Tag Archives: Clinical research

Clinical Research for Health Checkups

Clinical Research for Health Checkups

Fit and Fine

The issue to be dealt is about the medicines which are reactive or which have side effects. If you fall sick or get some hurt or swelling you go to the doctor for check up and get some medicines if it is cured then no problem if not then it may lead or side effects. So this is all about such reactive medicines and either preventing disease or curing it at its first sight of symptom by Health Checkups.

“Respectable period for guest and medicine is only three days”

There is no possibility of everything being prevented but you can reduce the risk factor. Heart disease, for example, is the leading monster to end ones precious life in general. And the reason is inactivity, high blood cholesterol, obesity etc. But many people don’t realize the risks until they have a heart attack. We often ignore warning signs, and we don’t always get regular check-ups (sometimes because we can’t afford them). It is believed that within the next 10 years or so, wellness programs will be considered an integral part of most organizations for Health Checkups. They’ll even offer incentives for employees who participate and meet their goals and penalize those who don’t.

Health in your hands

Clinical-Research-for-Health-Checkups03

There is a prediction about how we take care of your health. Well there are various apps and gadgets for checkups say your blood pressure, Heart beat and technologies like scales that measure weight and body fat and send them via WiFi to a Web site, or an armband that measures blood pressure and plugs into an I-Phone, will be more common. So we will be sending such reports to reputed doctors who will be online receiving it any time at your service. Even there is a further advancement in future technology for health that silicon chips will be attached to your mirror in bathroom and when you blow into it your saliva droplets will let them know about your gene and whether you are in good health or not? It is an awesome Health Checkup scheme

Clinical-Research-for-Health-Checkups02silicon chip

Check your warranty

Well there are some diseases which are hereditary there might be a possibility or risk factor for you to get up with such disorders so if you want o have a checkup which will cost money and time the it will be hectic for you to deal with then so for this reason writing, getting your individual genetic code mapped costs around $100 to map your genes and place them on a CD. And it will be a part and parcel of your life. Your doctor will take a saliva or blood sample and almost instantaneously have a sort of owner’s manual for your body. Known as genomic medicine, this practice would allow doctors to both treat illnesses based on your genes and work to prevent you from getting sick in the first place.
Clinical-Research-for-Health-Checkups01

Related Topics:

1)Requirement of Clinical Research Associate

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

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How Clinical Research Management Can Help You?

A scientific analysis manager conducts analysis, investigations and tests of protocol subjects and participants. Their responsibilities consist of collecting data and monitoring the results of the scientific tests. Clinical analysis planners also collaborate with other medical managers in the implementation of scientific tests and the recruitment process of medical trial participants.

Work Experience

To become a scientific analysis manager, applicants for these positions should have prior encounter as scientific analysis experts. Understanding the scientific analysis process and participating in scientific tests are important attributes that companies may need applicants for the job to have. The degree of scientific analysis encounter needed to qualify for a job as a scientific analysis manager is determined by the companies. Some companies may need only one to two years of scientific analysis encounter, while other companies pursue individuals with additional years of encounter.

College Education

Many companies may seek applicants for the scientific analysis manager place who possess an associate’s or bachelor’s degree in scientific analysis. Having a degree in scientific analysis, coupled with less than one to two years of expertise in scientific analysis, may meet adequate minimum qualifications with some companies.

Because scientific analysis planners prioritize and oversee the development and implementation of scientific analysis tests, many companies need them to be licensed as a registered nurse or a licensed practical nurse. Many companies who seek applicants with an RN or LPN license may also need them to have at least one year or more nursing expertise in a medical facility.

Certification

Certification also benefits applicants for scientific analysis manager positions, and some companies need applicants to have a documentation in scientific analysis from approved organizations that offer documentation courses and examinations. The Society of Clinical Research Associates and the Association of Clinical Research Professionals are nationally recognized organizations that offer documentation programs for scientific analysis experts.

Additional Qualifications

Many companies need individuals to be proficient with Microsoft Word, Excel and Outlook. Interpersonal communication skills and encounter working in a team environment are skills needed for this job place. Strong organization and prioritization skills are also beneficial skills that companies may need applicants to possess for the scientific analysis manager place.

