Monthly Archives: November 2016

Why We Need Rigorous Study Designs For Rare Disease Clinical Trials

Why We Need Rigorous Study Designs For Rare Disease Clinical Trials

Finally FDA approved Sarepta’s eteplirsen (Exondys 51), doing this, they actually welcomed the Duchenne muscular dystrophy (DMD0 community. Though it was shrouded with some controversies.

Eteplirsen is a gene therapy drug for administration in DMD patients whose dystrophin mutation is manageable by skipping exon 51.It was approved after a thorough study of 12 patients, 4 of whom, received placebo for 24 weeks before being re-randomized to one of two dosages.There were some brow raising questions regarding the use of historical data as a control in the absence of a concurrent placebo arm of the latter part of the study and the efficacy measures used. But finally, Eteplirsen was given approval by the FDA, and though entire the process was taken over by controversy, demonstrated the power for innovations in designing a clinical trial and analytical methods.

Producing High-Quality Data

After this recent approval, and the essentials for novel clinical research in rare drug development, it might be tempting for sponsors to push boundaries such that their drugs comes to market more fast and at cheaper price. The authorities of Food and Drugs says that owing to all controversies over Eteplirsen they must multiply their efforts to propagate the therapeutic development ecosystem to apply methods that would yield high-quality data from the beginning.

Requirements for FDA Approval

There are certain criteria that need to be fulfilled to get FDA approval. This needs evidence of efficacy and clinical utility of a candidate with well accepted standards and research trial design should portray those needs. Considerable flexibility in evidentiary standards of approval has been noted by other authors in the orphan disease space, suggesting a portfolio of design options that might be possible contingent upon the nature of the product and the therapeutic target. Like other therapeutic areas, endpoints must be clearly defined and time points should be clinically practical. Although the use of historical controls can be considered as a component of the review process (like in cancer drug development), patients must be exactly matched and clinical assessments must be standardized across all contributing trial centres.  Statistics must be prospectively designed to account for all time points and dosages, and potential heterogeneity across reference trials.  Studies should be planned such that the protocol is elaborate with the endpoints; in simple words, test what you have specified.

Bringing Innovation to Trial Designs

Many ways novel ideas can be introduced to planning trials while maintaining the standards of scientific excellence.  When you have to design clinical trials for rare disease, this might include getting the most out of early phase studies.  If your access to patients is limited, make sure that every patient enrolled in the study “counts” – that even proof of concept studies are well designed and properly optimized to help lend credence to later phase studies.  Innovation can also be introduced in study design, mainly in early phase research, that mixes endpoints to reduce timelines and streamline outcomes while informing the next stages of drug development.  A classic instance of this is the mixed SAD/MAD studies that includes algorithm or model based methods of dosage escalation for the purposes of defining an operational dose range for subsequent studies.  To include, Worldwide Clinical Trials has been able to use creative designing to shorten the timelines by 4 months.

We conclude the discussion here.

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

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

The Clinical Research review by CRB Tech Solutions will help and guide you in making a clinical research career in this field.

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Top Hurdles For Patient Participation in Clinical Trials

Top Hurdles For Patient Participation in Clinical Trials

Today we dedicate our blog topic to the hurdles that is face during participation of patients as part of clinical research.

Huge amount of money and good amount of time is spent in enrolling patients and hence addressing the concern of the hurdles that is faced must be addressed to increase study chances and reduce failure rates.

So while designing your trial, keep these 4 barriers in mind as an attempt to prevent participant dropout and errors before they become a threat for the success of your trials:

1 Misconception:

To a patient, the clinical trial phases are full of unknowns. The patients should be detailed about the processes otherwise they might be concerned by fear of being a “guinea pig”, odds about placebo, loss of autonomy, or worries about unknown side effects.

Solution:

You need to address these concerns very early during interactions with the participant. Communicate well how each aspect of the trial is important. You should also mention the advantages of participation, like gaining access to expert medical care, knowing more about their condition, and being active players in their own health care.

2 Mistrust:

Try to understand that history saw mistrust in the medical field, mainly when dealing with minor populations.

