Streams in Clinical Research

The following are the streams of clinical research.

1. Medical affairs
2. Clinical operations
3. Biostatistics and Clinical data management
4. Pharmacovigillance
5. Medical writing
6. Medical coding 

Who are the eligible for this field:

Who are having the qualifications - B.Sc., M.Sc., B.Pharm, M.Pharm, Pharm.D, MBBS, Physiotherapy, Nurse etc

All the above mentioned fields can get jobs in the streams of clinical research.

In Pharmacovigillance, B.Pharm, M.Pharm and Pharm.D having people are preferred mostly.

In medical writing doctors are preferred mostly.

Below is the image at what places the streams are working:

The actual clinical research process:

Flow and interactions of various parties involved in clinical research

Follow the numbers

Introduction to Clinical Rese...

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Clinical Research

For the people who are from science background (BSc, MSc, B.Pharm, M.Pharm, Pharm-D, Bio Tech etc), clinical research field is the best way for career.

It is the only hope to get a nice job quickly at present situation in India.

Not only in India but also worldwide clinical research has very wide scope

Clinical research

The term Clinical Research refers to the entire bibliography of a drug from its inception in the lab to its introduction to the consumer market & beyond. Not every compound that is tested in the lab is marketed. Before a drug is marketed, it has to undergo several stages of development.

Hence Clinical research may define as a “branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic procedures & treatment regimens intended for human use.”

A clinical trial targets specific health issues in human volunteers. Performing clinical trials is one of the best methods in clinical research field for finding new treatments & practices for combating illness.

Clinical trials are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the quality of life of the patient.

SCOPE

It is very clear that India has become a very preferred destination for clinical research. The industry is growing exponentially and is expected to reach Rs. 7000 Cr by 2010. Statics shows that if India's clinical trial business grows to 10% of that in US by 2015, the industry will need approximately 50,000 clinical research professionals.

Any professionals from CRO (Clinical Research Organisation), Pharmaceutical, biotech, practising doctors and fresh graduates can apply for it. Salary states is high. As arond 700 Cr. expanditure is there for single research.

Clinical Research has emerged as a popular career choice in India and abroad. Holding a strong growth potential, a clinical research profile has become a calling for many. India being a land known for Ayurveda, Unani, Siddha, and Homeopathy besides allopathy, India is growing as the preferred destination for global clinical trials.

Career in Clinical Research

Clinical Research is a systematic study to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Clinical research has become a multi-billion and multidisciplinary industry. A number of factors favor India as a clinical research hub. There are numerous government-funded medical and pharmaceutical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clinical trials.

India boasts of well-trained and qualified manpower, well versed in English. The research and the development process in India can be done at a more affordable price. More importantly, there is vast clinical material, which can be utilised, due to the prevalence of a large variety of diseases, including widespread cases of cancer and diabetes, India is viewed the world over as the ideal location for clinical research trials for the pharmaceutical industry.

Eligibility Criteria: -

Graduate / final year graduation students in Life Science, Pharmacy, Medicine, Dentistry, Paramedical Science, Allied Heath Sciences and Biotechnology. A BSc.degree is a must to enter this field. Ideally the industry is looking for science graduates from pharmacy, medicine, life science and bioscience. Within bioscience too there are various other fields such as botany, zoology, biochemistry and genetics. Anybody who fulfils these criteria can join the industry.

Job Prospects: -

The demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. According to a survey, there are 2,50,000 vacancies available worldwide 50,000 job openings in India by 2010. Highest remuneration packages owing to the shortage of skilled professionals.

Job profile: -

Clinical Research branches off into various categories at the entry level. The most common entry-level position is that of a Clinical Research Associate (CRA). The role of a CRA is varied, they are key participants in the design, implementation and monitoring of clinical trials. Bio-statistician is those who, perform statistical programming, design, and analysis for clinical trial projects.

CRM are Clinical Research Managers, they supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. There are other posts too such as Clinical Research Coordinator, Business Development Manager, Clinical Research Investigator, Clinical Data Manager etc.

Remuneration: -

There is high demand for trained professionals in this field; the pay package is impressive at the entry level. Freshers can expect a pay packet of around three lakhs or more per annum.If you have a master's degree backing your qualifications, then the amount is almost doubles. Clinical research is an industry where experience counts, thus the longer you are in this field; higher the salary you can expect. The clinical research industry worldwide is growing at unparalleled rate.

It has opened up new vistas for employment for a large number of trained professionals. The clinical trials market worldwide is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 in the UK, and they form one-third of the total research & development staff. There are more than 2,50,000 positions vacant globally and salaries vary in the region of approximately USD 40,000 per annum for a Clinical Research Coordinator.

