Diabetes Is The New Killer Disease For India’s Urban Poor

A current government funded clinical research project to understand the present pattern of diabetes across states portrays that the disease is catching up with the urban poor in the developed states of the countries. The project is one of the biggest ever of the kind, conducted in India. 

The findings of the ICMR-India DIABetes study, published in the international medical journal Lancet, says that the urban areas of more affluent states have proceeded further along the diabetes epidemic. Less affluent individuals have a greater prevalence of diabetes than their more affluent counterparts in the rich states.

Chandigarh, which had the highest per capita GDP of US$ 3433 among the Indian states and union territories, has the highest prevalence of diabetes among the urban poor. The trend remained is same in Maharashtra and Tamil Nadu as well. But, in rural areas of all states, diabetes is more prevalent among the rich than the economically and socially weaker sections of the society.

The report says that as the overall prosperity of the states and India as a whole increases, the diabetes epidemic is likely to affect the poorer sections of the society, a serious transition that has recently been noted in high-income countries. This trend is worrisome because it suggests that the diabetes epidemic is spreading to those individuals who least can afford to pay for its management.

The researchers claimed that while the previous studies did not sufficiently capture the heterogeneous nature of the diabetes epidemic in India, the ongoing study aims to estimate the national prevalence of diabetes and pre-diabetes in India by proper estimation of the prevalence by state.

The overall prevalence of diabetes in the 15 states of India was 7.3 per cent. The prevalence of diabetes varied from 4.3 per cent in Bihar to 10 per cent in Punjab and was higher in urban areas (11.2 per cent) than in rural areas (5.2 per cent) and higher in mainland states (8.3 percent) than in the northeast (5.9 per cent).

The overall spread of prediabetes in all 15 states was 10.3 per cent. The presence of prediabetes varied from 6 per cent in Mizoram to 14.7 per cent in Tripura, and the presence of impaired fasting glucose was generally higher than the presence of impaired glucose tolerance.

Age, male sex, obesity, hypertension, and family history were independent risk factors for diabetes in both urban and rural areas, the study said.

The researchers mentioned that the rural prevalence estimates are much higher than identified in earlier studies. Given that approximately 70 per cent of India’s population resides in rural areas, even a little increase in the rural prevalence of diabetes will translate into several millions of individuals who will need chronic care. To mention about the additional burden that arises due to the overall younger age of onset type 2 diabetes in south Asian people compared with other populations, the pressure on our country’s health-care system is to be immense.

The study has been funded by the Indian Council of Medical Research and Department of Health Research, Ministry of Health and Family Welfare.

We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of proficient candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Why Is It Significant To Share Data from Unsuccessful Clinical Trials?

A recent proposal by the U.S. Department of Health and Human Services have chances to expand the number of clinical trial data that drug companies should share with the public. As per the proposal, clinical trial sponsors would be needed to report findings for drugs and devices that fail to reach approval.

Launched in 2000, ClinicalTrials.gov houses registration data for all trials regulated by the FDA, currently having more than 175,000 trials. Current regulations need drug companies to submit summary results, within a year of trial completion for drugs and devices which receives approval.

Under the new proposed rule, companies will also be needed to report results for unapproved products, which will add to a significant amount of publicly available data. Phase I clinical trials, designed to test the safety of a drug or medical device don’t fall under the subject of the proposal. But, the NIH now plans to put in place a rule that needs submission to ClinicalTrials.gov results from all clinical research sites that it funds, irrespective of how pace and size.

To Share Clinical Trial Data for Unapproved Compounds:

Why this Change?

A recent analysis of 400 U.S. clinical trials discovered that even 4 years after the trials had been completed; nearly 30% had failed to share results by publishing in a scientific journal or reporting in ClinicalTrials.gov. Moreover, there are chances for negative clinical trial results to make way into the scientific literature compared to positive results. Hence, these data covers a large number of studies and are significant to clinicians, scientists and the public.