Solution:

Be transparent with the patient about your actions and this would be helpful because it will identify and explain the study motives. Another way is that you break down if any communication barriers like language or technological literacy.

3 Logistics:

When developing and implementing a clinical trial, be practical with various aspects. In addition to achieve heights for your site staff, ensure to evaluate the trial design from the participant’s view point, like they must have a busy life and they must be considering your trial a priority in their lives. Common logistical hurdles include inability to take leave from work, transportation to and from the research site, how often they need to be present and how far they might need to travel. Whether they have kids or rely on caregivers, this factor can make things complicate in their participation.

Solution:

During the design of your trial, be mindful about what is needed of the participant. Know the barriers and try to address them as much as possible.

4 Costs:

In order to overcome logistical barriers, many patients will spend their own money to participate in a clinical trial. If your participants face delays in the payment process, they might be forced to wait for reimbursement for up to weeks at a time. With this prolonged and slow payment model, participants might be on their next trial visit before being paid for their last visit. This delay might leave the subject feeling undervalued or that the trial is not systematic, which could lead to decline in compliance and participation.

Solution:

As the participants need a variety of accommodations for logistical planning, they might also need a diverse payment options. Giving your subjects a choice on how they would like to be paid increases your site’s dedication to patient’s concern, which increases the chances of a positive experience in clinical trial. Tools like Nimblify’s Participant Payments provide a variety of payment options that could not only decrease your site’s administrative burden, but also offers other effective and diverse payment plans for participants.

Reducing these barriers to participation in a clinical trial can lead to more reliable study data, make your site more patient-centric and provide an overall better participant experience you achieve future success.

We conclude now with this discussion.

Please let us know your opinion and views on EDC and its usage in CDM in the comment section below.

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

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

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

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Clinical Research Industry’s Strategy to Epidemics

Clinical Research Industry’s Strategy to Epidemics

In the field of clinical research mainly epidemic response face many challenges. Clinical research done on global health concerns often needs rapid action, immediate trial start-up and lower standard good clinical practice (GCP), among many other struggles. It’s very difficult to carry out a clinical trial during the course of an epidemic. However, there are measures to overcome these challenges.

In a recent conference of Partnerships in Clinical Trials (PCT) that was held as a part of Boston Biotech Week (BWB), two inspiring presenters shared their story of journeys working to combat infectious diseases, like Ebola and Zika, in 3rd world countries. Both the presenters presented a common idea that the research industry needs to work together to become more prepared for responding an epidemic occurrence of an outbreak.

Collection of right data

Presenter Toni Hoover of Bill & Melinda Gates Foundation said on the power of technology and therapeutic innovations to fight diseases that affects underprivileged individuals. She said that their organization is dedicated to enhancing quality of life worldwide, works with many people to give vaccines and new therapies to people in poor and downtroden communities.

The Foundation and its collaborators in the biotech field are working to collect data required to make informed decisions during an epidemic. Hoover said that the data has the potential to be utilised to predict where the next epidemic might occur, pronouncing that the whole healthcare ecosystem needs to work together to prepare and develop a platform for combatting with epidemics like that of Ebola and Zika. She said that Zika is a perfect example that says the need to think about interventions, but also how preparations can be made with the help of collection of the right data to advice decisions.

Industry transparency must be increased

In the same manner, presenter Trudie Lang of the Global Health Network at the University of Oxford expressed her belief that the clinical research industry must be more prepared to respond in the event of an outbreak.

With reference, Lang shared her experience as a researcher performing an Ebola trial in West Africa. She described the hurry to begin the study and was under immense pressure to complete the trial in 16 week only. Lang said that her team was able to complete the clinical trial at rapid speed, but admitted they were too late. The epidemic already spread fast by the time the trial was complete.

This experience made Lang realise that the research community must be always ready to combat infectious diseases before an epidemic reaches a downward slope, more possibly before an outbreak occurs.

Finally Lang proposed a solution to the current problem by saying that research information must be shared and there should be transparency in clinical research industry.Lang came forward with an argument that sharing clinical research information between groups, plagued areas and regions would enhance the agility of a research enabling faster response to life-threatening diseases.

