How To Create A Request for Proposal For Clinical Trial Services

If you’re searching a contract research organization (CRO) to offer clinical trial services, it’s that you’ll need to create a request for proposal (RFP). In the world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs is very challenging. The good news is that with a little planning and time, you could create RFPs that will lower inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are 5 tips for creating RFPs that will help you do the right comparison and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

  1. Give background information on your program. Information about other clinical studies completed or in progress, results of preclinical work and even funding and marketing plans can provide context that will help a CRO understand your requirements and give you a proposal that would best address your concerns.
  2. Give a protocol or protocol synopsis.  Details about the study, like number of clinical trial sites, number of subjects, and type and frequency of procedures and assessments are important cost drivers and providing them will help ensure a more accurate proposal.  Also, an experienced CRO should also be able to make valuable recommendations based on your protocol.
  3. Give detailed RFP information to get consistent costs. Be precise. Some examples might include:
    • Project specifications
    • Project timelines
    • Responsibilities
  4. Give additional details. The more details you provide, the better it is.  It’s also good to ask the CRO to provide with recommendations. You can tell a lot about a CRO by the recommendations they make and how they make them.

However, if you ask CROs to make recommendations be prepared for potential inconsistencies in the assumptions made and pricing offered between different CROs. The following are listed some additional details that might be helpful to bidders:

    • Suggest site locations if you have already determined which sites you want to use.  If you aren’t sure, ask for recommendations based on your target enrolment and timelines.
    • If you’ve already determined which sites you’ll be using, it is helpful to know whether they will use a central lab or local lab and also will they use a local or central IRB. This can have an impact on timelines and costs.
    • Make note of any additional vendors you need such as specialty labs, Electronic Patient Reported Outcomes (ePRO), translations, meeting planners, or imaging services.
    • To know if using paper or EDC? What data output you prefer. Based on the regulatory strategy of FDA’s guidance, new studies must be submitted in CDISC format.
    • If you are planning an interim analyses or need support for a DSMB, ensure to include this information.
    • What are your plans for clinical supplies and distribution?
    • Are you willing in risk-based monitoring strategies? If so, provide this information in your RFP.
    • Do you want the CRO to be responsible for the TMF? If so, enquire if they use an eTMF and which one.
    • If you know you want to use specific vendors, ensure to include that information.
  1. Other items to request from CROs:
    • Project team CVs including the project manager, lead CRA, lead data manager, medical monitor, and lead statistician
    • Summary of team therapeutic experience and experience running similar trials
    • Relevant company information

We conclude now. Hope you liked the discussion.

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.

CRB Tech offers one of the best clinical trial and consulting services. It is also taking initiative in pharmaceutical product development. Several organisation carry out clinical trials in india and they have projects in various clinical trials phases

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 and also offers clinical trial services.

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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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Introduction to Clinical Data Management

Clinical data management (CDM) is a critical phase in clinical research, which helps in generation of high-quality, reliable, and statistically sound data from clinical trials.

Clinical data management assures collection, integration and availability of data at appropriate quality and cost.

Clinical Data Management is a process of handling data from clinical trials and researches. The inherent goal of any clinical data management system is to produce and maintain quality data.

There are several steps in CDM, as mentioned below:

  1. Source data are produced. Common examples of source data are clinical site medical records, lab results, and patient diaries.
  2. If paper Case Report Forms (CRFs) are being used, the clinical site records are transcribed onto the CRFs.
  3. Data are entered into the clinical trial database. Electronic CRFs (eCRFs) permits data to be entered directly into the database from source documents. Data from pCRFs are often entered twice and restored in order to lower the error rate.
  4. The data are checked for quality, accuracy, and completeness and problems are solved. This often involves queries to the clinical site. The database is securely locked, when the data are considered final.
  5. The data are needed for reporting and analysis. Tables, listings, and figures are produced.
  6. The data are analyzed, and the analysis results are reported. When significant results are found, this step may result in the generation of additional tables, listings, or figures.
  7. The database and other study data are archived.

N.B. Clinical data is a good resource for most health and medical research. Clinical data is either collected during the course of ongoing patient care or as a part of a formal clinical trial program.

