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Pharmacovigilance services brochure - Provenance research

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  1. 1. VIGILANCE Pharmacovigilance Services PROVENANCE PHARMACOVIGILANCE SERVICES ADVERSE EVENTS PROCESSING Provenance Research offers comprehensive Our Pharmacovigilance experts specialize in the pharmacovigilance services to pharmaceutical, management of both clinical trial and post-marketing biotechnology and medical device companies across AE’s and offer complete support from case creation their product’s lifecycle. Our pharmacovigilance to submission. We process cases in either the client’s team consists of healthcare professionals with database or our database. wide clinical, as well as drug safety experience DILIGENCE spanning multiple therapeutic areas. The dedicated CASE CREATION AND TRIAGE team of pharmacovigilance associates, scientists, and physicians are experts in recognizing, • 24/7 call centre support for collecting adverse processing, analyzing and reporting adverse events. event reports from clinical trials and post- marketing sources • Triage of cases based on seriousness and PROVENANCE ADVANTAGE expectedness • Expertise that covers both pre and post marketing pharmacovigilance. CASE PROCESSING • Comprehensive SOPs, Quality Management • Entry of adverse event data Systems, and Compliance measures maintain • Active query and follow-up of cases the pharmacovigilance system audit and • MedDRA coding COMPLIANCE inspection ready. • Safety narrative writing and quality check of case reports for data completeness • Significant reduction of costs for the client that can be allocated to their R&D. MEDICAL REVIEW • Electronic adverse event reporting capabilities. • Qualified physician review of the cases for completeness, accurateness, and capture of all • Application of good pharmacovigilance medical concepts practices and integration of new regulatory • Medical assessment/Causality assessment and technical developments to the system. • Signal detection and Benefit-Risk analysis SUBMISSIONS PERFORMANCE • Adverse events tracking and routing • Expedited reports submission to regulatory authorities • Regulatory reporting to authorities, investigators, and ethics committees
  2. 2. Engagement model Location DILIGENCE CORPORATE OFFICE Provenance Research India Private Ltd. “JP & Devi Jambukeshwar Arcade, Provenance provides customized and cost-effective Ground Floor, No 69, Millers Road, pharmacovigilance solutions based on the requirement Bangalore-560052 of the clients. We adapt our processes to match the Phone: 080-40838809 client’s processes and practices to ensure that quality, email: info@provenanceresearch.in Our mission timelines, and regulatory requirements are met. www.provenanceresearch.in “A vigilant today for a safe tomorrow” Total Pharmacovigilance Solution Provenance offers complete database services for PERIODIC REPORTS collecting, analysing and reporting adverse events supporting multiple studies or products. We utilize • Annual safety reports a fully validated, ICH E2B and 21 CFR part 11 • IND Annual reports compliant database that has multiple functionalities • Periodic safety update reports and supports SUSAR’s, ICSR’s, CIOMS I Reports, • Addendum reports MedWatch Reports, CIOMS Line Listings and • Bridging reports Tabulated Summaries. We can employ our • US Periodic reports comprehensive SOPs and engage dedicated resources to act as the drug safety department of your company. LITERATURE SEARCH • Running searches for literature on client Flexible Outsourcing Solution products from online bibliographic databases • Entry of identified cases into the safety database Provenance provides flexible outsourcing solutions • Literature searches for the purpose of inclusion COMPLIANCE to clients to meet their regulatory commitments. We in PSUR, evaluating safety issues and signals. can complement the client’s drug safety department by providing part pharmacovigilance services, or as and when needed services to meet their productivity metrics during periods with spike in volumes. We TRAINING SERVICES can work in the client’s safety database following their SOPs and work instructions helping them • Short-term training programmes in reduce their time and cost significantly. Be it ICSR Pharmacovigilance processing, Periodic reports, or literature search that • Certificate course in Pharmacovigilance you require, we can be your trusted safety partner. VIGILANCE