Supervisory Role

Many scientific analysis experts become promoted or advance to the higher level supervisory positions after gaining additional qualifications and expertise in scientific analysis. Clinical analysis planners oversee the entire process of scientific analysis investigation and tests and ensure that all medical experiments and tests are compliant with the objectives of each project. Clinical research management is a wonderful field and you can choose to make your career in this field.

Related Posts:

1)6 Ways ResearchKit Would Change Clinical Research

2)Top 10 Clinical Research Interview Questions

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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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What To Do When An Outsourced Clinical Trial face A Crisis

What To Do When An Outsourced Clinical Trial face A Crisis

Today in this blog topic we would discuss outsourcing in clinical research and how to find a solution if an outsourced clinical trial hits a roadblock.

In the 1990s and 2000s, outsourcing already revolutionized the IT industry and experts have a belief that outsourcing has the power to revolutionize scientific research in the very same way. But under present situation, outsourcing in science is very difficult. It’s hard to find providers and is hard convincing them and also difficult to evaluate them and pay them. Well other industries solved these barriers by creating a marketplace, but the question is whether same solution is applicable to scientific researchers also?

Well Science Exchange can make makes outsourcing easy and wondering how many more discoveries can be made when scientists will be able to tap into the best resources. A very exciting thought!

But the fact is that keeping clinical trials on schedule is not an easy task. Whether a sponsor face issues with timeline, quality, personal or plenty of other things with an outsourced partner, it’s critical to address the problems as soon they arise. You are right we are making mention about the barriers that can be faced in clinical outsourcing.

When a clinical study hits a roadblock, there are a few options that can be addressed. One choice is to have a 3rd party interference, evaluate the situation, and oversee the original partner until study completes. Another option is that a 3rd party rescue where the study is taken over completely.

But while you take the decision about which option you should go for that would be best for your company, consider the following:

  • How fast does the database lock need to occur? If the DB Lock date has some good time remaining, it could be best to have a 3rd party come to the rescue. But, if only a couple of weeks are left, transferring the study is probably not a good idea; this might push away the timelines out even further and increase costs. In such situation, the best solution might be to let the study be where it is, but get a 3rd party come in and take the charge.
  • Who possess the database? If your database is with the organization which initially contracted to conduct the study then moving it to another company could pose a significant challenge, as that alone needs more time and money. But if your study is being carried out by a company provides study and rescue operation, handing the task to them is often the wisest decision.

It is quite obvious that a sponsor choose a partner seeing on the monetary aspect and if the partner fails to keep the words! Over the years, two key lessons surfaced about outsourcing: (1) Need to give extra attention to the data quality produced by the partner, and (2) never accept words that appears very true and too good.

So keep the above mentioned points in mind while selecting your outsource partners, and there will be better chances of avoiding barriers in your research study.

We conclude here. Hope you liked the discussion let us know your opinion in the comment section below.

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 guide you in considering a clinical research career in this field.

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How To Get The Right Patient In Making A Decision

How To Get The Right Patient In Making A Decision

With the rise of clinical trials all over the world, there is an increased involvement of patients in medical discussions, a very welcoming policy or methodology. They have rights, not only since they are the ultimate customers but they are every essential to the entire process. Their views can help in the regulatory process, with its raising sacle of interactions like patient representatives in some of its scientific assessment of individual products.

It is a two-way path, too. For every soul concerned in healthcare sector, an informed patient can help and support make care more effective, with improved support, more developed relations with respective physicians, and wider broader understanding of the challenges of drug designing and regulation.

But this two-way path can also prove to be dangerous. Patient’s opinions and demands might not always share the logic of the process that produces their products. It is quite reasonable to seek passenger’s views on the attribute of aircraft seats, but they have quite less to contribute on airframe design or navigation. In similar ways, not every view of every patient is could be helpful in determining the most appropriate scientific, clinical or commercial approach to medicines. An wrongly informed patient can make a doctor’s life pathetic.

So how can you strike the right balance into customer links and decision-making on remedies? A European project that began at the end of October is aiming to take over this hurdle. The final outcome would be suggestions to support developing guidelines for industry and health technology assessment authorities. In simple words when and how should decision makers give an ear to the patients?

