Global and Local Literature Search Services with Scientific Translations
Literature Review in Pharmacovigilance
Global and Local Literature Screening of regional and worldwide medical and scientific literature forms an integral part of the ongoing safety surveillance of products.
Worldwide Literature surveillance is done on daily/weekly basis for identifying significant safety information related to safety signals, risks and ADRs. Based on the relevant safety information, benefit risk analysis of the product is evaluated in periodic safety, risk assessment and signal detection reports.
Medical and scientific literature search is done in an electronic database (PubMed, EMBASE, Medline, etc) by implementing a strategic search with relevant key word.
MLM (Medical Literature Monitoring) EudraVigilance case download from EVWeb and review done on daily basis for products marketed and authorized in EU.
After conducting literature search, all the retrieved scientific literature data is compiled in a preapproved template which would be reviewed by highly trained scientific experts and medical professionals.
Following literature review, all articles with relevant safety information is identified and expert comment/analysis is provided which is used in periodic safety reports for regulatory submission.
iSafety has extensive pharmacovigilance experience in handling all kinds of medical and scientific literature for various MAHs globally.
Our resources are all health care professionals with more than 15 years of global pharmacovigilance experience and expertise and are well versed with multiple local regulatory guidelines.
We are pioneers in establishing a signature literature search template with color coding as per safety significance (Risk/Signal/ADR) and relevance, this makes is easy for MAH to identify relevant safety articles from multiple articles.
Search strategy used is with conjunction with regional/global and regulatory standards post approval from the sponsor/MAH.
We support scientific translations of literature articles obtained in foreign language.
Being regulatory and audit complaint, we deliver reviewed articles with significant safety information related to safety risks, potential signal or ADRs well within stipulated timelines.
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