Fact is that epidemics and global diseases are significan cases for the need of organizational collaboration and information sharing. The two women and their research highlighted many aspects of clinical research that could prevent or help people in their suffering worldwide.

Now we conclude the discussion.

To learn more methods for increased industry efficiency, view our library of resources for clinical research professionals.

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

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

The Clinical Research review by CRB Tech Solutions will help and support you in considering a clinical research career in this field.

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Interview For Pharma Freshers : Tips & Preparations Part II

Interview For Pharma Freshers : Tips & Preparations Part II

Today we continue with the same topic we were discussing in our previous blog post.

Interview tips

The three aspects of the interview process:

  • Pre-Interview Planning
  • Interviewing
  • Following-up

PRE-INTERVIEW PLANNING

This will make you more confident and keep you motivated. Before you start keep a written or computerized list:

  • Date resume was sent
  • Name of company
  • Name of person you sent it to
  • Address
  • Phone
  • Date and time of interview
  • Results of interview
  • Second interview
  • When you sent a thank you letter or note

You need to find about the company thoroughly, which is very essential but it is often neglected. Try finding out the following information:

  • Products or services
  • Company history
  • Number of employees
  • Business methods
  • Distribution methods
  • Organizational structure
  • Clients or customers -Locations
  • Reputation
  • Philosophy
  • Industry standing/ Sales or activity volume
  • Prospects for company growth

INTERVIEWING

You need to relax and think about all of your skills, accomplishments, and abilities. You should know your strength and weakness. You need to make a resume that would say everything about in details and must be appealing.

Resume

  • Be honest.
  • You need to quantify your achievements with figures and percentages
  • You must think in terms of increasing productivity, decreasing costs, and increasing profit for the company.
  • Try to appear relaxed and alert
  • Be friendly and an enthusiast.
  • Always dress in your formals and be calm in your look.
  • First impressions counts.
  • Groom yourself well.
  • Sit comfortably and with good poise.
  • Ask questions. If you want to clarity certain aspects of the job.
  • Don;’t ask about paid holidays and vacations unless the job is offered
  • Carry extra resumes and references with you.
  • No fancy jewelry please.
  • Be polite.
  • Show a can-do and positive attitude.
  • If asked general questions, answer in terms of your professional abilities and experiences.
  • Never, never criticise former employers.
  • Have good posture and direct eye contact.
  • Give a firm handshake before and after the interview
  • Speak clearly in a firm, confident, and not too loud voice
  • Smile, when appropriate
  • Try to relax
  • Give specific answers to all questions. Don’t be vague.
  • Thanks the interviewer.
  • If you are really keen for the job, tell the interviewer again before you take your leave.

EMPLOYERS INDICATE THAT YOU CAN HURT YOUR CHANCES OF GETTTNG A JOB BY :

  • Poor career plans
  • Under qualified for the position
  • Communication not proper
  • Unsatisfactory evidences of achievement
  • Fail to research the company
  • Displaying a lack of interest in the organization
  • Unwillingness to relocate
  • Appearing more interested in money and benefits than anything else
  • Fail to follow-up post interview

THE GOLDEN RULE OF INTERVIEWING:

Be yourself, know yourself, and sell yourself.

Employers are looking for someone who can contribute to the buisiness by:

  1. Making Money
  2. Saving Money
  3. Saving Time

So keep it in mind.

WE conclude the discussion now. You have to prepare by your own and crack your interview confidently.The above tips are very essential to keep in mind. Good luck!

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

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

The Clinical Research review by CRB Tech Solutions will help and guide you in making a clinical research career in this field.

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Interview For Pharma Freshers : Tips & Preparations

Interview For Pharma Freshers : Tips & Preparations

Today we write this blog topic keeping in mind the Phrama candidates who are seeking job and the trouble they find in preparing and coming out bright in respective interviews.

Let us share a secret! Yessss Here if studies to be believed then most of the interviewers were never trained before to conduct interviews. Even the managers are anxious, confused and stressed like the job seekers. This blog will help you in directing how to avoid from being into stressful situations before an interview.