Contract Research Organization

A Contract Research Organization, also called a Clinical Research Organization, (CRO) is a service organization that provides support and/or services for clinical trials. CROs support the pharmaceutical, biotech and medical device industries as well as foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.). There are over 1,100 CROs in the world, despite continued trends toward consolidation (many CROs are being acquired in recent times or others go out of business). It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008 and down to 55% in 2009. One estimate had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

Top CROs based on the Industry Standard Research

1. Quintiles
2. PAREXEL
3. Covance
4. Pharmaceutical Product Development (PPD)
5. ICON
6. INC Research
7. inVentiv Health (PharmaNet/i3)
8. BioReliance

The following are the streams where you can get a job at present.

 Go for it....

1. Clinical operations
2. clinical data management
3. pharmacovigillance
4. medical writing
5. medical coding 

Medical writing

Medical writing

Medical writing is the activity of producing scientific documentation by a specialized writer. The medical writer typically is not one of the scientists or doctors who performed the research.

A medical writer, working with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents comply with regulatory, journal, or other guidelines in terms of content, format and structure.

Medical writing as a function became established in the pharmaceutical world because the industry recognized it requires special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

Types of medical writing

Medical writing for the pharmaceutical industry can be classified as either regulatory medical writing or educational medical writing.

Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices andbiologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.

Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).

Regardless of the type of medical writing, companies either assign it to an in-house writer, or "outsource" it to an external medical writer or medical writing service.

Medical writing organizations

Several professional organizations represent medical writers around the world. These include:

§  American Medical Writers Association (AMWA)

§  Australasian Medical Writers Association (AMWA)

§  European Medical Writers Association (EMWA)

§  Indian Medical Writers Association (IMWA).

These organizations provide a forum where medical writers meet and share knowledge and experience. They promote professional development and standards of documentation excellence, and help writers find career opportunities. All these organizations offer fundamental medical writing training.

Finally, though not a medical writing organization, the Drug Information Association (DIA) provides many resources, including training and career opportunities (via their job board) for medical writers. Also, the University of the Sciences in Philadelphia offers a master's degree in biomedical writing.

Ø  Medical/science writing is increasingly becoming popular among PhD life scientists are having trouble finding traditional laboratory-based, research jobs. The transition from laboratory research to writing is not an onerous one; especially if you like to write.

Ø  As many of you may know, I am a freelance medical/science writer who entered the field about 10 years ago.  Because most freelancers work from home offices, the lack of communication with others can be overwhelming at times. Consequently, many of us subscribe to e-mail-based listservs which allow us to stay in touch with other writers and frreelancers. Most of these medical writing listservs are run and maintained by the American Medical Writers Association (AMWA). In order to access and participate at the listservs, you must be an AMWA member which costs $145 or more per year.

Ø  While the AMWA forums are very popular, AMWA officials assiduously monitors them and at times, restricts some of the content that can be posted. For example, members of the 'freelance business only listserv' are strictly prohibited from posting jobs or alerting others to potential freelance opportunities. AMWA officials contends that these posts are inappropriate and disruptive. However, the real reason for the prohibition may be that AWMA operates a separate, fee-based service that allows freelancers to hawk their services.  In other words, allowing  users to mention freelancing gigs or job opportunities on 'freelance business only' listserv, could potentially jeopardize an additional AMWA revenue stream.

Ø  Occasionally, freelancers like me break the rules (go figure) and mention "hot" jobs or employers who may be looking for writers. I do this because, as a freelancer, I am painfully aware that my success as a freelancer is contingent upon my ability to maintain a regular, ongoing stream of freelance gigs. Unfortunately, the AMWA officers who monitor the listservs (many of whom are not freelancers), don’t understand this. Consequently, repeat offenders-- like me--have been threatened with financial sanctions and possible expulsion from the listserv.

Producing Clear, Acceptable Clinical Study Documentation

WHY THE GROWING EMPHASIS ON MEDICAL WRITING?

With the ever-increasing demand to bring new drugs to market as quickly as possible, the process of writing easily understood clinical study documents is a growing priority for sponsor companies.

Medical writing today is much more than entering data onto a page. Cytel Clinical Research Services specializes in satisfying the growing need for regulatory-acceptable document writing that is familiar with both the emerging clinical design methods and the complexities associated with multi-national, large-scale studies.

PROPER DOCUMENTATION FOR EVEN THE MOST COMPLEX TRIALS

Cytel understands the importance of accurate medical writing as a critical component to the clinical development process. Our clinical planning expertise, meticulous attention to detail and legacy of data quality control ensure your supporting trial documentation is as accurate as it is thorough.

Also, our medical writing clients find especially valuable Cytel's ability to react quickly to urgent information requests, especially regulatory inquiries. Handling such unscheduled demands promptly and accurately is all but routine for Cytel Clinical Research experts.

Typical supporting documents include:

·         Investigator brochures

·         Protocols

·         Clinical Study Reports (CSR's)

·         Regulatory briefing documents

·         Clinical sections of Common Technical Documents (CTDs)

·         Integrated summaries

·         Abstracts for professional meetings

·         Advisory panel meetings - briefing documents, slide sets

·         Posters and presentations

·         Manuscripts


Learn more here