The project, sponsored by EU’s joint-venture in drug research, would mainly concentrate on three disease areas where patient and clinical trial partners have expertise: neuromuscular disorders, rheumatoid arthritis and cancer.

According to Ulrik Kihlbom, one of the Swedish academics involved in the above mentioned project, the challenge is very real and needs a thorough discussion among a wide range of partners. How could a settlement authority weigh the patient perspective against cost-effectiveness when making a repayment of money decision, he reviews? Or how does a regulatory authority weigh patient need contrary to safety matters? Patient’s views need to represent the actual opinions patients have, and be unbiased. And for the individual customer, at what point should his or her voice be listened to? When his or her first diagnosis occurred, or when was under treatment? It is recommended that the patient’s choice will definitely change during the occurrence of illness. Is it to know when your choice is such that your physician must listen to them?

At this present time in Europe, patients’ voices are being increasingly given attention on concerns as wide as access to social and health care, availability of medicines, assessment of health technology and the shaping of broad health policy, the preferable initiative is quite in time. The very question, however, is whether Europe can wait for more years for its recommendations, as “patient potential” is already coming up very strongly, whether it is “correct” or wrong.

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

With increasing Clinical research   there is an immense need to meet the current requirement of the efficient candidates, you must consider improving 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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How Clinical Research Certifications Help Pharma

How Clinical Research Certifications Help Pharma

A non-profit organization, National Board of Medical Examiners (NBME) has been around for about 100 years. Its primary mission is to assess the qualifications of healthcare professionals. Though it’s popularly associated with the U.S. Medical Licensing Exam (USMLE), NBME also has also impacted different healthcare professions, which includes medical assistants, veterinarians and physical therapists. Very recently, the group has been looking into designing an assessment that would be beneficial to clinical researchers.

The researchers conducted by NBME, has a goal to determine their main points and evaluate if there was a need for some type of standardization, especially in the area of training. They assessed there was a need for training, a method to calculate the effectiveness of it, and to lessen redundancy in training that existed.

By the conclusion of their research, NBME developed two certification programs in association with clinical research experts. One for clinical investigators and scientists, while the other is for monitors, associates, and coordinators. The mode of assessments include basic knowledge in clinical research, which includes ethics, study design, manage data and other topics professionals would need to be aware of, irrespective of their role in the clinical trial process. The two certifications vary with respect to specifics of the positions.

In order to apply for the exam and gain certification, the examinees must give their eligibility evidence, including education and experience in clinical research. The multiple answer exam takes 4 hours and 15 minutes to complete.  After the exam, examinees can review information about their performance, including areas of strength and weakness. If an organization makes the exam available to their employees, that organization can receive aggregated information on staff performance so as to identify knowledge areas in need of improvement and improve future training for researchers.

For the CROs and for sites, having this certification in place for researchers ensures staff proficiency and knowledge to current and future partners.AS mentioned, the certification is individual specific hence not portable. Once someone is certified, that certification will enable them wider opportunities. For sponsor companies, the certification ensures that their internal trials are being handled by qualified professionals.

During the start of research they found there were other programs available to clinical researchers which were webinar-based that would grant participants a certificate after completion. Their mission is to create a program that would be effective at determining a researcher’s skill set.

Though there are other clinical certifications available, like SOCRA and ACRP, and have their own certification programs, but they are quite specific to defined titles within the industry.

To conclude, Short notes NBME became aware of the requirement for certifications after the organization of physicians working in clinical trials wanted to ensure proper certification. Upon evaluating those concerns, NBME realized the need for a pathway for individuals to get into research, which involved improving those skills that they need to be successful.

Hope this certification program will delete some of those challenges and make the certification process easier for professional who want to pursue in this field.

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 guide you in considering a clinical research career in this field.

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Drug And Medical Device Clinical Trials

Drug And Medical Device Clinical Trials

To understand the similarities and appreciating the differences is essential. A well-planned and controlled clinical research can save both time and wealth. To mention, the faster and more accurately a trial is done, the faster the test article can be place in the market and begin helping the human species. In this blog topic we get together the similarities and the differences too.

Clinical trials are basic to the development of novel, investigational objects such as drugs or high-risk (and a few medium-risk) medical devices. Many products are found to be or appear safe and effective during in vitro testing or animal studies, but they can’t confer the same effect in humans. These novel products must be proven safe and effective in a clinical study in humans before use in the mass population.