What are the pharma companies and the CROs are looking for?

  • Your confidence
  • How you play in a team
  • How you focus and pay attention to minute details
  • How good you in handling the most difficult questions
  • You attitude and body language.
  • How you manage stress

Do’s and don’ts before attending interview

Do research about the interviewing pharma company or CRO?

  • Main areas where they work.
  • How your skills match with the company’s area of work

Punctuality and discipline

They are the key factors that decide candidate’s fate. Never be late for the interview, be there ahead of time.

First impression matters

Take advantage of this view and no matter how anxious you are, wear a smile that will show how confident you are and your self-esteem. Another reason to keep smiling because research says that people who smiles don’t get stressed.

Handshake

A firm handshake with interviewer is a must, by using the whole hand. Don’t be loose or too tough at the hand shake, either has negative message, so be casual an firm with confidence.

Attitude

The moment you enter the interview room, simply don’t go and sit down. Wait for a few seconds until the interviewer tells you to have a chair. If the interviewer doesn’t offer, then ask politely if you could sit down. Do not put anything on the interviewer’s desk

Interview questions

All interview questions are not the same. So you need to answer as they come. Some question needs precise answer and a few needs elaboration.

To mention there are 4 types of questions:

Straightforward questions

  • Tell us about yourself.
  • What are your strengths?
  • What accomplishments your are proud of?
  • What of your skills you have that would be good for this company?
  • Why should we hire you?

Questions behind questions

  • What do you know about this company?
  • Where do you see yourself 5 years from now?
  • Why you left your last job?

Stress questions

  • Tell us about your greatest failure
  • Tell us about your greatest weakness

Questions you need to or can ask the employer

  • What is the ideal candidate for this profile?
  • What would be my role in the first year of employment?
  • What are the company’s new products or services that is going to launch?
  • What do you like about working at the company?
  • Can you suggest how I can personally contribute to drive this business to the competitive edge?

We conclude the discussion now. What we discussed are only a few questions that might come your way. You have to prepare your own notes for the above mentioned questions and crack your interview confidently. Good luck!

To be contd.

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

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

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

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21 Trends for Nurse Practitioners in 2016 Part III

21 Trends for Nurse Practitioners in 2016 Part III

Today we continue with this blog topic we started and conclude the discussion that we started a few days back, what is making nurse practitioners trending in 2016.

Population Health

The term maninly includes geographic populations such as communities or countries but could also be ethnic groups. The actual goal of population health initiatives is to understand that every group has a unique need and create target friendly interventions to look into the needs. If reports are to believe then this collaboration is really being fruitful and significant.dicalechnolog

Electronic Medical Records (EMR)

A report stated that by December 2015, the EMR market was estimated to be worth $23 billion with more than 400 unique vendors. The report made the top earning EMR companies happy,but clinicians were not.

In 2016, the EMR market players might shrink. With the need of smaller medical practices those practices will take upon the larger organization’s EMR. This attempt by healthcare groups will gradually squeeze out smaller EMR vendors, and the market will incline more towards the EMR giants like Epic and Cerner.

Mobile Health(mHealth)

mHealth is a rising trend currently in health sector. Sometimes called connected health, it is defined as the generation, aggregation, and dissemination of health information via mobile devices.Other trends in the mobile health market include anthe alternate utility of helpful smartphone apps. To mention, health and fitness apps grew 87% faster than the overall app industry in 2014. This rise has attracted major technology companies like Apple and Google to introduce their own mobile health products.

The Cloud

As per an international survey, 83% of healthcare officials are currently using cloud services for human resources applications,clinical information and disaster recovery. Practically cloud-based softwares in healthcare lessen the costs by limiting number of servers a hospital needs to purchase.

A huge challenge in clinical trials has been data storage and currently, 30% of the world’s computer capacity is used to archive medical images including CT scans, x-rays and angiograms. Cloud helps maintain data with an exponential capacity throughout the entire lives.

Telemedicine

Currently with an attempt of digitalization and increased public access to WiFi, and a essence of connectivity, telemedicine is fast emerging another booming industry in healthcare technology. Repots suggest that telemedicine is safe and cost effective.