Here we mention three reasons you should bother about negative results from a clinical trial:

  1. Sharing Negative Results is Helpful for Scientific Research.
    When it comes to clinical trials, transparency with data helps in researches to avoid repeat of failed trials. This lowers the risk for clinical trial participants, who are volunteering their health and life to the trial. Negative results also guide in future research and helps in the design and implementation of improved trials, deleting repeated scientific works for which you know the answer, but not published.
  2. Sharing Negative Results Is Ethical Responsibility towards Volunteers.
    The clinical trial process depends on the voluntary participation of human. Many at times, participants join a trial not only for a benefit of personal treatment, but also for improving the lives of others in future. Sharing clinical data helps to maximize the benefit of each trial and helps to reward their participation who has donated their time and efforts to the trial.
  3. Enhanced Public Trust
    An increase in the transparency will help earn and an increase in trust between the public and the drug developers. Sharing clinical trial data with scientific community, worldwide will also increase trust between the American taxpayers and the National Institutes of Health (NIH), who use their funds to sponsor many clinical researches.

The HHS and the NIH will be taking public comment on the two proposed policies until February, next year. It would be interesting to see the responses to this proposed change.

We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of proficient candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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5 Reasons Why CTMS Are Better Than Excel Spreadsheets

To manage clinical trials using Microsoft Excel is a norm within the clinical industry, mainly for smaller research sites. But, as clinical trials increase in complexity and research sites grow, spreadsheets become a liability and hindrance for your site.

Instead of technological advances in software solutions that increase the accessibility and affordability of clinical trial management systems or CTMS, many sites still rely on spreadsheets.

Here are the 5 reasons why spreadsheets can’t keep pace with a CTMS.

1. Inefficient Workflows

Spreadsheets are cheap, straightforward and customizable, but they are not designed for clinical trials. Excel spreadsheets give little or no visibility in supporting tasks within a study, and hinders multiple users from editing the spreadsheet at once.

A great benefit of a CTMS is that it’s designed to create efficiencies in your day-to-day operations so that you could spend less time managing the system itself, and more time focusing on the demands of the trial. Clinical trial management systems must have prescriptive workflows in built, making it easy to identify and follow the next step. Some CTMS’s automatically exhibit or hide particular attributes according to the user, to enhance efficiency across different roles.

2. Lack of Data Safety and Integrity

With multiple stakeholders in managing several aspects of clinical trials across your site, it is essential to track who is responsible for which data to make sure data reliability and lower human error. A spreadsheet does not provide the ability to limit access to sensitive data, and it cannot be used to track the edits.

Whereas, a CTMS offers far greater security, since it is only accessible to users who have unique usernames and passwords. Moreoevr, a CTMS must offer audit trail functionality, whereby application administrators could view which users edited, such that they can identify and resolve any input errors.

While using spreadsheets, users might accidentally delete data with the press of a button. A cloud-based CTMS is backed up consistently, to revert to a former version of the CTMS and recover things that might be lost accidently.

3: Inability to Scale

To grow your site successfully depends on your ability to efficiently scale up. As your site continues to grow, take over complicated studies, or enhance your research volume, smaller inefficiencies in your workflow will act as a hindrance for your site obviously. Using a spreadsheet divides all of your protocols across different files, whereas a CTMS can track all your protocols and associated documents within a central system.

4. Limited Reporting Capabilities

Creating reports in Excel takes time away from billable tasks and other essential elements of managing a trial. Spreadsheets are limited by data point formats, and need frequent rebuilding and running. But a CTMS, could report in multiple formats at the push of a button. A CTMS must also offer standard off-the-shelf reports, which includes data points from other sites as well.

5. Lack of Integration with other solutions

Besides CTMS, there are a number of other technological solutions that could help your site meet its operational goals. While you rely on spreadsheets, you miss out on the opportunities to combine interfaces in other systems to further streamline your daily processes and give insight across departments.

