susceptibility/risk

Biomarkers in Precision Medicine
Precision medicine is a quite exciting area in which progress is being made in a number of areas like diagnostics. Biomarkers have contributed to development of precision medicine and continue to create discoveries on what appears to be a daily basis. Companion biomarkers, with their ability to know the response to a specific therapy helps to classify patients into responders and non-responders. Usually co-developed with drugs, companion biomarkers provide essential information on the safe use of therapies.

Biomarker Validation and Qualification
Also they took a look at biomarker validation and qualification, how validated and how performance characteristics of the assay are measured.

You can find out more on this topic and the exciting work going on in biomarkers in the EBR article which can be accessed in their website.

Preview Bioclinica Lab

If you’d like to preview the capabilities of the lab, visit Bioclinica Lab where you can find what they does, how they do it and their growing biomarkers menu. If you have any question you are free to take a moment to submit an online query request form given there, and the researchers will get back with you.

So what do you think? If you are interested in biomarker research then you should take a look at their website to know more.

Stay connected with this space for more discussions on clinical research.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

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7 Advantages of a Site Network vs. Individual Sites for Clinical Trials

When you get prepared for a clinical trial, you might be considering the number of investigative sites that will be required for a successful study outcome. You might also be asking how to best locate and secure the appropriate site services you will require.

One approach is to reach out to individuals, one-by-one until your requirement is met. Another approach is to confer with a site network that has one point of contact and the capacity to fill the trial’s entire requirements. Before you make a decision as to which route is best for your trial, it’s essential to understand the differences between these two options and which one offers the greatest advantages for a study.

Here we mention the advantages of working with a site network versus individual or independently-operated sites:

1. Stability
As clinical trials can last for years, and cover multiple sites and countries, it’s essential to have continuity, especially in the areas of data collection, staffing, and SOPs. Site networks often have the financial backing of large organizations which offer financial stability as well as extensive resources to ensure uninterrupted service throughout the course of a trial.

2. Simplicity
Suppose a trial needs 15 investigative sites. Going the independent site route means 15 different negotiations, budgets, and providers to manage. As the trial carries on, there are 15 operations centres and 15 project managers to maintain lines of communication. Such coordination is quite complex and time-consuming. A research site network offers a unified and simplified approach, easing overall management with a single contract, contact, and operations group.

3. Savings

In addition to providing simplicity, a site network gives efficiency and savings via centralized management and processes, compared to contracting with multiple independent sites. This lowers the resources needed to communicate the needs and oversee the trial.

4. Standardization
Unlike individual sites where SOPs and quality controls could vary from site to site, in a research network, standardization is the pillar. Uniform training is conducted across the board. SOPs are established, vetted, and monitored. Bioclinica strives to meet and uphold all compliance standards. You are assured that the trial will be conducted and the data collected in the same way at every site throughout the duration of the trial. Standardization enables clean, high-quality data.

5. Expert People
Another benefit of a site network is the breadth and depth of expertise that could be leveraged. Whereas an independent site has a limited budget for specialists, a site network is able to make an investment in key opinion leaders, project managers, and patient marketing that could engage additional therapeutic experts.

6. Site Scale
If your clinical trial needs investigative sites in a certain geographic location or on multiple countries, finding appropriate sites could be time-consuming and problematic. But with a research site network that already has a global spread, such problems don’t exist. You simply contact the central management team of the research site network, and the team would recommend the best solution for your trial’s needs.

7. Speed
This advantage is rarely offered by site networks, but which, when it is available, can greatly enhance the speed of your clinical trial: patient recruitment.

How many sites will you require for your next clinical trial? When you select a research site network, the number is not an issue. With one call, you could take advantage of the stability, simplicity, standardization, specialists, scale, and the speed you need to achieve success in your clinical trial.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

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FDA Approves New Abuse-Deterrent Opioid

The FDA has announced the approval of Egalet Corporation’s tamper-resistant pain-relief medication (Arymo ER) – that contains morphine sulfate and uses a physical and chemical barrier approach to make the drug hard to manipulate for the purpose of misuse and abuse – the FDA approved another opioid pain medication which uses a new deterrent technology designed to resist drug extraction through the common routes: oral, intranasal, and intravenous. 

The second approval for VantrelaTM ER, was developed by Teva Pharmaceutical Industries Ltd and is a hydrocodone bitartrate product approved for pain that is severe enough to need daily, around-the-clock, and for which long-term opioid treatment is inadequate.  

Significantly, the FDA approval was based not only on the results of a traditional analgesic clinical program characterized by more standard safety and efficacy measures of pain relief compared to placebo, but was also based on Vantrela’sTM abuse potential based on laboratory studies including human abuse liability, and in vitro manipulation and extraction studies, as well as measures of diversion from larger efficacy clinical studies. 

Modifications, PK and HAL Studies

The FDA issued guidance to assist pharma companies and clinical research organizations (CROs) in developing opioid drug products with potential abuse-deterrent properties.

The evaluation of VantrelaTM took intoconsideration, Category 1 (in vitro manipulation and extraction), Category 2 (human pharmacokinetic studies), and Category 3 (human abuse potential studies as well as evaluation of loss and diversion data) studies.  Across all four VantrelaTM studies the overall rate of diversion was less than two percent.

Human abuse liability studies of VantrelaTM confirmed that healthy volunteers who reported recreational drug use had significantly lower “drug liking,” “overall liking,” and “willingness to take the drug again” on VAS measures when compared to agents that were not formulated to deter abuse.  Moreoevr, studies of the drug formulation when exposed to physical and chemical manipulation showed that VantrelaTM ER was able to maintain its extended-release properties compared with opioid formulations that do not take in abuse-deterrent technology.  To mention, VantrelaTM tablets also retain these properties when taken with alcohol. 

FDA Advisory Panel Review

The FDA approval followed a 14-3 vote last June in favor of the drug approval but without sufficient discussion on Vantrela’sTM abuse-resistant labelling.  

Though the majority of the panel members decided that this product might cut the risk of abuse through swallowing, snorting or injecting of the drug, the overall view was that this represents an incremental gain rather than a novel solution to the problem of opioid misuse.

Besides its benefits compared to existing pain management medications, some panel members remained sceptical of the abuse-resistant properties of VantrelaTM noting the potential to feel euphoric simply by taking higher doses at single time, proposing that VantrelaTM appears to have abuse deterrent properties when snorting or injecting but with less clear benefits when swallowed4

In the end, the advisory panel concluded that the potential of VantrelaTM to deter abuse when manipulated and ingested, or insufflate was found.  Moreover, in vitro studies supported the potential to deter other routes of abuse after manipulation such as extraction for IV delivery.

FDA’s Reaction to the Opioid Crisis

The FDA has now outlined a comprehensive action plan to lower prescription opiod abuse.  This action plan comprise of several wide-ranging proactive strategies which includes to prioritise abuse-deterrent formulations and the development of non-opioid medications.The agency’s strong support for the development of abuse-deterrent formulations has generally followed the interests and progress in technology pioneered by numerous pharmaceutical companies.  Besides the fact that several of these abuse-deterrent formulation products have already been approved there remains a great need for more widely available, less expensive and quite effective

The FDA has announced the approval of Egalet Corporation’s tamper-resistant pain-relief medication (Arymo ER) – that contains morphine sulfate and uses a physical and chemical barrier approach to make the drug hard to manipulate for the purpose of misuse and abuse – the FDA approved another opioid pain medication which uses a new deterrent technology designed to resist drug extraction through the common routes: oral, intranasal, and intravenous.

The second approval for VantrelaTM ER, was developed by Teva Pharmaceutical Industries Ltd and is a hydrocodone bitartrate product approved for pain that is severe enough to need daily, around-the-clock, and for which long-term opioid treatment is inadequate.

Significantly, the FDA approval was based not only on the results of a traditional analgesic clinical program characterized by more standard safety and efficacy measures of pain relief compared to placebo, but was also based on Vantrela’sTM abuse potential based on laboratory studies including human abuse liability, and in vitro manipulation and extraction studies, as well as measures of diversion from larger efficacy clinical studies.

Modifications, PK and HAL Studies

The FDA issued guidance to assist pharma companies and clinical research organizations (CROs) in developing opioid drug products with potential abuse-deterrent properties.

The evaluation of VantrelaTM took intoconsideration, Category 1 (in vitro manipulation and extraction), Category 2 (human pharmacokinetic studies), and Category 3 (human abuse potential studies as well as evaluation of loss and diversion data) studies.  Across all four VantrelaTM studies the overall rate of diversion was less than two percent.

