pvnet.sarjen.comPharmacovigilance software & Drug Safety Database,

Pharmacovigilance software & Drug Safety Database, PvNET Menu Home Model As a Service (On-Cloud) Use the demo content and one of our predefined skinsAs a Solution (On-Premise) Ask our designer how to improve your site. It’s FREE!Validation Blogs Downloads Case Studies Ask our designer how to improve your site. It’s FREE!White Papers Use the demo content and one of our predefined skinsWebinar Videos Ask our designer how to improve your site. It’s FREE! Brochure Ask our designer how to improve your site. It’s FREE! Overview Ask our designer how to improve your site. It’s FREE!Customer Support Use the demo content and one of our predefined skinsFAQs Ask our designer how to improve your site. It’s FREE!Testimonials Ask our designer how to improve your site. It’s FREE!Contact usPharmacovigilance made easy... Adverse Event Reporting Tool - PvNET, values patient safety PvNET, Pharmacovigilance solution Values Patient Safety A Safety Database: Adverse Event Reporting Tool Power packed with rich modules Comprehensive Dashboard with multitude information Management of Safety data standards Title 21 CFR part 11 compliant ICH E2B compliant Supports Global Dictionaries, viz., WHO-DD, MedDRA Automated linking of field with reference libraries Individual Case processing for adverse events User friendly interface Management Dashboard: Alerts and workflow management Country Inbox: Auto scheduling of reports based on in-built rules Auto coding from MedDRA/WHO-DD and Auto narrative generation Global Submissions and Reports Globally compliant report formats: CIOMS, Medwatch, E2B (XML) Seamless exchange of reports with E2B partners: Regulators and Affiliated Partners Preloaded PSUR/PADER templates, FSCAs, FSNs Customized CIOMS II listings and tabulations Clinical Pharmacovigilance Drug and Device vigilance support for all phases Create project specific Investigational medicinal product (IMP) Reports as per obligations of Ethics Committee or Regulatory Authority Line Listings and Event Tabulations as per ASR requirements Product Registration (xEVMPD, EVPRM) EMA compliant Single entry, reduced errors, comprehensive coverage, with features for future reference tracking Addresses ’One to many’ product relationships Preloaded EMA controlled vocabularies and in-built validation rules Working towards ISO IDMP standards Signal Detection Proactive Signal Detection, Management and Validation In-built Data Mining Algorithms (DMAs), retrieving Drug Event Combinations (DECs) at multiple MedDRA levels Integrated Quantitative and Qualitative Signal Detection methodologies Calculation of PRRs and upper and lower bound CIs Literature Automation Automates global literature surveillance activities Seamless creation of ICSRs from literature reports Filtering of safety publications for PSUR and Signal Detection Chronologically documents activities from IRD to full text receiptPharmacovigilance Safety Suite Sarjen’s PvNET is now PvEdge PvEdge Human Triage Automation PvTrainer PrITR PvEdge VET Designed by pharmacovigilance experts Cost effective pharmacovigilance solution Compliant with E2B, US FDA 21 CFR part 11 guidelines Integrated MedDRA browser Easy XML file import and export Case validation based on in-built EMA business rules Integrated workflow stages (customizable) Auto narrative generation ensuring consistency across all cases Sarjen’s PvNET in nutshell A single platform for serious adverse event (SAE) reporting for medicinal drugs, medical devices and drug therapies. Global database which fulfills drug safety requirements of multiple regions, viz., Europe, Canada, USA, Australia, etc. Dynamic homepage helps to meet regulatory compliance and maintain work allocation across different users. Add-on functionalities for seamless ADR case processing. What’s New Veterinary Allows Initial/Follow-up Adverse event reporting of veterinary medicinal products Allows generation of all standard reports like E2B XML, FDA 1932, CVMP Integrated VeDDRA coded terminologies E2B (R3) New ICH guidelines for electronic submission of Individual Case Safety Report (ICSR) data elements and message specification Sarjen’s PvNET integrates these new E2B (R3) guidelines to generate XML’s Request for Demo Your Name: (required) Your Email: (required) Subject: (required) Contact Number: Your Message: Copyright © 2024, Sarjen Systems Pvt. Ltd. Home || Blogs | Downloads | Sitemap |...