Though, spreadsheets are an option for managing clinical trials, their lack of customised features specifically to the trial process could compromise data, stop operations and bog down your site staff.

We conclude now.

In the competition of many organisation CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of proficient candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Designs And Methodologies Of Clinical Trial Researches

Methodologies Of Clinical Trial Researches

These resources explain key terms in precision medicine and clinical trial types and designs. Definitions are provided below.

I. Precision Medicine Trials and Important Definitions
II. Other Types of Trials and Important Definitions
III. Statistical Considerations for Trial Designs and Methodologies
IV. Clinical Trial Terms — Resources

I. Precision Medicine Trials and Important Definitions

Precision medicine is an approach for treatment of diseases and prevention that takes into account individual variability in genes, environment, and lifestyle for each person. It helps doctors and researchers to accurately predict a treatment and prevention strategies for a particular disease that will work best in certain groups of people. This approach is in contrast to conventional practices.

  • Basket Trial: Basket studies test the effect of one drug on a single mutation in a variety of types of tumor,at the same time.
  • Umbrella Trial: Umbrella studies have many different treatment arms within one trial.
  • Targeted Therapy: A type of treatment that uses drugs or other substances to identify and attack specific types of cancerous cells and limiting harm to normal cells.
  • Molecular Profiling: A method of testing genetic characteristics as well as unique biomarkers of a cancerous tumor.
  • Genomic Profiling: A lab method used to learn about the genetic makeup of a person or a cell type and the way those genes interact among themselves and the environment.
  • Precision Medicine Initiative: The PMI is a $215 million proposed investment in President Obama’s 2016 Budget to increase biomedical research and offer clinicians with new tools to select therapies that will work best in individual patients.

II. Other Types of Trials and Important Definitions

  • Cancer Care Delivery Research:  CCDR examines how social factors, financial systems, organizational structures and processes, health technologies, and healthcare providers and individual behaviors affect cancer outcomes, evaluate and quality of care, cancer care costs, and the health and well-being of cancer patients and survivors.
  • Treatment Trials: Treatment trials are designed to test new ways to treat cancer. To make a treatment standard, it must first go through 3 or 4 clinical trial phases. The early phases ensure the treatment is safe. Later phases reveals, if it works better than the standard treatment.

Phases of Clinical Trials: To standardise a treatment,it must first go through 3 or 4 clinical trial phases. The early phases ensure the treatment is safe. Later phases show if it works better than the standard treatment.The phases are described as I, II, and III.

Phase I Clinical Trial: here, an experimental drug or treatment, initially proven safe for use in animals, is tested in a small group of people (15-30) for the first time. Data are collected on dose, timing, and safety of the treatment. The purpose is to assess its safety and identify side effects.

Phase II Clinical Trial: An experimental drug or treatment is tested in a larger group (100 or less) to offer more detailed information about the safety of the treatment. This usually takes about two years to finish.

Phase III Clinical Trial: Before a test drug or new treatment is approved by the FDA and made available, Phase III trials are conducted on a larger group of people (About 100 to several thousand).Phase III trials are often randomized, in a non-ordered way.

Phase IV Clinical Trial: After approval by FDA and a drug ot treatment is made available to the public, researchers look over its safety, finding more information about a drug or treatment’s risks, benefits, and optimal use. Several hundred to several thousand people participate in Phase IV trials.

Health Services Research: Multidisciplinary research that finds how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care, the quality and cost of health care.

Cancer Prevention Studies: The study of a large group of people to find better ways to prevent people from getting cancer or lower the chances.

Prognostic Studies: This study aims to understand the course, determinants, or probability of a given outcome in cohort.

Observational Studies: The researchers observe groups in which the intervention that each person receives is not controlled by the researchers. These studies tend to be epidemiologic.

Comparative Effectiveness Research: This is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat and monitor health conditions.

We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of proficient candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Different Types of Clinical Research

Different Types of Clinical Research

Different types of clinical trials designs are carried out depending on what the researchers are studying or trying to find out. Below mentioned are descriptions of the various kinds of clinical research.

