The Rapid Growth of CR Industry Analysis and Forecast

Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry.

What is clinical research?

Clinical means: ‘Treatment of patients’ RESEARCH’ means: ‘Systematic investigation & study in order to establish facts & reach new conclusions’ clinical trial (also clinical research) is a research study in human volunteers to newer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and ways to improve health. Clinical trials are the final step in a long research process that includes preliminary laboratory research and experiment. Types of clinical trial Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings. Phases of drug development Identification of new molecule screening is a biological activity/experiment design Reformulation Formulation Stability testing.

Phases of Drug Development are Steps prior to human trials Preclinical (nonclinical) Animal and in vitro studies. A study to test a drug procedure or other medical Treatment in animals. Preclinical studies are required before clinical trials. Investigational new drug application (IND) or Investigational device exemption (IDE) for the FDA Basis for phased drug development Safety Pharmacology Efficacy Phases of Drug Development Phase

Scope of Clinical Research (CR)

Clinical research is a side-stream of healthcare sciences. It determines the safety and effectiveness of medicines, equipment, and diagnostic products etc prior to release in the market. Sometimes, people get confused between CR and clinical practice. The difference, one is to collect evidence to establish a treatment, while lateral is used to embellish treatments itself. Clinical research is referred to the complete bibliography of a drug, device or a biological test. There is a huge requirement in Clinical Research in India which can be discussed as follows.

Career in Clinical Research

Clinical research is the way of advancing knowledge about health, illness and healthcare. There are various types of contemporary career options which you will get in this field. The medical industry is growing exponentially in India and the growth will be increase ever after. Some jobs in clinical research are listed out below

• Clinical research associate

• Clinical research Investigator

• Data manager

• Clinical trial auditor

• Project manager

• Business development Manager

• Clinical research manager

• Clinical Trials writer

Types of Jobs

There are many areas in clinical research industry demanding skilled and qualified professionals

•Clinical Monitors / CRAs

•Clinical Research Coordinators / Site Coordinators

•Drug Safety Personnel

•Project Personnel

•Medical Monitors

•Regulatory Affairs Monitors

•Medical Writers

•Quality Control / Assurance Personnel

•Data Management Personnel

•Statisticians

•Scientists

•Lab Personnel

•Management & Support Personnel

Types of Employers

•Pharmaceutical Companies

•Contract Research Organization

•Hospitals

•Non Government Organization

•WHO

Key Cities in India for Clinical Research

Following cities in India are having clinical research companies as well as opportunities

• Delhi &NCR Region

• Mumbai

• Pune

• Ahmadabad

• Hyderabad

• Bangalore

• Chennai

• Goa

Challenges of current CR Industry

Major gap in Demand & Supply of trained manpower �" An unmet need By 2012 Indian market would be over US$2 billion, and would continue to grow at rapid pace. Over 75 CROs & 60 In-house Pharmaceutical Clinical Research & R&D Facilities in India and increasing Current trained manpower demand the field of Clinical Research is over 10,000 trained personnel per annum. By 2012 over 50,000 certified/trained professionals will be required. The current facilities are able to train only 1,500 professionals. Employers required well trained professionals. Very rapid growth in number and size of Company lack of specialization Spectrum of skills required is in scarcity Limited pool of pranced people employee retention continuous training