Pharmacovigilance Literature Search
Our Pharmacovigilance Specialists are experienced in performing literature searches. One of the most valuable sources to get information about medical products and devices is the already-published medical and scientific literature. It is mandatory for Marketing Authorisation Holders (MAHs), License Holders to monitor the medical and scientific literature to stay on track about the Adverse Drug Reactions (ADRs) and other important information about drugs such as misuse, off-label use, potential drug reactions, and class effects. The local literature searches are also required to review journals that are relevant to the patient. Through this research, they should find both the ICSRs and other safety-related information.
Our Services
We work with our clients to develop a search strategy and also take on sensitivity testing to ensure that the search criteria for the literature search are highly robust and appropriate.
We at Vizen run the literature search and review the results, either for specific purposes like aggregate reports, signal evaluation, or other assessment of benefit-risk or for ongoing screening of worldwide literature as a requirement of the local and regional. As you know, the EU requires at least a weekly literature screening to be performed for all products that are with or under application for Marketing Authorization.
As part of the ongoing screening, we will help you in identifying the ICSRs that are valid for the safety database entry along with identifying emerging safety signals and concerns. Outsourcing your literature research can be both cost-effective and provide you with efficient results.
We also regularly monitor and review the Eudravigilance Medical Literature Monitoring, maintained by the European Medicines Agency (EMA), for ICSRs identified in the literature if our client’s products are included in the list of active substances.
Why Vizen Life Services?
Our team of literature experts has a combined experience of two decades in global pharma. We combine our experience and expertise in delivering high-quality services to our clients. We search through multiple databases for articles that will help you in writing periodic safety reports. We are aware of and comply with all the standard pharmacovigilance guidelines and regulations. Our experts are also knowledgeable of data protection and privacy regulations to ensure that we offer our best services. One of the major challenges in pharmacovigilance literature search is the review process. You need a solid team by your side if you don’t want to miss an article for ICRs, safety signals, or an aggregate report. Our team of experienced literature reviewers will handle everything for you as we have managed the review services for some of the major pharma companies. You can count on us for providing the most efficient pharmacovigilance literature search. We use automated tracking tool to conduct literature searches which ensure fast & on time searches. The data is collected from the searches is stored for any further review. Vizen offers Journal Subscription Services, Procuring Full Texts, and Real-time translation services with ensured quality in partnership with leading translation service providers for flawless literature review.
Global Services
- Safety Database
- Adverse Events (AEs) Reporting
- Aggregate Reporting
- Pharmacovigilance Literature Search
- Pre-Preparation and Submission of Aggregate Reports
- Safety Signal Detection Services
- Risk Management Services
- Regulatory Intelligence
- Ongoing Monitoring Services
- Medical Devise Vigilance Services
- Pharmacovigilance Consultancy Services
Contacts
Visit Us
10th Floor Kapil Towers, Survey 115/1, ISB Rd, Financial District, Gachibowli, Nanakaramguda, Telangana 500032
Have Any Questions?
040-69441100
Mail Us
info@vizenlifesciences.com