Treatment Research: This involves an intervention like medication, psychotherapy, new equipments, or new approaches towards surgery or radiation therapy. 

Prevention Research: This looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research might study medicines, vitamins, vaccines, minerals, or changes in lifestyle. 

Diagnostic Research: This refers to the practice of finding better ways to identify a particular disorder or condition. 

Screening Research: This aims to find the best ways to detect disorders or health conditions. 

Quality of Life Research: This explores ways to improve the ease and quality of life for individuals with a chronic illness. 

Genetic studies: Here studies aim to improve the prediction of disorders by identifying and understanding how genes and illnesses might be related. Research in this area might explore ways in which a person’s genes make him/her more or less vulnerable to develop a disorder. This might lead to development of customised treatments based on a patient’s genetic make-up. 

Epidemiological studies: This seeks to identify the causes, patterns, method to control disorders in groups of people. 

Note: Some clinical research is “outpatient,” which means, the participants do not stay overnight at the hospital. Some is “inpatient,” where the participants will have to stay for at least one night in the research centre.

Phases of clinical trials:

To evaluate medications and devices: Role of clinical trial in new drug development or a new treatment procedure

Clinical trials are often conducted in 4 phases. The trials at each phase have a different purpose and help scientists answer different questions. 

  • Phase I trials
    Researchers test a new drug or treatment procedure in a small group of people for the first time. The researchers assess the treatment’s safety, measure a safe dosage range, and identify side effects. 
  • Phase II trials
    The new drug or treatment is given to a larger group of people to see if it is effective and to further assess its safety.
  • Phase III trials
    The novel test drug or treatment procedure is given to large groups of people. Researchers confirm its effectiveness, monitor the side effects, compare it to commonly used treatments, and collect information that will help the experimental drug or treatment procedure to be used safely. 
  • Phase IV trials
    Post-marketing studies are conducted after a treatment is approved for use by the FDA, give additional informations including the treatment or drug’s risks, benefits, and best usage.

For other kinds of clinical research
Many people believes that all clinical research involve testing of new medications or devices. But some studies do not involve testing medications and a person’s regular medications might not be changed. Healthy volunteers are also needed such that researchers can compare their results to results of people with the illness being studied.

Let state with some examples. 

  • A long-term study involving psychological tests or brain scans
  • A genetic study involving blood tests but no changes in medication
  • A study of pedigree that involves talking to family members to learn about their medical needs and respective history.

We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune  are increasing and to meet the current demand of proficient candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Facts Vs Fictions For Clinical Trials

An article was published by the Washington Post detailing how several women were cheated by a so called clinical trial clinic who claimed to restore eyesight, using stem cell treatment for Age Related Macular Degeneration (AMD).

As a result of the procedure the patients lost their eyesight forever. The article was rather a startling wake up call. It details how “unregulated clinics” are coming up all over the world. 

For those of you who don’t know, let me tell you that there is a government website that lists clinical trials, you could visit.  What’s surprising is that this particular clinic got their stem cell ‘treatment’ listed on the website. Though that appears like enough information, in this case there was a warning sign that this was not a clinical trial that was on the up and up. It rather asked the volunteers to pay. If you have never participated in a clinical research study, you must be aware that this is a red flag.

Volunteers are just volunteers; rather they are often paid for their time, but never charged for. To mention, it is not a common knowledge that clinical trials should not have the volunteers cause a cost.  

So what are the warning signs you should look for when thinking to participate or volunteer for a clinical trial?

For starters, it’s best to do your own research. Visit our webpage or social media pages. One benefit is that currently we live in a digital age, and if you don’t have any sort of social media presence that might make you question a research company performing a research study. 

Next step would be your visit to the unit and your interactions with the site staff. All of the site staff is well trained and dedicated to research. That’s not to say the people at the fake clinic were not experts, but while signing up for any research there is lots of information for the volunteers to read and sign.