Clinical trials for Drug development

Drug development is quite complex, consumes whole lot of time and resource-specific. It requires thorough attention to ensure how appropriate it is for the drug or biologic.

Clinical trials for Medical devices

For medical equipment, often there are changes in the design and use is quite common and often do not need prior approvals of regulation. In vitro and/or animal testing are often enough to assess the suitability of a design change

Differences

Drug Device
Primary Administrator Patient or Patient’s Caregiver Investigator
Principal Investigator Supervision Required? N Y
Patient Responsibility High Low
Physician Involvement Low High
Training Process Observational

Staff and patients are informed of administration process, expected side effects and adverse reactions.

In practice

Complex equipments might need extensive investigator training, including cadaver labs, animal models, or proctoring during life cases.

Cost of Product Usually given free of charge High cost with subsequent reimbursement


Similarities

Both needs adherence to the following regulations:

  • 21 CFR 11 – Electronic medical data
  • 21 CFR 50 – Human subject protection
  • 21 CFR 54 – Financial disclosure
  • 21 CFR 56 – Institutional Review Board (IRB) requirements

On the other, drug trials must abide by 21 CFR 312 (investigational new drug application) but device trials don’t need to abide. Whereas, device clinical trials must abide by 21 CFR 812 and drug trials do not.

To mention, these two regulations have a number of similarities, a few are mentioned below:

  1. The exact submission must be done to the FDA before starting an investigation
  2. Amendments are needed when changes are done
  3. Annual updates on study progress are essential
  4. Both sponsor and investigator responsibilities are well defined
  5. Investigation must be done in accordance with the investigational plan, signed agreement, regulations and conditions of approval imposed by the IRB
  6. Investigation must be properly kept a watch.
  7. IRB approval must be done prior to beginning of the investigation
  8. Labeling what is required are specified
  9. Significant information must be given to subjects
  10. Sponsors must give information to investigators

Drug and device clinical trials have several similarities and differences, but the final count is the goal and that is the same: introduce safe and effective products to the public as quickly as possible.

We conclude here. Hope you will like the compilation; it’s informative and quite simple and short. We gathered these from various web sources.

WE conclude here.

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

Clinical research jobs in Pune are getting increased and to meet the current requirement of the proficient candidates in the field of clinical trials, 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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Apple Plans Transform HealthKit From Tracker To Diagnosis Tool

Apple Plans Transform HealthKit From Tracker to Diagnosis Tool

Till date Apple’s HealthKit has mostly collected fitness data from its devices. In the future, if the company finds its way, the software will interpret that information, converting it into advice for users, doctors and others.

Many health care experts hired by Apple in recent years are designing enhanced electronic health record software that can well analyze and understand the implications of patient data.

The iPhone manufacturer is even working on new apps for the Apple Watch. It can track users’ sleep patterns. Another app focusses on fitness levels by calculating the time taken for the heart rate to fall from its peak to resting level. Apple already has an app that measures heart rate, but yet don’t interpret them.

The ultimate goal of Apple’s health care technology team is to turn HealthKit into a tool that improves diagnoses. The system could do away two problems that plague the field of clinical research and have stumped other specialist firms in the field.

Chief Executive Officer Tim Cook wants Apple to act more in improving software and services to secure new sources of economy and make customers more dependent on the company’s devices.

In early this year, Apple bought Gliimpse Inc., a startup that build software to pull electronic health records from different databases and in different formats and finally store them in one place.

He equated the product to Apple’s music business. That negan with the iPod, but as more people became habituated to storing all their music files digitally, Apple united all music lovers in a single platform on top of the device.

Apple health software might become a revenue driver, too, by keeping people intrigued to the company’s equipments. If a patient’s health records, and related suggestions, are reachable through Apple’s system, it would be difficult to trade in an iPhone for a smartphone running Google’s Android OS, and its health-tracking software Google Fit.

The second module of Apple’s Watch has a built-in GPS tracker, faster processor and is water resistant and many people can run, swim and do other exercise with the device. The upgraded Watch software, dubbed watchOS 3, puts health tracking information more prominently in the user interface, and adds a breathing during exercise app as well as tracking during swimming.

