Pharmacovigilance is Booming with its market size expected to expand at a CAGR of 14.2% through 2020. In 2014 the market was at 2,75 Mn $ which is now expected to reach 6,10 Mn $ by 2020. It is believed that the growth is attributed to CAGR of 15.5% in Phase III clinical trials, further needless to say that 57% of global pharmaceutical companies outsource their projects to contract research organization.                Outsourcing trend of pharmaceutical companies has projected increase the market size of Pharmacovigilance , which in turn benefits the not only the vendor (by creating more job opportunities) , it also benefits the Pharmaceutical giants by increasing their capitalization by working on shorter turn-around time and also avoiding operational cost in Talent acquisition and Infrastructure for carrying drug safety operations. Reference:  https://goo.gl/h3vc8i

We have quite often heard about the contingency plan for an Audit, especially when it is a regulatory inspection, like by the US FDA (United States Food and Drug Administration) or MHRA (Medicines and healthcare product regulatory agency).  Claris recently underwent a regulatory inspection by the US FDA and was given the green flag with no observations reported. With compliance being the utmost priority for every inspection, it has become essential for every Marketing Authorization Holder (MAH) to have an audit response team, which would capable and qualified to understand all the norms and requisites for a regulatory visit. Over the past several years it has been observed that FDA has been proactive in constantly monitoring ADR and compliance which has led it’s issuing of ‘Form 483 warning letters and citations’ to many companies.  Form 483 refers to the 21 United States Code (USC) part 374 which authorizes US FDA to conduct ‘Inspectional obs...

European Medical Agency would be releasing a new version of EudraVigilance system, which is expected to go live in November 2017, EMA in their report mentioned that they would be publishing a checklist of readiness for all the stakeholders to prepare them for the changes which will come along with the launch of the revised version of EudraVigilance, for which EMA also intends to provide eLearning modules, support webinars and face to face training. The prototype of EudraVigilance test environment or XCOMP is already scheduled to be released June 2017 which will let all the National competent authorities to test Individual case safety reports in E2B R3 versions. We at Think I are also driven to produce Pharmacovigilance safety  database solutions using cloud based technology which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event.  For more details, contact us at +91 ...