There are several consent forms to make sure you are making an informed decision about your participation, and outline any potential risks. 

The patients who were misled to believe that the stem cell trial was real, were settled out of court. However, if you take note of some of the potential red flags, bad things never happens to you or someone you know.

An authentic clinical trial centre is dedicated to provide the best care to the volunteers. They build a good relationship with many of the volunteers. If you ever have questions in regards to a clinical study you are being a part, you could reach out to them online or offline. They always look forward for helping out you with queries.

Here we share the link to the original Washington Post article: Three Women Blinded By Unapproved Stem Cell Treatment

We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of good candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Is There Differences Between Drug And Medical Device Trials?

You know that drugs and medical devices are both essential in modern health care, there are times when standard clinical development processes seem to treat medical devices. For instance, medical writers for a contract research organisation who conduct studies of both drugs and devices must learn to interpret a drug-centric guidance document to write an appropriate Clinical Study Report or CSR for each different type of medical device, whether diagnostic, therapeutic or surgical.

The ICH E3 guidance on the structure and subject content of CSRs was created in its current form in 1995 and endorsed by the FDA as a guideline for industry in 1996. According to the FDA Web site, the guidance does recommendations on information that must be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human beings. Thus, the guidance is meant to apply to medical device trials as well as drug studies, at least in cases when a full-dress CSR is desired for a device trial.

How To Adapt A Drug-Centric Guidance for Clinical Study Reports

Besides the official position which says the same guidelines apply to CSRs for drugs and medical devices, a medical writer who is writing a CSR for a device trial quickly encounters several questions. The word “device” don’t appear anywhere in the main E3 guidance, and the report structure that it outlines is clearly focused on studies of the efficacy and safety of drugs. The text makes general mentions of the “investigational product,” but nonetheless includes sections for such topics as drug concentration measurements, drug interactions, and so forth.

Medical writers preparing CSRs for products like in vitro diagnostics (IVDs), which fall under the FDA’s device regulations, quickly encounter challenges in using the ICH E3 guideline as the template for an IVD CSR.

This issue has been recognized by the ICH and is addressed in their supplement Questions & Answers document for E3. Mentioned, what are the options for submission of data for topics like… devices; the short answer from the ICH is: adapt. They reply, saying it is appropriate to create new headings in the CSR and new Appendices for these topics. The Guideline offers for and focuses on Efficacy and Safety variables known at the time. Other topics must be well referenced in the CSR body and clearly identified in the Table of Contents.

To Build A Template Library for Device CSRs

The result is that the details of the structure of device CSRs aren’t standardized as those for drug research, and there is divergence in their format, write-up, and numbering. The differences among device trials make it difficult to create a single, one-size-fits-all CSR template for devices in cases when a full CSR is desired.

An IVD study that uses non-intrusive swab samples, for example, might collect only minimal safety information and have no expected adverse events, while a surgically implanted device might need presentation of a detailed safety analysis. After the medical writer or CRO has earned experience with a variety of different types of device trials, it’s easy to build up a library of templates derived from the E3 guidance, but adaptable to diverse circumstances.

Even with a good library of templates to make a choice, it is essential for the medical writer and sponsor to agree on the optimal structure and subject to support a PMA application for each specific device. Now we conclude.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune  are increasing and to meet the current demand of good candidates, you must join institutes with good clinical research training program . If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Clinical Trial Efficiency Improves With An Experienced IRT Team

Clinical Trial Efficiency

With an increase in complexity in protocols and need to increase the cost-effectiveness of studies, the IRT-related decisions play even greater role in ensuring the most appropriate patient randomization and clinical supply strategies.

Gone are the days of using the “tried and true” IRT systems without further consideration of if they meet your protocol requirements. This is where an experienced IRT vendor comes into scene and is extremely helpful. One, who is familiar with the best practices, consists of experts in clinical practices and clinical supplies and with the skills and knowledge to manage complexity and anticipate issues.

