pharmacovigilance Literature review search services
Pepgra offers
pharmacovigilance Literature review search services as a part of the drug safety and efficacy services. Our medical
regulatory staff have extensive experience in checking out articles from multiple databases published and may comprehensively manage
your literature screening requirement during a cost-effective manner in conjunction with writing
periodic safety reports.
Our
literature specialist team of Pepgra has
15+ years of experience in global pharma, with attention on literature. We work closely with customers on
one-on-engagement model and develop the search strategy methodology to make sure that criteria are
robust and an unbiased approach. We perform the literature search be for
aggregate reports, or benefit-risk analyses or for signal evaluation or ongoing
screening as needed by
local and regional requirement.
Our weekly
search isn't only
limited to the identification of individual case safety reports but also
detection of questions of
safety . we will conduct
literature screening as per your requirement in local territories.
Our pharmacovigilance
researchers are conscious of the quality pharmacovigilance guidelines and
regulations, including 21 CFR part 314.80 and 600.80 and basics of clinical
development of a drug. additionally , our reports are going to be prepared
supported ICH E2C (R2) PBRER and other reports (PFSB/SD 0917/2; PFSB/SD 0216/2;
PFSB/SD 033 /9).
Our writers
also conscious of data protection /privacy regulations, and work under
stringent timelines in tandem with multiple stakeholders who may need different
opinions, to reach an appropriate consensus during a timely manner.
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