PG Diploma in Clinical Data Management – An Introduction


Clinical research is an important branch of healthcare science which includes a study about various medicines, their effectiveness, safety and other details and make sure that they are safe for use. A team of experienced professional is involved in carrying the research. Clinical data management has an important role in clinical research.

It involves the collection of data from clinical researches. The data collected should be reliable and sound, and of high quality. Data management greatly reduces the time from the development of a drug to its marketing. There are various institutes that offer PG Diploma in clinical data management. It provides distance as well as classroom training for the professionals.

PG diploma in clinical data management involves a detailed study of drugs, biological and device development and about the rules and regulations that that control clinical research. The clinical data manager should have a thorough knowledge in clinical trial development and management.

The eligibility for this course is BAMS, MBBS, BHMS, BDS, BPharm/MPharm and graduates or post graduates in any stream of Science. The duration of the course is 10 months and it includes classroom teaching, assignments, exercises and workshops.

Other than clinical data management you are also taught an introduction to clinical research, new drug development, ethics in clinical research, guidelines and regulations in clinical research, clinical trial management, drug safety and Pharmacovigilance and so on. The clinical data manager has to supervise the entire clinical trial. The data from the trials is collected by him and he makes the further decisions. So, he needs to be an expert in this field and know everything about data management.

The Pharmacovigilance training course involves identification of therapeutic drugs, devices or biological, evaluating their quality and minimizing their harmful effects so that they are safe for use. Because of many adverse effects of drugs, the safety rules for the drugs have been strengthened recently, which lead to an increase in the demand for pharmacovigilance services. So, availing this course provides you a lot of job opportunities.

Post graduation in a Pharmacovigilance course consists of a duration of 6 months and the eligibility is:

• MBBS, BDS, Veterinary science or Nursing.

• Graduates or post graduates in pharmaceutical science

• Bachelors degree or post graduation in life science

• Final year students who are studying for the above mentioned courses may also apply

The course module for a Pharmacovigilance training course includes:

• Pharmacovigilance and pharmacoepidemiology

• Research Design and Methodology

• Statistical analysis and interpretation

• Pharmacovigilance practice

• Business Principles

• Information warehousing

• Regulatory affairs

Once you complete the course you will get a job immediately in any of the top companies in India and abroad with attractive packages.


Source by James Hana

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