Building more sensors into the Watch serves a limited purpose. The accelerometer can generate most of the useful data needed to monitor a person’s well-being. A glucometer or blood-pressure sensor would only help a small percentage of users, the person said.

Scott Jenkins, said that Apple is working hard with many of these large institutions to produce tools that are medically significant, to take data from sensors.

Stephen Friend, a Merck & Co. veteran who founded health data non-profit Sage Bionetworks, is honored with being the brains behind ResearchKit. He joined Apple as full-time employee in June after working as a consultant for more than two years.

Yoky Matsuoka, formerly technology chief at Google’s Nest Labs unit, joined Apple’s health team last year. Nest mostly known as a hardware specialist, but Matsuoka head the development of software that interpreted and learned from data that its internet-connected thermostats collect.

Apple’s greatest obstacle for now is proving to medical professionals that data delivered from wearables through HealthKit and ResearchKit is reliable.

In the competition of many organizations CRB Tech Solutions developed a big name. Its better known in providing the best training in Clinical Research.

Clinical research jobs are increasing and to meet the increasing requirement of the peofecient professionals , 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.

Related Topics:

1) Top 10 Clinical Research Companies in Pune

2) Clinical Research Organization

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TOP 5 Clinical Research Organizations(CROs) In India

Introduction:

The clinical research industry is continuously undergoing a positive development in India. Gradually, the clinical researches are being viewed as drug discovery rather than drug development destination only. At present, many companies are looking for innovations. The famous players that are operating in the nation include MNC CROs which are dominating the country’s market . And, it is becoming important for each and every one of us to know about the popular CROs that are functioning in the nation.

This article would give an idea about some of the famous Clinical Research Organisations in the country.

The CROs that are operating in the country can be divided into two major categories:

  • Global Players with their presence in India
  • Domestic Players

Famous Global Players:

Following are a few of the famous global CROs who are having their presence in India:

Quintiles: Founded during the year 1982 when Dennis Gillings, a London based professor signed his first consulting contract. This company began its global expansion during the year 1987 and in the year 1993, the company made its entry into Asia.

Currently, this company covers the Asian continent by opening its services in around 20 cities including Bangalore, India. In our country, Quintiles has five offices in the below locations:

- Ahmedabad

-Bangalore

- Mumbai

- New Delhi

Quintiles India has the pride of holding some of the best relationships with the leading medical centers as well as with some of the experienced principal investigators.

The key services of Quintiles in India are Project Management, Clinical Trial Monitoring, Site Management, Drug Safety, Regulatory Affairs,Quality Assurance and Pharmacovigilance.

PPD: It is one among the leading clinical research organizations which was founded in the year 1985. This company has its offices in as many as 50 countries with a total number of 84 offices. In India, the company is functioning in the following three locations:

- Gurgaon

- Bangalore

- Mumbai

The clients and partners of PPD include pharma companies, medical device manufacturers, Biotech companies, academic institutions and government organizations.

And, the services that are oferred by PPD are clinical development services,laboratory services, – Consulting Services and making innovation

Paraxel: A premier provider of clinical trial services to the biopharma companies as well as the medical equipment businesses for the development of novel medical therapies across the globe for more than 30 years. Paraxel is operating in India, in the following locations:

- Delhi

-Hyderabad

- Bangalore

- Gurgaon

- Mumbai

- Chandigarh

Paraxel is offering the following services:

- Early phase services

- Phase II-III services

- Peri-approval services

- Post-approval services

- Clinical logistics services

- Consulting services

Famous Domestic Players:

Siro Clinpharm: Founded in the year 1996 by Dr. Gautam Daftary. The company started operating in Mumbai.This company also has its offices in USA and Malaysia. Various services that are being offered by this Indian CRO are:

- Clinical operations

- Clinical data management

- Medical writing

- Scientific writing

-Biostatistics as well as Statistical programming

- Clinical trial supplies

The therapeutic expertise of Siro Clinpharm includes:

- Oncology

- Cardiovascular Disease

- Central Nervous System

- Endocrinology

- Respiratory Diseases

- Infectious Diseases

GVK Bio: This is one among the Asia‘s leading discovery research and development organizations. This company has its global customer base of over 300 satisfied customers. The headquarter is located in Hyderabad. In India, the company is operating in the following locations:

