Clinical Research

India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth 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.

Clinical research is all set to become the next big thing in India. A large population with a substantial workforce and cost benefits influence multinationals to set up research facilities here. Besides 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.

What is Clinical Research?.
A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product. These are carried out prior to the release of the medicine in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or contract research organisations (CRO’s) on their behalf. It is this sector that is driving the growth in clinical research in India.

So, what does one need to become a part of this rapidly growing industry?

Eligibility.
B. Sc. 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.

Individuals with prior work experience of 2-3 years are preferred, but like the BPO industry, there is a dearth of trained professionals here too. Thus, with the right qualifications finding a job in clinical research should not be a problem.

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

They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.

They assist in preparation of presentations and manuscripts of scientific meetings and technical journals and attend scientific/professional meetings and training courses as appropriate.

BIOSTATISTICIAN are those who,

Perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile. In addition they are responsible for New Drug Applications and Biological License Applications submissions.

CRM are Clinical Research Managers,
They supervise design and writing of protocols, case report forms and informed consent forms for clinical trials. They ensure that Case Report Forms are reviewed in a timely fashion and submitted to the data management group. There are other posts too such as Clinical Research Coordinator, Business Development Manager, Clinical Research Investigator, Clinical Data Manager etc.

Where to Study?.

Academy for Clinical Excellence (ACE) Website: www.aceindia.org It offers courses like Clinical Research; From Theory to Practice, clinical Research and GCP for investigators, Quality assurance in clinical research etc.

Institute of Clinical Research (ICRI) Website: www.icriindia.com It offers the following courses:

Two year full time – Masters in Clinical research + MBA

Two year full time – MSC in Clinical Research

Part-time post graduate diploma in Clinical Research (1 year)

PhD in Clinical Research.

Bombay College of Pharmacy: Website: www.bcpindia.org Offers Bachelors, Masters, and Doctoral programme of study in Pharmaceutical Sciences.

Cliniminds – Academy for Clinical Research Training & Management – Website: http://www.cliniminds.com – institute offers wide range of clincial research courses; diploma programs in Pharmacovigilance; Quality Assurance in Clinical Research; Biostatistics; Investigators; GCP Training; Monitoring and several other programs.

 

Incoming search terms:

 A new study from scientists in a department of physics shows just how physics and biomedical research can overlap for breakthrough results.

A study that has been accepted for publication (actually publishing electronically at the end of January 2010, and will be available for journals after that), from the University of Bath in the United Kingdom, reveals a new method for individual molecule mapping of proteins in biological cells – discovered by physicists.

The study, titled , discusses how understanding the structural organization and distribution of proteins in biological cells is of fundamental importance in biomedical research.

Traditional use of conventional fluorescent microscopy for this purpose is limited due to its relatively low spatial resolution compared to the size of a single protein molecule.

New atomic force microscopy (AFM) allows achievement of single-protein resolution by scanning the cell surface using a specialized ligand-coated AFM tip.

However, because this method relies on short-range interactions, it is limited to the detection of binding sites that are directly accessible to the AFM tip.

The research scientists have developed a method based on magnetic (long-range) interactions and applied it to investigate the structural organization and distribution of endothelin receptors on the surface of smooth muscle cells.

The endothelin receptors were labeled with 50-nanometer superparamagnetic microbeads and then imaged with magnetic AFM.

The scientists conclude that considering its high spatial resolution and ability to “see” magnetically labeled proteins at a distance of up to 150 nanometers, this approach may become an important tool for investigating the dynamics of individual proteins both on the cell membrane and in the submembrane space.

This is exactly the type of scientific research breakthrough that will lead to new and better medical treatments in the future.

Remember – besides new technology there is always new information available about vitamins and herbal remedies, and even exercise machines and diet fads. Please consult your personal physician before making any changes to your diet, exercise or supplement routine.

The study abstract is currently available online at ScienceDirect with the full text available January 30,2010.

Sources:

Single Protein Molecule Mapping with Magnetic Atomic Force Microscopy, Andriy V. Moskalenko†, Polina L. Yarova‡, Sergey N. Gordeev† and Sergey V. Smirnov‡
† Department of Physics, University of Bath, Bath, United Kingdom
‡ Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom
Received 6 July 2009; accepted 15 October 2009.
Editor: Levi A. Gheber.
Available online 30 January 2010

Incoming search terms:

A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product (drug), biologics or device. Clinical trials are carried out prior to the release in the market. These trials are undertaken at various stages and studies are conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or Contract Research Organizations (CRO’s) / Site Management Organization (SMO’s) on their behalf.

Worldwide clinical research market is worth over 23,920 crore ( billion) 70 percent of the business is generated within the US.
In Asia, the major destinations for clinical research are Singapore and India – estimated to be worth 11,500 crore (.5 billion) by 2010.
Currently 2, 50,000 positions in clinical research are said to be available worldwide; with 50,000 job openings in India, with this year.

Africa                        :  1993

Central America        :  1370

East Asia                   :  6180

Japan                        :  1508

Europe                      :  22561

Middle East                :  3373

North America           :  52167

Canada                     :  7215

Mexico                       :  1187

United States             :  48027

North Asia                  :  1591

Pacifica                      :  2780

South America           :  2806

South Asia                 :  1525

Southeast Asia           :  1628

Who can make the career in Clinical Research:

Student with the following qualification have done the courses in clinical research can enter into the clinical research field.

A graduate or postgraduate in Bioscience/Life Sciences (with any of the following subjects: Biotech, Botany, Zoology, Chemistry, Nursing, Biochemistry, Microbiology, Genetics, Home Science).
BE or Btech Biotech
A graduate or postgraduate in Pharmacy or Pharmaceutical Sciences
Graduate  or postgraduate in Health Sciences (MBBS / BDS / BAMS / BHMS / BUMS / BVSc / BSSM)
Graduate from a recognised university in Allied Health Sciences (BMLT / BScMLT / BPT / BMIT / BScMIT / BHIA / BScHIA / BOT / BSc (Sp & Hg) / BASLP / BSc Opt.

Site Coordinator, Clinical Research Associate, Medical writers, , Clinical Research Manager and Drug Development Associate, Biostatistician, Quality assurance
Principal Investigator, Co-Investigator, Medical Advisor, Drug -Developers, Regulatory Affairs Manager, Clinical Research Physician.
Business Development, Clinical Project Management, Clinical Research Management, Regulatory Affair Management.
Clinical Data Manager, Drug Development Associate.

There is high demand for trained professionals in this field; the pay package is impressive at the entry level.

Fresher can expect a pay packet of around three lakhs or more per annum.
If students  have a master’s degree backing their qualifications, then the amount is   almost doubles.

Incoming search terms:

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