Human abuse liability studies of VantrelaTM confirmed that healthy volunteers who reported recreational drug use had significantly lower “drug liking,” “overall liking,” and “willingness to take the drug again” on VAS measures when compared to agents that were not formulated to deter abuse.  Moreoevr, studies of the drug formulation when exposed to physical and chemical manipulation showed that VantrelaTM ER was able to maintain its extended-release properties compared with opioid formulations that do not take in abuse-deterrent technology.  To mention, VantrelaTM tablets also retain these properties when taken with alcohol.

FDA Advisory Panel Review

The FDA approval followed a 14-3 vote last June in favor of the drug approval but without sufficient discussion on Vantrela’sTM abuse-resistant labelling.

Though the majority of the panel members decided that this product might cut the risk of abuse through swallowing, snorting or injecting of the drug, the overall view was that this represents an incremental gain rather than a novel solution to the problem of opioid misuse.

Besides its benefits compared to existing pain management medications, some panel members remained sceptical of the abuse-resistant properties of VantrelaTM noting the potential to feel euphoric simply by taking higher doses at single time, proposing that VantrelaTM appears to have abuse deterrent properties when snorting or injecting but with less clear benefits when swallowed4.

In the end, the advisory panel concluded that the potential of VantrelaTM to deter abuse when manipulated and ingested, or insufflate was found.  Moreover, in vitro studies supported the potential to deter other routes of abuse after manipulation such as extraction for IV delivery.

FDA’s Reaction to the Opioid Crisis

The FDA has now outlined a comprehensive action plan to lower prescription opiod abuse.  This action plan comprise of several wide-ranging proactive strategies which includes to prioritise abuse-deterrent formulations and the development of non-opioid medications.The agency’s strong support for the development of abuse-deterrent formulations has generally followed the interests and progress in technology pioneered by numerous pharmaceutical companies.  Besides the fact that several of these abuse-deterrent formulation products have already been approved there remains a great need for more widely available, less expensive and quite effective abuse-deterrent opioids.  Obviously, the agency must encourage companies to prioritize the development of nonopioids that do not have the hallmark opioid addictive properties by expediting the regulatory process for these drugs.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

abuse-deterrent opioids.  Obviously, the agency must encourage companies to prioritize the development of nonopioids that do not have the hallmark opioid addictive properties by expediting the regulatory process for these drugs. 

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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 Improve Data Management to Overcome Risks in Clinical Trial Local Language Labelling

The question is how pharma R&D and clinical organizations control source data for local languages. This is currently one of the biggest issues facing clinical trial labelling and packaging. 

At present, companies are struggling to find a reliable way to approve and lock down local language data – leading to the ever-present risk of products being incorrectly labelled, causing financial implications and risk to patient health.

Clinical trials are a global activity. As such, materials for clinical trial are now being shipped across many countries and many continents. Labelling, booklets and where necessary Instructions for Use (IFUs) must therefore be safely and accurately customized not only so that they are in the appropriate local languages, but also to ensure that the problems of those local languages are understood appropriately to communicate well with clinicians and patients. They must also abide by country specific needs; in certain countries additional information, such as the name of the trial organization or specific medication removal notices, has to be stated by law.

There is currently a huge degree of inconsistency in how organizations across the sector are approaching this important issue – some of which are prone to human error. Where companies have developed in-house processes, there are often a number of disparate systems involved in managing language, label/booklet design, approvals and final printing. Conversely, some organizations still rely on onerous manual processes – at great cost in terms of manpower and money.

As pharma companies fight to contain rising development costs, improve the efficiencies and higher ROI, integrated label lifecycle management could make a key contribution to some of the industry’s biggest operational goals.

The current scenario

The supply chain journey for clinical trials materials is very complex and variable. Treatments, that comprise various percentages and levels of a drug and placebo, are packaged to be distributed to clinical trial centres for eventual use with trial participants. The packaging and labelling are handled either by the pharma R&D organization itself, the clinical supplies company or a combination of the two. But, with clinical trials now being conducted on a global scale, the ultimate recipient may be located anywhere in the world.