- Hyderabad

- Bangalore

- Mumbai

- Gurgaon

- Ahmedabad

The services that are being offered by this CRO are:

- Discovery services

- Clinical development services

- Formulation R&D

- Manufacturing services

- Information & Analytics

- Integrated programs

Clininvent: Clinivent is the company which was established as the Contract Research Organization that is having great capabilities in the areas of clinical trial and data management. The company is located in Mumbai. The partners of this company are:

- TCG Lifesciences

- LabVantage

- Chembiotek

Various services that are being offered by this Clininvent are as follows:

- Clinical trial management

- Data management

- Pharmacovigilance

- Medical writing

- Quality assurance

- GCP training

CliniRX: CliniRX Tangent Research has been developed as an affiliate of the JK Organization which is a 125-year old entity. The JK Organization has its headquarters in India. Various services that are being offered by CliniRX are as follows:

- Site selection

- Project management

- Monitoring

- Site support

- Medical writing

- Safety surveillance

- Clinical compliance

- Biometrics

The research offices of CliniRX are located in:

- Bulgaria

- Netherlands

- United States

- Israel

In the competition of many organizations in Pune CRB Tech Solutions created a big name. Its very popular in offering the best training in Clinical Research.

Clinical research jobs demands are increasing and to meet the increasing need of excellent professionals , you should excel yourself with our clinical research institute.

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

Related Topic:

1)Clinical Research and Scandals

2)Clinical Trials : In The Clouds

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Bio-similars and the Everyday Men

Bio-similars are gaining popularity with ongoing various clinical research worldwide. What are Bio-similars ? And why the general consumers should care about them?

As explained by the FDA, a biosimilar is a biological product that is approved based on the fact that it is highly similar to an FDA-approved biological product. Biosimilars are like generics, which are drugs that are identical to a brand name drug in dosage form,strength,safety, way to administration, quality and intended use. But there is a difference between generics and biosimilars. It includes the complexity of the molecule, manufacturing and unlike generics, biosimilars are not the exact replicas of the reference drug. Hence, data required by regulatory agencies to prove similarities and obtain approval is more challenging.

Bio-similars-and-the-Everyday-Men

The pharma sector is concerned about biosimilars because, as per BioPharm International, sales of biologics have gained from $20 billion in 2000 to $159 billion in 2014. As per reports, biologics represent about 70% of the worth of the top 10 selling drugs in the world. With an approximate 19% increase in sales across the global drug market over the last 14 years there is an expectation of continuous growth, biologics and biosimilars representing billions of dollars in revenue over the coming years. Forbes reported that the sector expects 10 of the top 20 global bestselling drugs in 2016 could be biologics.

That sounds great for pharma companies, but why should the average mankind care about biosimilars? Very simple: health and money matters.

Biosimilars have the power to save the healthcare system money because they are lesser in cost than the reference drugs. Moreover, Bio-similars have the ability to become a significant economic driver for the industry; as the Frost & Sullivan analysis predicts exponential growth over the next decade.

Biosimilars may also improve the outlook for patients since they have the potential to be significantly less expensive than their biologic counterparts, thereby making them more available to the people who require them like the elderly and the not-insured or under-insured. Biologics and their biosimilar counterparts are made used to treat a broad range of diseases including dermal conditions, cancer, low WBC counts, rheumatoid arthritis, anemia and many to mention.

The ramifications for clinical trials are vast as well. Biologics, by nature of their composition are large molecules and very complex products. Additionally, they’re extremely sensitive to the locations of where and how they’re produced. Fortune compares them to snowflakes, where the molecular makeup of each biosimilar treatment will appear unique, like individual snowflakes, even though they have similar results. This is how biosimilars are different than generics. You might have two biosimilars for the same drug with the same usage, but molecularly they will look different and may act unique.

Not every clinical research unit can carry out studies with biologics since they require high safety assessment capabilities, on site physicians to assess clinical trial volunteers daily and a rigorous quality control department.

You might or might not have heard very much about biosimilars before, but you could definitely expect to hear more and more about them in the coming times. With many of the leading biologic medications dropping off the patent cliff by 2020, the world will be seeing the benefits of biosimilars sooner as per assumptions.

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