These steps are not strictly ordered. For instance, it is common in longer studies to generate intermediate discrepancies and listings periodically to identify problems that need correction before study completion.

Q: What are the elements of data quality?
A: The FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations defines the fundamental elements of data quality for both paper and electronic records by “ALCOA”:

  • Attributable: The source of the data is known.
  • Legible: The data could be read and comprehend to people.
  • Contemporaneous: The data are recorded on yield.
  • Original: The data are the first recording from the primary source.
  • Accurate: The data are correct.

The quality data also needs at least three other aspects:

  • Data are to be readily available, transmissible, and storable.
  • Data are complete and unbiased.
  • Data are in a format that is consistent and compliant with or readily transformable to accepted standards.

21 CFR 11 details the rules that are needed to insure that electronic records are reliable. Proper implementation of 21 CFR 11 helps ensure that the Attributable, Legible, Original, and Accurate aspects of the ALCOA standard are met.

Validation In Clinical Data Management

Validation of clinical data management programs and procedures is needed to find that clinical data management standards are met.

We conclude now. Hope you liked the discussion.

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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Must You Invest In HIV Prevention For People Who Inject Drugs?

People who inject drugs constitute less than 1 percent of the U.S. adult population. But approx 10 percent of the new HIV infections in this country are due to injection drug usage.

So it stands to reason that focusing on HIV interventions for injection drug users could have tremendous public health benefits, Stanford researchers contend in a research study published in the Annals of Internal Medicine.

Cora Bernard, a Stanford graduate student in management science and engineering and lead author of the paper, explains that we know that the health benefits of interventions for high-risk individuals extend to the U.S. population. And with the recent rise in opiate drug use in the U.S. and HIV outbreaks in places like Scott County, Indiana, it’s increasingly important to invest in prevention programs that are both effective and cost-effective.

The authors used new clinical data to determine that pre-exposure HIV prophylaxis, mixed with frequent screening and prompt treatment for those who do become infected, could lower the HIV burden among those who inject drugs.

And that could provide a public health benefit for all Americans. 

However, prescription drug costs in the US are among the highest in the world, making this form of intervention quite expensive.

Moreoevr, the cost of the HIV screening and assessment for adverse effects every three months and supervising for toxicities every six months. To this, Bernard stated that the kind of cost scales rapid. Although you’d be preventing the downstream costs of some infections, providing pre-exposure prophylaxis to 25 percent of HIV-negative people who inject drugs for just one year would require an upfront investment of over $3 billion.

Many trials shown that daily oral pre-exposure prophylaxis or taking HIV medications to lower the chance of infection could prevent transmission of HIV. This prompted the Centers for Disease Control and Prevention to revise its clinical practice guidelines in 2014 to recommend this treatment be considered for any adult who injected drugs within the previous six months, shared needles, enrolled in drug dependence treatment, or was at increased risk for sexual transmission.

To achieve these benefits, however, costs $253,000 per quality-adjusted life year. In comparison, needle-syringe exchange programs cost $4,500 to $34,000 per quality-adjusted life year.

The authors concluded that frequent screening and pre-exposure prophylaxis, as well as prompt treatment for those who become infected, could lower the HIV burden among people who inject drugs and provide substantial public health benefits. They also found that enrolling 25 percent of HIV-negative people who inject drugs in a program that combined pre-exposure prophylaxis, screening and antiretroviral drugs would lower the HIV burden in the US.

But it is expensive.

Cost effectiveness is one of the many considerations for policymakers, who must also evaluate the ethical aspects of an HIV prevention program for a population with generally low access to health services.

We conclude now. Hope you liked the discussion.

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 Many Of You Are Monitoring Blood Pressure Endpoints for Clinical Trials?

At several centres, occasionally scrutiny is done to check blood pressure as part of the cardiac safety assessment for compounds in making. The assess of BP responses to drugs being developed for non-cardiovascular indications is increased public awareness and regulatory measures, evidenced by formal scientific discussions at prominent meetings by the Cardiac Safety Research Consortium (CSRC) on this topic.

