Q1: What is Clinical Research?

Clinical research is research conducted with human subjects, or material of human origin, in which the researcher directly interacts with human subjects. Clinical research helps doctors and researchers to find new and better ways to understand, detect, control, and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions. For example, the study might explore the best ways to treat people with colon cancer. By studying cancer cells from patients, researchers may be able to determine the specific genetic mutations (changes in gene sequence) that caused the normal, healthy cells to become cancerous, and may help doctors decide on the best drugs to prescribe or surgeries to perform. Clinical research today may help other doctors in the future screen their healthy patients before they ever develop cancer.

Q2: Why is Clinical Research Industry a great field to work?

In the next few years, many key patents will expire and major pharmaceutical companies (i.e. Pfizer, Eli Lilly, Merck, Apotex, GSK etc) will be looking new pharmaceutical products off the laboratory counter and on to the pharmacy shelves. Lot of jobs / opportunities for various professional will be created. This major boom in new pharmaceutical products will occur within the next few years. In order to accommodate this, the pharmaceutical industry is going to switch from pre-clinical research and development to large- Scale Clinical trial work. As such, the industry will observe a atmosphere rocketing demands for research professionals. In depth industry analysis shows that unless serious measures are taken the clinical Trial Sector will face major lack of professionals in the next several years.
Clinical research founds base in a variety of new upcoming fields Nanotechnology, Stem Cell therapies, Biometrics, Booming industry of Devices, Diagnostics & Artificial Organs.

Fields like biotech which is highly hopeful in India & Globally is set to bring market biopharmaceuticals for which there is an expanding base of demand.

Q3: Careers prospects in Clinical Research?

If you have the right educational & training background to enter this industry. List of Sample Positions for Trained & Qualified Professionals within the Biopharmaceutical Industry:

Clinical Research Investigator
Clinical Research Coordinator
Clinical Research Auditor
Clinical Research Associate
Quality control Manager
Business Development Manager
Project Manager
Medical Affairs Manager
Content Development Manager
Medical Writer
Data Manager
Regulatory Affairs Manager
GCP Trainer
Site Development Manager
Good number of freelance working options
Self Employment Options available.

Q4: What is a clinical trial?

If a clinical research study involves testing or studying a drug or medical device to see if it is a safe and effective treatment for people, it is called a “trial.” For example, a clinical trial may test the effectiveness of a new drug for treating Parkinson’s disease.
Many new medicines and drugs are found to work in the researcher’s lab, and to be safe and effective in animal tests. But drugs and devices must be proven to be safe and effective for people before the Food and Drug Administration (FDA) can approve them and doctors can prescribe them. The FDA has strict rules that govern how clinical trials are conducted. These rules are designed to ensure the safety of those who participate.

Q5:What are clinical trial “phases?”

Clinical trials of experimental drugs proceed through four phases:

In Phase I clinical trials, researchers test a new drug or treatment for the first time in a small group of normal, healthy volunteers (about 20 to 80) to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II clinical trials, the study drug or treatment is given to a larger group of people (about 100 to 300), including patients with the particular disease, to see if the drug or treatment is effective, and to further evaluate its safety.

In Phase III clinical trials, the study drug or treatment is given to large groups of people (from 1,000 to 3,000), including patients, to confirm its effectiveness, monitor side effects, compare it to other commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV clinical trials are done after the drug or treatment has been approved by the FDA and marketed for public use. These studies continue testing the drug or treatment to collect information about its effect in various populations and gather data on any side effects associated with long-term use.

Q6: Scope of Clinical Research in India?

1. A large hub of medical professionals & low cost medical facilities: – India has a talented pool of Clinical Research Professionals, Physicians and Investigator sites eager to take part in GCP trials.

2. Wide spectrum of diseases & large patient pool:- India has wide spectrum of diseases (urban lifestyle and tropical) due to its varied environment& a large pool of patients.

3. Biodiversity of population / Gene pool advantage: – The country has a heterogeneous mix of people several gene types such as Caucasians,Mongoloid and Australoids can be found in India.