The challenges


In a multi-country, multi-language clinical trial environment, tackling such a comprehensive range of variable data is a huge issue. To achieve the timely, safe and cost-efficient delivery of materials to a global user-base, companies face a number of challenges. Primarily, they must not only ensure that information is presented in the native language of its intended recipient, but they must also make sure that translations – most often from English into a local language – capture the subtleties and nuances of that local language.


In addition, there is also a large amount of local legislation and country-specific label designs. Currently, companies have various systems in place to manage this – some of which are very good – but few, if any, are joined up. As a consequence, pharmaceutical companies need to do more checks throughout the process – with cost implications in terms of time and expense.

The pharma sector is, heavily regulated. Companies work hard to mitigate risk and ensure quality control, and comprehensive standard operating procedures, understandably, mean that they conduct frequent and rigorous checks to maintain compliance.

And finally, once they have aggregated and consolidated local language data and country-specific label design requirements, companies require to output it to a single-panelled label for print, or put it in a format that can be picked up by a third party that can print the booklets without having to go through further onerous checks. This final aspect is, most crucial with errors at the printing stage likely to be very costly.

Labelling errors could therefore have extremely costly implications. The use of technology that gives secure, remote access can give businesses greater visibility, more control and greater confidence that all aspects of the process have been managed effectively.

Step change to greater efficiency

Tools which provide management across the entire labelling lifecycle could reduce the unnecessary duplication of checks and significantly improve ROI.

For industry stakeholders in Clinical Supplies Operations, the question is: are you doing adequate to increase efficiencies and increase costs-savings throughout the labelling process? The answer will be a collaborative approach to an industry-wide challenge, and optimizing technology to deliver a single secure, version controlled and auditable process to manage the entire label lifecycle.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

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Clinical Research And It’s Findings With Pain Solutions

Pain intensity rating, most often mentioned as a numeric pain rating scale (NPRS), where 0 is no pain and 10 is the worst pain to imagine, has been an essential pain assessment tool in clinical research for decades and in daily clinical practice for more over a decade and a half when it was introduced as a Fifth Vital Sign.

In clinical practice, it was a standard and a mandate that clinicians assess pain as a Fifth Vital Sign and also to intervene with the goal to lessen severe pain in their patients.

But the standards in prescribing opioids are not based on solid science when it comes to long term efficacy. This failure is combined with the lack of even basic standards in assessing pain in clinical trials, beyond pain intensity ratings, such as assessment of side effects of analgesics and patient function. To find a better pain lowering candidate with lesser harm to health is another highest paid clinical trial of the world.

In clinical research this pain assessment tool has been viewed as imprecise and nonspecific to assess complexity of pain as a research subject on one hand and as insensitive to change when therapies are administered.

To overcome the issue of imprecision of NPRS and other related issues, currently the FDA has taken a step to remove this concern by supporting a study to establish a more appropriate pain rating tool or an outcome measure in acute and chronic pain trials.

Now it is up to professional pain societies to come together with pain clinical and research communities and to engage in a dialog about how to develop a pain assessment tool or tools that would reflect the complex nature of pain on one hand and versatility and ease of use in a wide range of settings where pain assessment is critical.

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 courses. There are several clinical research phases and different types of clinical research studies, so you must be updated with the basic knowledge to earn a good job in the field.

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. Good companies owe you a good clinical research salary

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

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Could Customized Prescriptions Make It’s Way

In the current years, scientists and physicians have become more interested about customised medicine in which doctors could prescribe the best available medicine to their patients based on the results of a genetic test. 

Current medical practice is quite advanced from the early practices of olden times with the practice of many misguided procedures and bumbling diagnostics left in the dust by powerful tools, precise measurements and proof-based judgements.

To mention among modern medicine’s the proud achievement is the randomized clinical trial. A published feature “On the Button,” in the magazine, Stanford Medicine, says how it works.

Number of participants are randomly allotted to one of two, sometimes more groups. One group gets the test drug or the procedure being tested; the other is given a placebo or undergoes a sham procedure. It’s a blind study where patients don’t know which option they’re getting or even better, double-blinded are the investigators and their assistants don’t even know, either. Once the trial’s active phase finishes, rigorous stat analysis decides whether the hypothesis, considered in advance of the trial, was fulfilled.

To mention, there’s a loop hole in the body of randomized clinical trials conducted till date:

In their effort to achieve meaningful results, investigators tend to choose participants who are a lot alike in terms of age, sex, ethnicity, medical conditions and treatment history. Yet the average patient, who walks into a doctor’s chamber, seldom resembles a patient present in those trials.

Most of them are square pegs in the hole of clinical-trial results. Medications that works great and appear promising in one ethnic group could work too badly in another. Older people metabolize drugs more slowly than younger ones. Males and females could respond quite differently to the same drug. And people frequently are suffers from more than one medical problems.

Not to worry, new technologies might allow the rest for us, who don’t neatly fit the description of the subjects for whom one or another clinical trial has shown that one or the other method or medicine is most appropriate to benefit from the real-life outcomes of medical practice as performed on people whose description like age, sex, ethnicity, constellation of conditions, and the like closely matches our own.

In a 2014 Health Affairs paper, three Stanford faculty members – Nigam Shah, MBBS, PhD; Robert Harrington, MD; and Christopher Longhurst jointly proposed the use of sophisticated computer algorithms to quickly find through millions of patients’ electronic health records for cases that most closely resemble that of the patient present in front of a physician then and then, report the health outcomes of particular methods or medications prescribed for those patients and, thus, give the physician the best guidance in the absence of a clear-cut clinical trial outcomes applicable to a particular patient.

With computational and telecommunication merge and speed accelerating, EMRs has become more universal, and medical systems getting better integrated and interconnected, we could be on the cusp of a pattern shift that will bring personalized remedy to everybody.

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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Its A Question To Either Migrate or Not? How It Must Be

You have a new eTMF technology that you and your team dreamt about!  Finally, TMF documents could be loaded without a second thought to inspection because a new system provides instant access on your computer screen to what is present or not.  It’s called TMF utopia or so you thought.

What are the advantages associated in the implementation of eTMF?

There are SO many advantages to implementing an eTMF system, like:

  • Improved inspection
  • Immediate reach out to TMF documents
  • Remote look of the TMF
  • Improved study start-up
  • Accelerated study closure

But, despite the benefits associated with eTMF implementation, there are some unspoken limits.  Let’s discuss one in particular, i.e. migration!

When a company decides to implement an eTMF system, it’s typically overzealous and wants to migrate everything from its legacy system into its new shiny system.

What is the objective of TMF migration?

While an eTMF system is the most cost-efficient and time-effective way of managing TMF documents, the migration of content from a legacy system must be taken into consideration before execution. In order for the implementation of an eTMF system to provide maximum benefits, a company must conduct a proper assessment of its TMF landscape to achieve a balance between risk reduction, effort, and cost.

The objective of TMF migration must be to lower the risk by progressing the right studies into the new process and supporting technology.  Hence, the key is to determine which studies to move into the newly implemented eTMF system and which should be archived in the legacy systems.

What are the essential components of a comprehensive Migration Strategy Plan?

There are several factors that are relevant in deciding which studies must be moved during the migration period of an eTMF implementation.  A precise Migration Strategy Plan must be developed to clearly write which studies are in scope and who will migrate the documents and how.

The following factors must be taken into consideration when developing a Migration Strategy Plan:

  • Resources – Most migration projects need the use of some heavy lifting including but definitely not limited to:
    • TMF index mapping from the previous filing system to the new one
    • Scanning of paper documents
    • Copying documents, which includes copying and pasting documents from one electronic system into the eTMF
    • Document quality control

If you do not have the human force to do this internally, trained out sources is a must!

  • Study status – Is the study in start-up, ongoing, completed, or cancelled? It might be obvious to migrate a study that is in start-up or ongoing and in general, I agree.  One of the main things to consider for ongoing studies are how long they have been ongoing and what are the timelines for completion.  For completed and cancelled studies, you need to measure the need of migrating these documents:
    • Is this a critical path?
  • Are there documents generated for this study that may be used for other studies?
  • Document Quality – Quite simple. Confirms that the migrated documents are of highest quality.
  • Disruption to study teams – During the migration process, instructions and guidance are important for study teams to be able to conduct their business as usual. TMF filing and processing can’t stop because of a migration project.
  • Archival – If every document will not be migrated, what is the plan for the documents that remain in the legacy TMF? A clear and good plan must be put in place for closing and archiving documents that won’t be migrated.

Migration in simple is to plan.  Have a precise plan with tasks, owners, and milestones and manage and supervise the plan along the way.  Keep all stakeholders informed during the migration process.  Finally, ask for help when needed!

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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3 Ways to Improve Clinical Trials Awareness

Clinical Trials Awareness

If you own a social media account and work within the medical field, chances are quite high you have seen multiple graphics, hashtags and posts over the last couple of weeks that mention Clinical Trials Awareness.

Also advocating Clinical Trials Awareness, the Association of Clinical Research Professionals (ACRP) is celebrating Clinical Trials Day on May 19. ACRP’s aim is to help raise clinical trial awareness and honor clinical research professionals by recognizing their contributions to health-care and medical progress.

To Throw Our Hat in the Ring

GuideStar is joining the cause by sharing some figures surrounding patient perception and clinical trials awareness.

As you might guess, or possibly experienced, low awareness of clinical trials is a leading cause for the lazy enrollment numbers research programs are experiencing.

Below are three steps any program can take to help enhance patient perception and clinical trials awareness:

1. Internal Marketing

According to a research, only 7% of Americans have been informed by their doctors of research studies for which they might be eligible. Multiple factors can lead to this lack of information sharing, but internal awareness is consistently a shortcoming.

One of the biggest hindrances to physician buy-in and participation is a lack of knowledge of the resources made available to them. Clinical research could often seem overwhelming to busy physicians and their staffs, primarily due to inexperience or time commitment.

The best way to combat these challenges is by marketing your research program’s supporting resources to your physicians. Educating physicians in your organization can be as simple as making phone calls and visits, or scheduling meetings with them. Make recruitment procedures easier for physicians by giving posters, brochures, bulletins and an updated website.

Also consider to recognise some tactics, such as letter of gratitide for physician who have recruited patients, as well as keep the docs informed of how their patients are doing throughout the trial. fk

2. External Marketing

There is a wealth of external marketing opportunities available to your research program. Before creating a strategy, try to consider how marketing clinical trials is different than other marketing skills.

With these restrictions, look for both conventional and new media marketing opportunities to create awareness for the organization’s clinical trials programs.

When considering conventional media, news releases are a way to create earned media promotion of upcoming trials. Paid media promotion, like newspaper, magazine, radio and TV advertisements are also good methods for delivering your message to a wide range of people within any given community.

New media opportunities like digital and social media are effective avenues in which to reach highly-targeted audiences. Placing news releases and genuine clinical study information onto the organization’s website sends message directly to the people looking for it.

3. Community Outreach

Nobody knows your community better than you. Take benefit of that knowledge and use it to generate more awareness for your clinical trials programs. Build your network with local leaders and influencers, join programs and go to local events.

Other opportunities could be creating awareness events of your own. Host a lunch meet dedicated to awareness of a cause or throw a tea party celebrating one.

Think of many ways you and your organization can get involved, and educate people on the clinical trials in a research program.

GuideStar colabs with hospitals, health systems and physician pClinical research jobs in Puneractices around the country to build and support clinical research programs.

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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Clinical Research Courses,Training In Pune With 100% Job Guarantee

India is becoming a Research hub and Clinical trial industry is pegging pegged over Rs 3,500 Crores and is growing at 10-12% annually. The clinical research sector is growing at an amazing rate and opening up a wide scope of career opportunities for trained professionals. There is a massive demand for Clinical Research professionals in clinical trial management, Clinical data Management and authorities regulating ethical issues related to clinical research. This makes it an interesting career option with massive growth potential.

Clinical Research Courses,Training In Pune With 100% Job Guarantee

Clinical research Industry is all set to become the next big thing in India. A large population with a good workforce and cost benefits influence big companies to set up research facilities here. Also due to the prevalence of a wide variety of diseases, which includes widespread cases of cancer and diabetes in India. These trials make way to the development of new drugs and trials are conducted on human subjects after the abundant satisfactory information has been collected on its quality and safety through various phases pre-clinical studies and needs an approval from the respective health and ethical authorities.

In light of such massive expansion of clinical trial labs in India, Clinical trial data management and statistical analysis is one such area that is growing rapidly, besides other related fields.

Among the very few training institutes in Pune that offer clinical research courses, CRB Tech Solutions Pune offers real time and focused clinical research training program. Our program is designed to transform Life Sciences graduates into efficient professionals who will add value to the companies who hire them. Our training course includes theories , internship, and development of soft skills that will increase your chances of employment, way ahead of your contemporaries.

