Clinical Research Organization, Regulatory, Scientific Writing Services

Pharmacovigilance   also Known as Drug Safety, is that the  Pharmacovigilance services   concerning the gathering , detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.   As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. The condition, that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the foremost recent amendment of the applicable legislation Medication errors like overdose, and misuse and abuse of a drug also as drug exposure during pregnancy and breastfeeding, also are of interest (even without adverse event itself), because they'll end in an ADR.   Information received from patients and healthcare providers via phar...

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 o...

1. PubMed PubMed is probably the primary web-based free program which will strike within the minds of the medical authors. it's a free online collection of medical journal papers collected by the National Library of Medicine(NLM) of the us National Institutes of Health. This includes quite 25 million documents and scans an outsized number of databases including the so called MEDLINE and other NLM journals like MedlinePlus. You can filter your search with ease for every and each topic in PubMed by typing search terms to the MeSH (Medical subject text heading).This is a filtering mechanism for locating specific journal papers. It also provides PMC citation and NCBI Bookshelf. 2. Ovid There are other search engines that hunt down MEDLINE like Ovid, ProQuest ,and Ebscohost. except for this, you've got to manage the login access from your university. Ovid may be a program that's analogous to PubMed. But it's a transparent edge over PubM...

During recent times, regulations related to pharmacovigilance services   have concentrated largely on medical literature monitoring (MLM), which is a complex procedure, the scope of which continues to deepen and widen.  Background Adverse drug reactions assume much significance in terms of risk associated with safety of patients and will make a serious impact on costs related to health systems. due to its significant implications for public health and safety of patients, regulatory authorities round the world have enforced and put into practice novel legislation s associated with pharmacovigilance in recent times. From a historical standpoint, activities associated with pharmacovigilance largely hinges on undertakings for detection , which is executed on data assimilated from impulsive reporting systems. But since health professionals tend to under-report any adverse drug reactions, the main target of latest legislations are largely on pertinenc...

Periodic Safety Update Reports (PSURs) are nothing but  pharmacovigilance Service s  documents that are intended to offer an assessment with regards to the risk-benefit balance of a specific medicinal product at time points that are predetermined, following its authorization. Periodic SafetyUpdate Reports (PSURs)  PSUR; What is it? Periodic Safety Update Reports (PSURs) are nothing but Pharmacovigilance Services   documents that are intended  to supply  an assessment with regards to the risk-benefit balance of  a selected  medicinal product at time points that are predetermined, following its authorization. The key idea of the PSUR is  to supply  an in depth  and vital evaluation of the risk-benefit balance of  the merchandise  , while taking into consideration novel or emerging information  associated with  safety  within the  context  of accelerating  information  conce...