Every professional in Clinical Trials will agree to the fact that clinical trials are an expensive, long and very complex activity. Sometimes it takes 10 to 15 years and billions of dollars for pharmaceutical companies to get their product marketed. Statistics have confirmed reports that the number of molecules which enter the market to become […]
Antibiotic resistance is defined as the infection which does not respond to a particular drug as a result of bacteria changes that make the infection immune to the drug. The drug resistance phenomenon is a huge source of concern with the doctors, physicians and scientists all over the world. If this continues, and if sources […]
Narrative writing is an important part of Pharmacovigilance and in patient safety as well. Usually patient narratives are written in case of Adverse Events and Serious Adverse Events including deaths. Patient narratives form a very important part of clinical study reports and all other post marketing activities. In case of a Serious Adverse Event it […]
The Supreme Court of India has acted upon the DCGI and has made it mandatory for all Multi National Companies and whoever wishes to conduct clinical trials in India to compulsorily video record the informed consent procedure in clinical trials.
The process of vaccine development lasts for a minimum of 10- 15 years and needless to say, it is a very complex process. Of all the candidates selected for development, only a tiny percentage makes it to the final licensing state, which makes the process of vaccine development extremely expensive. Vaccine development involves a combination […]
The history of drug discovery makes an interesting read. Many of the drugs which are used today were discovered accidentally or by chance
Chemotherapy induced alopecia also known as the (CIA) is a distressing side effect of the treatment which induces hair loss in patients. For many patients, it is an emotionally stressful time as their hair is a part of their image and the way other people look at them when they step outside
Outsourcing in Clinical Trials is very rampant these days, the initial days of outsourcing started in the 1990s. What exactly does this term “outsourcing” denotes in Clinical Trials? In business terms, outsourcing refers to contracting the business to a third party.
A clinical trial protocol is a legal document which outlines the study plan of the clinical trial in a detailed, yet comprehensive and concise manner. The protocol must provide a valid scientific rationale for the conduct of the clinical trial as well as make sure that the rights of the patient is safeguarded, maintaining the […]
A patient support group is constituted as a common forum or locus where patients with common diseases or interests can obtain information about their condition, share feelings and experiences and attain a sense of belonging and acceptance. Even though not being fully representative of the disease population, the pharmaceutical industry has long recognised the marketing […]