While designing a study that is aimed at measuring the “off-target” BP effect of a compound, there are a number of factors to keep in mind. Here we enlist 3 key considerations for accurately defining the off-target BP effect and maximizing the potential of your blood pressure cardiac safety study.

  1. Does change in blood pressure relate to compound concentration?
    It is important to find whether an off-target BP signal is related to increasing drug concentrations or if it is independent of drug concentration. To determine whether the observed change in BP displays dose dependency with your compound provides valuable clinical information. Assessing the concentration effect on BP signal within a SAD or MAD study in the early phase development of a compound can be beneficial prior to moving into a phase II, patient-based population.
  1. Blood pressure signals for short and long term exposure to a test compound.
    After establishing a comprehensive BP profile of a compound provides valuable information from a clinical management and regulatory perspective.  When evaluating a study compound, it is essential to determine if the BP response reaches a plateau or continues to increase as a function of extended exposure. Furthermore, from a safety perspective it might be important to understand what occurs to the BP upon cessation of drug treatment.
  2. What are the options available for evaluating the BP changes?
    When it comes to observing BP, there are several options for the sponsor to look out based on a number of parameters including clinical study phase, patient population, therapeutic indication and an understanding of BP response profiles obtained during early compound development.
    The common BP measurement and monitoring options include:

    • 24-hour Ambulatory BP Monitoring. ABPM is a key diagnostic technology, helping surrogate endpoint data describing BP changes over 24 hour time periods. Constant supervision enables evaluation across circadian rhythms, providing a more comprehensive analysis of BP changes.
    • Automated office BP monitoring. The benefits of using automated BP monitoring include calibration and standardization of equipment across study sites and removal of variability resulting from human/auscultator bias.
    • Remote home BP monitoring. Telemonitoring offers a means of electronically transferring study participant, self-monitored BP data to a central unit, lowering the number of patient visits and increasing patient compliance for a study.

The practice of BP monitoring in clinical trials is gaining perspective at different pharmaceutical sponsors who has been greatly involved in addressing and navigating approaches to defining an off-target BP signal for a test compound.

We conclude now. Hope you liked the discussion.

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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Some Tips On How to Lower the Effects of Turnover At Your Clinical Research Centre

Are you facing challenge with hiring and retaining top talent? It is a struggle most clinical research centres encounter. Turnover can cost as much as $25,000, and a bad hire can lose a site up to 40 percent of productivity.

The everyday struggles to take in trial subjects, perform quality trials and maintain a balanced process can put undue stress on a site’s team and culture, causing burnout, low morale and, eventually, turnover. Low morale could be contagious, leading to the destruction of a team and an overall decrease in production and revenue.

On-boarding new staff and training existing staff on protocols can be time consuming, and many sites simply do not have the dedicated resources to maintain an internal trainer. Thus, sites are relying on their top employees and revenue producers to mentor and train. So, the question is how to avoid and lower the effects of turnover?

Assess your hiring practices

Looking into your current process could be the first step in hiring the correct talent. Most sites have a traditional hiring process of recruiting talent from their websites and career search engines, followed by a review of the candidate’s previous employers, roles and responsibilities and education.

But, do this really give an idea of how well the candidate works and fits your team? 20 years of experience really don’t mean they are the best candidate over someone with lesser years of experience.

Thinking different and using behavioural interviewing techniques could help identify talent that fits your team and your current requirements. Focus on a few key competencies could help you identify the right candidate; previous behaviours are an excellent indicator of future behaviour and, thus, help to assess if the candidate may be able to work within the need you are looking for.

Engage the current employees

In order to retain top talent, a site must continuously engage their employees to make sure they are challenging them, providing opportunities for professional growth, and motivating them to work at the top of their scope.

To mentor and team build opportunities could be effective ways to keep talent engaged. Imagine your team coming to work every day happy and empowered, this could happen if you build the right team. There will be some ups and downs in the workplace; the key is to minimize the downs in order to keep employees engaged and support the success of each other and the site.

There are several online sources from which you could earn ideas for you to develop behavioural interview questions customised for your site’s requirements, and also tips to help you determine what differentiates your top candidates.

Last but not the least, discuss among the management team how to engage your current employees in order to help lower the turnover.

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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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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