While reviewing a clinical protocol, an experienced IRT team would enquire and identify the issues that could have a significant impact on the IRT cost and effectiveness. The IRT team will perform the following:

  • Seek clarification – For instance, if the protocol says there are 10 drug administrations, the number of IRT dispensing visits might or might not be 10 depending on how the study materials are packaged.
  • Recommend ways to lower complexity without affecting study conduct – For instance, there is an easier way to find each subject’s lineage during several re-screenings without creating complicated subject number patterns that indicate the number of times a subject had been re-screened in each part of the study.
  • Make out if the study will benefit from the forecasting of supplies – For instance, are the materials expensive, stored and shipped cold, difficult to manufacture, have short expiry dates, etc.?  Is it a global study with storehouse all over the world, will enrolment be slow, and many more.?
  • Evaluate and plan for post-live protocol design changes and adaptive studies – For instance, these changes could include adding or removing treatment arms, accounting for levels of cohort dose that are not known unless data from a previous cohort are reviewed.

While designing the IRT system, an experienced team would predict clinical and logical challenges and will recommend:

  • Re-supply strategies to use clinical supplies, like predictive strategies and settings or pooling of materials at the study or campaign level.
  • Randomization strategies, like standard, schedule-driven block randomization, or when a minimization algorithm can best meet the objectives for treatment group work.
  • Kit numbering strategies like randomized instead of sequential kit numbers.
  • Visit schedule and visit design strategies to accommodate visit skips, unplanned visits, dosing rules and the handling of visit exceptions, like withdrawal visits when subjects need to be titrated well.

In an attempt to support and maintain a live IRT system, an experienced team will look for trends and provide solutions for unexpected situations, like the following:

  • Managing visit window hard stops, like when they can be overridden.
  • Managing kit substitutions and partial dispensing when sites do not have the needed material types and quantities in their available inventory.
  • Using forced randomization when recruitment is difficult and sites lack the kit types needed for the next treatment group assignment.

At the same time, your IRT product must be able to support the most advanced randomization and supply capabilities, including adaptive solutions and minimization randomization, while minimizing interruptions as the study changes.

The Trident IRT system is a robust and highly configurable system that could meet a wide range of study designs with little customization or no, which includes adaptive study designs. We conclude now.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of good candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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How To Mature your Content Management Strategy to Support Your EMR

How To Mature your Content Management Strategy

While you see many healthcare organizations using document management/imaging (DMI) systems, a good enterprise approach is yet elusive. Many healthcare organizations have started with their clinical content management component of the electronic medical record (EMR) or other basic systems. As these are often confined to simple storage and retrieval, organizations often wind up using multiple niche systems in several departments. These systems usually do not share information with each other, nor with other key health information technology (HIT) applications, creating storage of information.

These silos render it impossible to take a comprehensive approach to content across the organization; as a result they are unable to support a more comprehensive EMR, essential for patient care initiatives. Healthcare organizations must mature their content management solutions such that they have all patient information available when and where it is required from within the EMR itself.

To perform that, they must move from document management to enterprise content management (ECM). While these two terms are often interchangeable, they are quite different approaches:

Document Management/Imaging:  DMI does document storage and retrieval. Many systems are use for converting paper documents to electronic files via scanning. Since their viewers can only handle a few file types, they often can’t manage a wide range of healthcare content. Moreover, accessing documents could be tedious and is usually not integrated with core HIT applications, like the EMR. Without huge, permission-based access, sometimes document viewing cannot be restricted properly, making the system vulnerable to security issues.

DMI systems often have limited scalability in both quantity and user types and documents they could maintain with optimal performance. They lack sophisticated automated workflow features and are at times difficult to integrate with other IT systems. Due to these limitations, healthcare organizations use multiple systems to meet several needs of different departments, creating silos of information and preventing interoperability across the organization.

