Clinical Research

Clinical Trial Investigator Meetings

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Investigator meeting is an event that makes all the principal investigators and researchers to meet in person at one place to discuss and to get trained about the clinical study protocol. The sponsor hosts the investigator meeting and provides hands-on training and orientation for the investigators and study coordinators. The purpose of the investigator’s meeting […]

Clinical Research

Quality Management in Clinical Research

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Quality Management has been a part of every industry over last many decades. The concept has evolved and refined over the years and has also changed the outlook of the industry. Hence, it is no surprise to consider it of prime importance in the clinical research arena. Since this industry puts in lots of efforts […]

Clinical Research

Roles and Responsibilities of CDSCO:

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Many of us of in India, have heard about CDSCO and have got confused about its role and relation with DCGI. So what is CDSCO? CDSCO stands for Central Drugs Standard Control Organization. CDSCO is a licensing authority, a regulatory agency which approves any new chemical entity (drug) which is to be imported to India. […]

Clinical Research

Are Placebo Controlled Clinical Trials Justified / Ethical?

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A placebo controlled study is where subjects are randomly assigned to a placebo along with the intervention studied. In case there is no established/available (standard) treatment for a given condition; a placebo control is often the design of choice. However, questions are raised if a treatment is available that is more effective than the placebo. […]

Clinical Research

Regulations & Guidelines of Complementary / Alternative Medicine in South East Asia:

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The evolution of traditional medicine has taken place since thousands of years. This form of medicine has been very dominant in most of parts of South East Asia. In today’s world this form of practicing medicine is called Traditional Medicine or Complementary/Alternative medicine (TM/CAM). TM/CAM is monitored in this region under the regulations of WHO […]

Clinical Research

Advertising in Clinical Trials

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A clinical trial enrols human volunteers to determine the safety and efficacy of the new or existing drugs or medical devices in different therapeutic conditions, while the subjects well-being and rights are protected. The success of a clinical research project depends upon the subject enrolment and randomization rate. To accelerate and enhance the patient enrolment, […]

Clinical Research

Investigator Meeting (IM) in Clinical Trials

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An Investigator Meeting is usually a sponsor’s job, but a CRO may also be delegated with this task. For many from the industry, investigator meeting is much targeted and criticized for overspending. It is argued that these meetings are generally hosted to lure investigators in clinical trials but if we try to understand the need […]