Clinical Research Organization, Regulatory, Scientific Writing Services

In Brief A novel process where European Medical Agency offers a new service. The service is focused around  medical literature monitoring . This service is also a vital step to ensure that there is no duplication of negative reaction reports. This service came into effect from 1st September, 2015. Service Insights The European Medicines Agency (EMA) on 12th May, 2015 presented a politician intimation of medical literature monitoring service and also proclaimed that adverse reaction reports would be not be required to be entered within the EudraVigilance. the whole thing came into effect from 1st September, 2015 onwards. Following the announcement, the EMA has published an inventory of active substances and also provided a regard to the journals which will encompass this novel service. Initially, the service was poised to be initiated by taking around a restricted number (50 active molecules) of active substances from 1st July, 2015 and was alleged to be ...

The Role of Referencing in Scientific Writing Scientific writing  makes up an integral element within research. Of late, the pace at which findings of a research is communicated through diverse mediums such as thesis, books, conference papers and journal articles has substantially increased with widespread developments in technology and medicine. The findings from these researches are usually perceived as harbingers of development in the academic and scientific domain, driving further research or action. As is the case in any kind of academic writing, scientific writing too warrants the need for adequate references to correlate the findings with experiments conducted in the past or to indicate what researchers have said about a particular phenomenon. As a matter of fact, referencing and bibliography are vital components within a scientific paper. This article is essentially an attempt to highlight the key features, benefits and limitations of most commonly used referencing t...

Brief Different medical devices have different parameters through which it can be classified. With that reasoning, it does not make sense to subject all  medical devices  to stringent conformity assessments. Moreover, the onus of classifying a medical device is the responsibility of the medical device manufacturer. The device manufacturer has to be aware about the class under which their device will fall under, right from the time the device is in the process of development. Philosophy of Medical Device Classification In terms of practice it can’t be economically justified neither is it feasible to form all medical devices undergo every stringent assessment in terms of conformity. A system of control which is graduated should be quite enough. Under the tenets of such a system, the degree of control matches with the degree of possible risks innate within a selected device type. This warrants the necessity for a system for classifying medical devices. Th...

The Need for PMS Post Marketing Surveillance (PMS) are often defined because the process of identifying and gathering information concerning medications or medical devices after it's been approved by the concerned authorities like the Food and Drug Administration (FDA) within the US. With regards to medications, a scientific PMS process commenced way back within the early 1970s and since then, there has been a considerable increase in PMS. Drug and medical device monitoring following the method of approval has become mandatory for several reasons (FDA, 2020). Way back within the past during the 1950s and 60s, the amount of medicine within the market were very scant compared to today which made monitoring a rather easy process. within the present day, drug manufacturing has assumed magnanimous proportions and is being consumed at a really high rate. Several other factors that warrant the necessity for PMS pertains to the modifications within the approval process of the FDA....