Enterprise Content Management: ECM offers a single solution for departments and processes across a healthcare organization. True ECM handles any type of unstructured content that includes graphics, paper, emails, videos, photos, forms, clinical content, images, data and electronic feeds.  

It also has good security settings that keep sensitive content, ranging from patient information to employee files, protected from unauthorized reach. Beyond better storage, it also has easy retrieval permiting users to access content as if it came with their key applications like EMRs or ERPs.  Moreover,ECM brings automated workflows, having tasks completed automatically, to the healthcare enterprise, integrate content in your clinical and business processes. 

Content is at the base of many healthcare initiatives that ranges from offering a complete electronic  medical record to recognizing payments sooner in the revenue cycle to creating more efficient business processes in administrative departments. By moving from a document management system to an enterprise content management strategy, healthcare organizations create powerful Collaborative Content Management as dynamic solutions that will help and support strategic initiatives (meet meaningful usage standards, join accountable care organizations (ACOs), support health information exchanges (HIEs), etc.) today and in coming times.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune, in offering the best training in Clinical Research courses.

Clinical research jobs in Pune are increasing and to meet the current demand of good candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in Pune, CRB Tech Solutions is your one stop towards your career goal.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

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Pharmacovigilance Training In Pune

Pharmacovigilance is a method related to making an evaluationt, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.

The roles of pharmacovigilance jobs mainly focuses on serious drug reactions, or ADRs, which are defined as any reaction to a drug which is noxious, unintended and includes lack of efficacy . Medication errors such as overdose, misuse and abuse of drugs as well as drug exposure during both pregnancy and breastfeeding, are also of interest, even without an inappropriate event, because they may result in an adverse drug reaction.

Pharmacovigilance is a technology and actions about the recognition, evaluation, knowing, and protection of negative effects or any other possible drug-related problems. Lately, its issues have been increased to include herbals, blood products, traditional and complementary medicines, biological and medical devices and vaccines.

You need to get trained to ensure drug safety. The Pharmacovigilance training provides solid practical foundations for peopleworking in drug safety and is of benefit to staff working in the clinical research organizations and to a broad range of staff in the clinical research industries and regulatory authorities. The enrolment under this course could be used as a part of the training required for the Drug Safety Surveillance module of the Pharmaceutical Medical Speciality Training (PMST).

Informations received from patients and health-care providers via pharmacovigilance agreements (PVAs), and other sources such as the medical literature; play a critical role in conferring the data necessary for pharmacovigilance to take place.

The topics covered under Pharmacovigilance training include :

  • Drug safety

  • Global regulatory requirements

  • GpvP audit

  • Signaling and risk management

  • Device safety and vigilance

Importance of such training:

The upcoming clinical research sectors need an inspection on novel products and the way they are being produced after the whole process of clinical research being carried out. In many countries, if the authorities are unsatisfied with an inspection then they have powers to seize product, issue sizable fines and even launch criminal proceedings. And a certificate through a training enables you to quickly demonstrate that the staff has undergone an appropriate training and helps gives an idea that your company has appropriate pharmacovigilance systems in place.

Who should apply for the pharmacovigilance training courses?

The trainings are aimed at personnel treat with the safe use of medicines, mainly in developed countries, including those working or are intending to work in the pharmaceutical industries involved in drug development, licensing and surveillance ; the regulatory bodies who are involved in licensing and inspection ; the health service who are involved in drug policy and health policy decision-makers.

In the competition of many organizations CRB Tech Solutions created a good name. We conduct training classes for jobs with good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune. It has earned a good name among the institute of clinical research in Pune,in offering the best training in Clinical Research courses.

We conclude now. Hope you liked the discussion.

Clinical research jobs in Pune are increasing and to meet the current demand of good candidates, you must join institutes with good clinical research training program. If you are looking for clinical research courses in pune , CRB Tech Solutions is your one stop towards your career goal.

We have a name for our good clinical research associate training and placement program.

The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter