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 […]
Stem cells are unspecialized cells that have ability to self-regenerate and ability to differentiate into other cells. Stem cell technology is being used in treating many diseases those formerly have no treatment, but most of them are in elementary stage. In recent years, clinical trials with stem cells have taken the emerging field in many […]
We are quite known to the term ICH-GCP and most of us have an understanding that GCP (Good Clinical Practice) are guidelines that have been proposed by ICH for the Clinical Research arena. Let us now focus on the organisation of ICH, which very few of us have tried to explore. As we all know […]
Pharmacoepidemiology is a sub-discipline of epidemiology which is concerned with evaluating the efficacy, effectiveness and safety of pharmaceutical products while Pharmacoeconomics is branch of health economics which highlight the evaluation of pharmaceutical products in terms of their value for money. When we observe largely, it seems that the goals of pharmacoepidemiology and pharmacoeconomics are similar […]
World Health Organization defines Quality Of Life as ‘individuals’ perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, standards, expectations and concerns”. Quality Of Life depicts the difference i.e. the gap between the hopes and expectations of a person […]
In clinical trials, if we analyze, it is the randomization that yields accurate scientific evidence. In other words it means that causal relation between intervention and outcome is result of randomization. Randomization is a method of allocation of treatment in patients in a study at random. What this results in is that every patient/subject gets […]
In any clinical trial, the data generated is the most important thing. In multi centre clinical trials, the data shall be generated in much geography making it challenging to handle the data. Collecting the data from all the sites is a prolonged process in case of clinical trials using paper based CRFs. With the arrival […]
World Health Organization defines a Medical Device as, “any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: Diagnosis, prevention, monitoring, treatment or […]
A CTMS is a customizable software system to manage the clinical trial data generated by pharmaceutical and biotechnological companies. Starting from planning of the research proposal to the preparation, conduct, and report generation, a CTMS maintains and manages the up to date clinical trial data. The early phase clinical trial data is managed and maintained […]
In the research arena, publication of trials or studies conducted is intended towards society for better understanding of the innovative ideas and concepts. But this it is not the sole motive. Other motives are to implement the conclusion in prescribing habits, healthcare resource utilization, make changes in public health policy or regulatory practices. There are […]