Ingestibles, Implantables, & Sensors

In the years 2014 and 2015 health technology wearables made rounds in headlines, and this year it took to more about ingestibles, implantables, and sensors. Google recently announced their smart contact lenses that can monitors a wearer’s blood sugar levels in real time.

Decision Support

Yes we shall mention aboyt IBM’s Watson, named after the company’s first CEO, it is a highly intelligent computer capable of answering complex questions using natural language processing. It is to believe that the future for Watson Health is bright.

The Internet of Things

As it relates to the healthcare sector, it attracted a lot of attention in 2015 when Market Research reported and predicted that this industry would be worth $117 billion by 2020. Abbreviated as IoT, is said to have all objects connected and collects data. The value of IoT can be ascertained from the correlation between all the things and the data created by them.

The IoT helps nurse practitioners to allow theirs patient’s to recover at home yet keeping a watch ober them and monitoring their health status from a distance making use of products like BodyGuardian Remote Monitoring System.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections below.

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

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

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

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21 Trends for Nurse Practitioners in 2016 Part II

21 Trends for Nurse Practitioners in 2016 Part II

Today we continue with the blog topic we started a few days back and shall discuss some other points that is making nurse practitioners trending in 2016.

Here I’m discussing a few more and the many more shall be covered in our upcoming articles.

Integrated Care

In 2015, great initiatives were taken in integrating primary care and psychiatric care. The common venture of both the Mental Health Parity and Addiction Equity Act and the Affordable Care Act created the perfect blend to help integration. The new payment models reward healthcare providers for improving patient outcomes while making an effort in reducing overall costs and research. This is what integrations can achieve.

Empowered Patients

The thoughts and views of patients are given a better and more priorities. Now patients can make of use the internet to compare hospitals and select the one with the best clinical prospects, safety measures, and competitive costs. Patients are actively making use of this benefit and choose their healthcare facilities and providers wisely. Thus the well informed patient has become an empowered patient.

Wellness & Employee Health

Now more and more insurance payers and large organizations seek to bear health care costs under the Affordable Care Act. Though similar programs existed earlier, they have currently begun to gather considerable traction. Businesses are now offering their employees free gym memberships, free health screenings, massages, mid-day yoga breaks, smoking cessation classes and weight loss resources.

Bundled Payments

In the year 2015, the Centers for Medicare and Medicare Services announced a number of payment reform models in which they proposed to authorise bundled payments for total hip and total knee replacement in 75 different geographic areas across the region.

This proposal came as a shock for a few medical groups because for the first time, the concept of bundled payments would become a requirement and not voluntary. As 2016 progresses, let’s keep a watch on the outcomes and can anticipate more unique payment models yet to be announced.

ICD-10

The US ultimately implemented the International Classification of Diseases, 10th Edition (ICD-10) on October 1, 2015, to become the last modern healthcare system in the world to adopt this more effective coding system. Originally started by the World Health Organization (WHO) in 1992, ICD-10 designed a coding system that classifies diseases and other health issues such that diagnostic information can be easily stored and retrieved.

Greater Accountability

Now an era of accountable care has begun with the already existing healthcare. Hospitals are now accountable for their patient outcomes and there is forming of Accountable Care Organizations. It’s mandatory for hospitals to demonstrate to the public exactly how and how well they are implementing evidence-based practices. They must also submit reports to the federal government, which then becomes open to the public.

With time, CMS is becoming more and stricter regarding the delivery of accountable care. Those organizations that fail to meet CMS’s criteria are subjected to reimbursement reductions. In the coming years, CMS is likely to increase the penalties and holding the hospitals more accountable for delivering high-quality care.

Now we conclude here. Hope the discussion is giving the right and precise information to you.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections below.

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

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

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

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How Scalable Is Your Clinical Trial Payments System

How Scalable Is Your Clinical Trial Payments System

Today in this blog topic we shall discuss about ClinPay a payment solution initiated by Bioclinica and is being very helpful to the Clinical Research Organisations worldwide.

