As more and more sponsor companies from the US and EU are outsourcing clinical trials to developing countries, Bangladesh as a country has a great potential to be one of the leading clinical trial markets. Looking at the success of India, China, Thailand and other neighboring countries in this region that have been actively involved […]
James Lind Institute, Hyderabad is always looking to hire talented freelance medical writers and content developers irrespective of whether you are experienced in medical writing or just a fresher. If you have a flair and passion for writing, if you know the basics of clinical research and if tight time lines do not bother you […]
Ethics as much talked about, is arduous to understand and interpret. One always tries to interpret ethics in his or her own way. So how can we justify as to what is ethical and what not? Seems like a real googly, isn’t it? In similar sense, think about how ethics committees justify their decisions with […]
Clinical research according to ICH-GCP is defined as, “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of […]
Gone are the days when clinical research and clinical trials used to be a concept only in the western world. Clinical trials are now a global phenomenon with giant pharma and biotech companies creating a paradigm shift by outsourcing clinical trials to third world developing countries. China, India, Latin America are few top contenders but […]
Indian-GCP: Yes, you must have heard about Indian GCP multiple times, but do we really know what Indian GCP is and why it was created? Do we know the differences between ICH (International Conference on Harmonisation)-GCP & Indian GCP?, and finally the important one… DO WE REALLY NEED IT? Let us try to find answers […]
Pre-clinical drug development process is a risk based process that involves safety and efficacy evaluation of drugs in animal species that extrapolate to potential human outcome. The pre-clinical pharmacologic and toxicological drug responses with respect to dose regimen and route of administration enable to initiate and continue research in human beings. In general, pre-clinical studies […]
For some strange reason, training looks like an unattractive offering, but in reality it is essential for every Sponsor/CRO conducting a trial, to offer ample training to their clinical trial site staff where the clinical trial would be conducted. What is Study Specific Training? Study Specific Training generally refers to training which is specific to […]
NDM-1 is a gene known as “New Delhi metallo-beta-lactamase-1”, which gives certain kind of bacteria the ability to produce an enzyme called carbapenemase that renders resistance to broad range of β-lactum antibiotics. These include the antibiotics of Carbapenem family, also known as antibiotics of last resort, along with Penicillin and Cephalosporin. NDM-1 was first identified […]
We have all been talking about ethics related to patient safety, informed consent, ethics committees etc; however not much is talked about publishing of the data that comes out of every research, be it preclinical or clinical. The question is: Are research results published ethically? History tells us that when it comes to publishing of […]