4. Potential Market: – For global Pharma majors, this represents a potential market for clinical trials of a wide range of untested drugs.

5. India has well-defined guidelines: – India has well-defined guidelines for carrying out various phases of clinical trials.
6. Indian Economic Environment:- At present, the global off-shoring potential in life sciences and healthcare is about $220 billion, with an annual growth rate of 8-10 per cent.
8. Government of India’s Initiatives: – India became a member of WTO in 1995 and agreed to adhere to the product patent regime by 2005. This has led to a significant growth in pharmaceutical industry (>15%) and increased stakes of MNCs in Indian operations.

As part of TRIPS (Trade Related Intellectual Property Rights) the Pharmaceutical Industry will have the right to patent products as well as processes throughout the world including India.

Being a member of GATT / Trips, India will also have a process and product patents that will be consistent with the patent laws prevailing in the most developed countries.
9. Data Quality & Global Acceptance:- India′s credibility has been proved with acceptance of data generated from India, at all International conferences and journals. India has been a part of the many FDA & EMEA registration studies.
10. English & IT Literate population:- The country is renowned for it′s prowess in Information Technology. English is a primary language of education and communication among Indians.

Highly paying career, with good starting average salaries and an extra ordinary growth with experience. This is the right time to join as there is scarcity of trained medical/ scientific professionals in the present scenario.
One of the most booming industries in India.

Q7: Are Clinical Research Professionals in DEMAND?

Yes, Clinical Research Professionals are very much in demand. Global consultancy Mc Kinsey & co. estimates that by 2010, global majors would spend multibillion $, just for Clinical research in India. And there will be requirement of around more than 50,000 trained professionals by 2012.

Q8: Eligiblity to be Clinical Research Professional?

Eligibility: Graduate or Post Graduate in Life Sciences, Microbiology, Biotechnology, Pharmacy, Medicine, Nursing, Physiotherapy, Dentistry and Veterinary Science.
To be Clinical Research professional, you do not require any special qualifications but you definitely need special education from professional institute namely Pinnacle.

Q9: What is the typical background of the students that enroll in the I.I.C.R?

Graduate of Biotechnology, Biochemistry, Microbiology, MBBS, MD, Pharmacy, Pharmacology, and other Science graduates and post graduates. Personnel currently working with CROs and Lifesciences companies opts for these programs

Q10: Are the programs AICTE/ UGC approved?
Industry today looks for the knowledge and not the accreditations. After all it will be your Knowledge and Skills which matters in business world and that’s what Industry looks while interviewing the candidate.

Q11: Is it better to join Clinical Research immediately after graduation?

Yes, of course, earlier you join the industry, earlier you get trained and experience and obviously earlier you achieve seniority and an excellent growth in your career.

Q12: When can I join to the course?

For more information contact our Cmapus and meet our Academic counselor.

Q13: What are the type of training that you offer?

We offer classroom programs, Distance learning programs, Professional Training as well as on-job training programs.

Q14: Need for Training Programs?

1. Presently the demand for trained manpower in the field of Clinical Research is over 10,000 trained personnel per annum.
2. The currently trained manpower coming per year – 1,000 to 1,200 only.
3. The expected trained manpower requirement in the next 5 years is going to be over 50,000 persons.
4. More and more international CRO′s are starting operations in India.
5. Huge gap in Demand & Supply of trained manpower — A huge gap.
6. Most staff is provided on the job training, which wastes critical employer resources and time.
7. Excellent Career Growth.
8. High Annual Salary Growth — 30 to 35% per annum, in comparison to average 15% growth in salaries.

Q15: Earnings/ Remunerations, type of jobs?

-Salaries differ quite widely and depends largly on companies protocol. But earning is definitely better than conventional career.

-9 to 5 Office Working Hours with a good quality & family life.

-The work requires a fairly smart dress code.

-Self-employment or own Freelance work & excellent career advancements are possible.

-High Annual Salary Growth — 30 to 35% per annum, in comparison to average 15% growth in salaries in other industries

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