How Scalable Is Your Clinical Trial Payments System

Bioclinica came up with this alternate payment option to help CROs that have outgrown their site payment systems. Whether they’re using manual home-grown system or spreadsheets with the increase in number of clinical trials they’re conducting, the CROs often find it difficult and a realisation that the current systems are not sufficient.

It is very important to maintain accurate and timely payments and as a result, it’s important to choose a payments solution that is scalable, in other words it should be an automatic one as opposed to the manual. ClinPay is a part of the suite of Bioclinica products designed to automate the entire financial lifecycle of global clinical trials, which includes contract management, contract term translation, payments, accounting and reporting functionality. ClinPay can significantly reduce workload and operational costs, make an access to clinical research payment information, and enable multi-currency management. To mention that ClinPay is very much data-driven and automatically evaluates incoming data against contract terms in order to determine a wide variety of payments, which says that no matter how vast your study is, how many sites you possess or how you payment terms, ClinPay can scale to fit your needs.

Let’s share an example for a big CRO who has found success after switching from the manual system to an automated. A top CRO grew significantly within a span of short period of time, making the investigator payments process a significant and admin-intensive challenge. To mention the 100 team members were given the task to hand just grant payments. The CRO does 350 to 400 global trials at a given time, and hence was becoming difficult to make payments to sites in time and in accurate ways. As a result, the CRO was flown with complaint mails and messages from sites about payments, which lead to bad relationships with the sites as well as sponsors. The CRO realised that their manual payments model wasn’t automatic, and they needed to do the technology way and find a technical solution to keep pace with their growth.

After discussing and reviewing many good financial management solutions, the CRO decided to give ClinPay a try because it was the only end-to-end solution that could manage all the unique challenges and characteristics of a clinical process. The CRO was also particularly interested in ClinPay’s ability to make global payments and knowing of country-specific requirements. Additionally, the CRO wanted to use ClinPay to pay their sites accurately and on time as well as achieve a significant amount of financial savings. Finally, the CRO wanted to use ClinPay to enhance efficiency with their clinical research team so that team members could focus more on the trials and less on site payments.

Now the story is that by using ClinPay, the CRO has well organised their process, gained remarkable efficiencies and allowed many of their team members to focus on more vital tasks.

We conclude.

Please let us know your opinion in comment section below. Readers’ opinions are valuable! A good discussion is the gateway to many innovations and ideas.

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

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

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

Related Posts:

1) Why Clinical Trials Are Very Much Useful Through Mobiles?

2) Clinical Trials and Its 4 Stages for New Medications

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Changes Required In Clinical Trial Of Alzheimers Disease

Changes Required In Clinical Trial Of Alzheimer’s Disease.
Changes Required In Clinical Trial Of Alzheimers DiseaseToday’s blog topic is about rectifying screen failure and enhancing recruitment rates in clinical trials of Alzheimer’s Disease.

Failures in Alzheimer’s Disease (AD) clinical research have many factors which includes an inadequate understanding of mechanisms of action and poor target engagement; poor study design, wrong stage of AD matched to a particular drug, limited statistical power of endpoint measures, and inclusion of ineligible participants, also contribute.

Proper approach to study design and optimization of recruitment/screen failure rates are proving increasingly significant as the field focuses on putative disease-modifying agents and patients that are early in the disease spectrum.

Studies of patient eligibility found that only 10–27% of potential participants are trial-eligible. That is really a lees count. To mention, few AD patients are aware of research opportunities and many are unable or not willing to take role. Many aged people lives alone and might not have access to a caregiver who can help them in participation.

Truly speaking what is imperative to success of an AD trial is not one but two participants, i.e. the patient and a study partner, and the involvement of this dyad is essential.

To choose the right patient for a study and exactly translating their medical data into a protocol-specific entry criteria, stirs major challenges. Other hurdles include medical co morbidities, use of prescribed and OTC medications, and behavioural complications which could all be exclusive.

Improving Screen Failure For AD Clinical Research

The development of symptomatic treatment in mild to moderate AD fals between the ranges of 15-35%. This range is manageable, but very common for trials to fail twice the rates in early AD populations. To overcome these, a gradual approach to patient’s eligibility factors might be utilized, that takes into account all known and estimated screening variables.