You might find a few institute of clinical research that provide clinical research training in Pune but the need to take the right decision and follow the right institute in making a bright career.

Eligibility Requirements

Any one of the following minimum qualifications is eligible:

MBBS, BDS, BAMS, BHMS, B.PHARM, B.Sc. (Life sciences, Biotech, Nursing), Post Graduate Diploma

Mode of training

Class room training

  • 4 Months Job oriented Internship Program

  • Training and Internship in CR & CDM

  • Access to live projects in Pune

ENROLLMENT

Offered twice a year.

Payment options:

With credit card & debit card, payment options for fees is flexible.

What sets up apart?

• 100 % placement guarantee on paper

• We offer LOI (conditional offer letter) from our clients

• Unlimited placement calls for both alumni and freshers

• Known for best walk-in drives.

• Placement with lifetime support.

• Mentoring by very talented corporate expertise faculties.

• Train in German language and hence enhance your abroad prospects.

• Personality development training which will benefit you in developing soft skills hat would help you in cracking interviews which are very important in standing up among other contemporary candidates in competitions.

• 95% practically oriented training sessions.

• Good diagnostic Infrastructure and departmental infrastructure

A Training Program tailored for you:

• Detailed and expertise training is additionally offered alongside customized technical training to guarantee the general development of the students.

• Foremost curriculum: The modules of Clinical Research Training Program are upgraded and redesigned on a periodical basis by our industry expert.

• Guidance from professionals of the field

• Campus drives take place regularly: We have enlistment programs where a large number of our placement clients visit our organization, regularly.

• Aptitude training and interviews: Training in aptitude is a part of the syllabus as it enables you to successfully overcome the hardest of the aptitude tests, which you would face in the interviews. Mock interviews are taken to acquaint the students with real clinical research processes in ongoing research labs with an efficient study team, such that they can face real interviews with more confidence.

• Computer lab, course material, live projects?

Rules, and Regulations:

• Compulsory 90% classroom attendance.

• Proper dress code is a must in the class.

• Earn a support amount with no burden of fees.

Course Outline

Module 1

Preclinical Research

  • Drug Discovery & Development

  • Preformulation Studies

  • Formulation & Ingredients

  • Animal Research And Trials

  • Introduction to Clinical research

  • Introduction to pharmaceuticals

  • History of Clinical Research

Module 2

Clinical Research (core)

Clinical research process flow

  • Guidelines for Good clinical practice (GCP)

  • Essential documents

  • Preparation of IB

  • Preparation of Protocol,CRF,ICF

  • Quality Analysis in Clinical Research

    Bioethics and Clinical Research

    • How the ethics committee regulate

    • Pharmacovigilance

    • Regulatory affairs and regulatory submissions

    • Guidelines in clinical research

    • Career pathway in Clinical Research

    Module 3

    Clinical Data Management

    • Overview of Clinical Data Management

    • Overview of Electronic data Capture

    • Protocol Review

    • Data Management Plan

    • CRF Designing

    • Lab Data Handling

    • Database Designing and User Acceptance Testing

    • Medical Coding

    • I MedDRA

    • CD-9

    • Data Management Standards in Clinical Research – CDISC

    • Overview to Electronic Data Capture

    • Designing CRF in MS Word

    • Identifying disparities on CRF pages

    • How to generate queries for the sites

    Course for General Aptitude

    • Percentages Profit And Loss

    • Number System

    • Simple Interest Compound Interest

    • Permutation And Combination

    • Probability

    • Number Series

    • Coding Decoding

    • Blood Relation

    • Puzzle-Based Problems

    Clinical Research Certification

    Certification is presented to candidates only on successful completion of the course and after having paid all the dues with about 90% attendance.

    The management reserves the rights to change, delete, amend or modify its rules & regulations and schedules if a need arises and this will be applied to all the currently enrolled candidates in the ongoing program of Clinical Research Training.

    CRB Tech Solutions reserve the right to update the programs through changes in title, contents, and structure.

    There might be changes in the schedule, postponement and cancellations of the sessions conducted in classes.

    Register

    If you are interested please Apply now.

Related Topics:

1)Requirement of Clinical Research Associate

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

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