What is Clinical Research?

Refers to an organized research conducted on human beings to investigate the safety and efficacy of a new drug.

Is Clinical Trials same as Clinical Research?

Yes, the term clinical trials also refer to clinical research.

Who conducts Clinical Research Studies/Clinical Trials?

Clinical research studies/clinical trials are generally conducted by pharmaceutical companies, biotech companies, contract research organizations (CROs), medical device companies, cooperative groups, research and academic institutions etc.

How a Clinical Trial is conducted?

A clinical trial is conducted in a phase-wise manner. There are four phases of a clinical trial (I, II, III, and IV) each designed to address different questions. The knowledge gained from one phase is assessed before progressing to the next phase. Phase-I clinical trials are generally done to establish the initial safety of a drug usually on healthy human volunteers. Phase-II and Phase-III clinical trials are done to establish the safety and efficacy of a drug in patients with relevant indication. Phase-IV clinical trials are post marketing studies done to collect the additional safety data on a drug after its marketing authorization.

What are Good Clinical Practices (GCP) Guidelines?
These are international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve participation of human subjects.
What are the Career Options in Clinical Research field?
The entry level job positions include clinical research coordinator (CRC) position at Investigator site level and clinical trial administrator (CTA) or trainee clinical research associate (CRA) position at Sponsor/CRO level. Career growth at Sponsor/CRO level includes the positions of Senior CRA, Project Manager, Team Leader, Quality Assurance, Manager-Clinical Operations and Director/Vice President etc.
What Educational Qualification is required to enter the Clinical Research filed?
The ideal educational qualification includes graduation/post-graduation in pharmacy, medicine, dental sciences, alternate medicine and life-sciences disciplines.
Is it essential to undergo a Clinical Research Training/Clinical Trial Course to enter the field?
Recent trends in clinical research industry are suggestive of employment preference to the personnel having a basic orientation and certification of clinical research. A basic level clinical trials training not only increases the visibility of the CV but also provides the required knowledge/skills to address the specific questions during the interview.
What factors should be considered while selecting a Clinical Research Training Institute/Course?
As the entry in clinical research filed is largely dependent on the basic educational qualification of a candidate, the important factors to be considered while selecting a clinical research training institute/course include: duration of the training program (optimal duration 3-6 months); fee of the training program in terms of its worth and employability; reliability of the training program/institute in terms of years of existence, quality of training and relevant industry experience of the core faculty; and mode of the training in terms of the ease of undertaking it along with other commitments.
Where is the majority of clinical research organizations in India situated?
The majority of clinical research organizations in India are situated in Delhi, Mumbai, Bangalore, Hyderabad and Chennai. Apart from this investigator sites are present across the country.

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