It is quite difficult to lower failure rates caused by unpredictable factors like amyloid level on CSF, safety brain MRI indicating ARIA and amyloid-PET.

One promising technique utilizes statistical tools that predict the presence of amyloid/tau or even the eventual diagnostic conversion to AD. Conventional techniques that involve using multiple regression analyses to predict the presence or absence of beta amyloid or tau on imaging or in CSF, based on scores on previously obtained and easy to acquire screening measures such as cognitive test scores, demographics,genetic status, clinical signs/symptoms and structural MRI findings.

Another method has been suggested to minimize the clinical trial costs without making compromising with statistical power. Utilizing an adaptive design for data acquisition exploits harmonic analysis of a band-limited signal graphically, whose node corresponds to participants with the goal of fully recovering a multivariate signal on the nodes, given the full set of lower-cost features and a partial set of more expensive measurements.

Analytical techniques offer the opportunity to predict which subjects will qualify for study participation in an adaptive manner, with each additional piece of screening information enhances the success of final predictions based on biomarkers. These methods and an increased familiarity of patient clinical status and the use of a hierarchical approach to screening should help to reduce screen failure rates, improving overall recruitment rates in these notoriously difficult-to-enrol trials.

We conclude here.

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

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

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

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A Dilemma For Big Pharma Companies : CNS Drugs

A dilemma for big pharma companies : CNS Drugs

The central nervous system (CNS) is the most complicated area of clinical research. And currently the big pharma companies are keen to invest in this therapeutic area. But the R&D spends have not yet got rewarded with the desired results. R&D in this area is risky and chances of approving the drugs by the regulatory board are very slim. Hence big pharma companies are at the risk of major losses.

The budget of clinical research for developing a CNS drug versus a cardiovascular drug is 30 percent higher and the chances of a CNS drug reaching a great status in the market is about 50 percent lower.

Research and development by big pharma companies in area of diseases like depression, anxiety, schizophrenia, Alzheimer’s, Parkinson’s and stroke have invited the risks of heavy investments but very less guarantee of success.

The big companies concluded that the risks associated with CNS drug development are very high—so are they justified?

Challenges Facing CNS Drug Development

External pressures have created trouble for the pharma industry’s efforts to address CNS disorders like the active “anti-psychiatry” movement made up of organisations, politicians, religious groups and layman who does not believe the importance of psychiatric treatment.

Moreover there are also the internal pressures. For instance only 8.2% of CNS drug candidates become available for clinical use, compared with 15% of other drugs. Phase II and III of clinical trials and also the regulatory approval; all takes much longer for CNS drugs compared to other therapeutic drugs. Some CNS drugs might take 18 long years from preclinical work to marketing, and clinical research organizations rarely take the benefits of available regulatory tools like Priority Review and Fast Track designation.

Phase III failures

As per reports, most CNS R&D losses of recent years are due to the fact that the majority (4 out of 5) of CNS leads fail the most crucial and expensive phase III stage of clinical trials. And reasons are numerous that includes strict board regulations for CNS disorders to insufficient understanding of the facts underlying brain disease.

What Clinical Research Organizations (CROs) Can Do?

To mention, the figures say that CNS disorder – patients outnumber that cardiovascular disorders ones and with increase in population, the numbers with CNS disorders are increasing. To address this need, there are some ways to enhance the speed of CNS drug development like; implementing proof-of-concept studies, orchestrating studies with a singular drug development team rather than by handing off studies phase by phase, and embracing open, dose-ranging trials followed by moves to a small sample, randomized clinical trial before the move to Phase III. The idea to co-develop CNS drugs with publically sponsored research institutions can also lessen the known risks involved in the development process of CNS drug.

Effective CNS drugs can lessen patient suffering, prolong longevity, improve life-quality and address public health concerns—so it’s essential for all of involved in the drug development process of CNS to look for innovative approaches in bringing these drugs from lab to the market.

We conclude here.

The fact is that disorder associated with central nervous system need to be seriously considered and effective measures in their development process should be initiated.

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