While working with our industry-leading clients -- discovering and anticipating their pharmacovigilance needs -- Accenture invested in the development of a next-generation technology solution, INTIENT Pharmacovigilance. Explore our library of insights, thought leadership, and the latest topics & trends in healthcare. Contact us about clinical research and pharmacovigilance. Built-in Argus automation featuresfor intake, case prioritization, field validations, letters, action items, coding, listedness, narratives, case lock, submission, and archivingcan reduce manual work by 50% or more. Oracle Argus incorporates E2B(R3), eVAERS, eMDR, and J-DSUR reports and integrates with the Oracle B2B for EDI gateway. Expertly manage rapidly increasing caseloads and changing regulations. Contact us about clinical research and pharmacovigilance. IQVIA provides flexible, innovative, scalable solutions to meet your unique business requirements. Learn about the four critical trends pharma and med-tech organizations are embracing related to digital transformation. The key to your success is implementing automation, adopting advanced technologies, and leveraging insights from analytics that improve compliance and product safety. Join our live thought leader-hosted events and watch on-demand sessions. Purpose: Pharmacovigilance (PV) is a relatively new discipline in the pharmaceutical industry. Check the spelling of your keyword search. Standard Operating Procedures in Pharmacovigilance - ClinSkill Automate safety-signal detection with proven algorithms developed by world-class statisticians and data scientists. For clinical trial pharmacovigilance/drug safety surveillance services, Everest uses Oracle Argus as the primary safety platform. Pharmacovigilance is the science of monitoring and assessing the safety, efficacy, and quality of drugs through pre-marketing clinical trials and post-marketing surveillance. Session 6.1 - Case Processing of Spontaneous Case in Argus Safety Use this to know how to use the application for analysis and reporting in medical product safety and pharmacovigilance and how to install or upgrade the application and database. Thorough collection and assessment of product safety information is essential to the success of clinical research studies and to maintain post-marketing product licenses. Additional services include literature searches (Elsevier Embase) and input to signal detection. We understand the need of customers to have oversight and feel confidence in the quality of their safety data and as such we offer the flexibility to choose a full, end-to-end case processing solution, or a hybrid approach where customers can be involved in the case processing workflow such as final quality or medical review. While pharma has traditionally seen the pharmacovigilance process as a cost center, its now a foundational component for any organization. Oracle Argus Training and Certification | Oracle University Supporting the entire pharmacovigilance journey. Pharmacovigilance Training in Oracle Argus Safety Database - SlideShare Gratisol Labs provides an in-depth training to the learners to accelerate their knowledge and . We have a truly global clinical pharmacovigilance footprint through a presence in more than 100 countries and operating from offices in the United States, Europe and Japan. Each customer has their owned unique database instance, which allows secure and controlled access to customer-specific safety data and efficient maintenance of the system. Having a database with all the bells and whistles including functionality you may never use, multiple complex and branching workflows for every type of case and dedicated data fields to capture every possible data type may seem like a good idea at first, but such systems can be difficult to validate, time-consuming to maintain and perhaps most importantly, very complicated to use, these systems may also prove problematic down the line with migration of data into or out of the database and with upgrades.It is also worth bearing in mind that software vendors routinely market their systems as being compliant with all the latest regulatory requirements such as E2B-R3 compliant and CRF 21 Part 11 complaint but in reality, compliance with such regulatory standards comes only with careful setup, validation and management of the system as well as correct entry of case data. Download the Oracle Argus Safety Training PDF here Oracle Argus Training and Certification Oracle Argus Safety Certification We have more than 1,200 dedicated pharmacovigilance resources, including 60 physicians and 45 medical writers, who are helping our clients process 1.5 million cases annually. Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety and quality. In this video, 4C Pharma COO Muhammad Ahmad discusses the company's strong partnership with Oracle Health Sciences, focusing on how they use Oracle Argus to support their customers and why they chose to use Argus above all other Safety products. Transform your PV activities TODAY by deploying these AI-driven automation tools. Lifecycle safety expertise enhanced by AI/ML, New Solution Builds On Optical Character Recognition To Extract SAE Form Data. Argus was greek mythical giant with 100 eyes who was assigned by Zeus wife (Hera) to keep a vigilant watch of Zeuss lover (Io) who had been turned into a cow. Empower business users, data engineers, and data scientists to process relevant data, evaluate predictions, and make quick, accurate decisions. Canada L3R 0B8, Accessibility | Privacy | Disclaimer | Sitemap | Web Design By Silentblast, Biostatistics and Statistical Programming, Clinical Project Management and Operations, Clinical Pharmacology and Drug Development, Electronic Regulatory Submission (eCTD) Tools and Processes. From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution. Supports all product types: Drugs, devices, vaccines, biologics, and gene therapies 2. We have vast experience in safety data migration from legacy systems. Reaping the benefits of artificial intelligence in life sciences will depend on the human workforce. It is the Gold standard for Pharmacovigilance and is used to manage millions of Cases in the industry. The path to 360 value starts herefeaturing our most provocative thinking, extensive research and compelling stories of shared success. Our pharmacovigilance business is one of the largest groups of PV experts worldwide, with a combination of deep life sciences expertise and best-in-class technologies. Our experienced team are able to use these systems (subject to completion of training and SOP requirements) to process cases and report ICSRs and generate outputs for period reporting and signal/risk management activities. We could not find a match for your search. Argus Cloud, the industry's best-in-class platform for safety and pharmacovigilance regulatory compliance, offers a scalable and secure solution within a . NetForce acquisition and Argus and Empirica advancements. The masking effect, a statistical issue, and how to handle it are also covered. Clinical Project Management and Operations At Accenture, our expert teams in operations, technology and consulting support the entire pharmacovigilance journey, from proof-of-concept to end-to-end services. The key to success is understanding how the various types of automation function and where they it into the overall process. SafetyEasy comes with inbuilt query and reporting functionality providing validated outputs designed for expedited and periodic reports as well as signal detection and case management. Rave Harpaz, combining the advantages of the MGPS and ELR algorithms into one hybrid method. Types of Pharmacovigilance Softwares - Sollers College The APVASC is the most preferred pharmacovigilance certification program by recruiters across the industry. Pharmacovigilance and Drug Safety Solutions - IQVIA So why arent pharma companies leveraging the power of these AI-driven platforms, Transform Pharmacovigilance with Automation, How automation and machine learning are transforming Pharmacovigilance. CCRPS offers pharmacovigilance training in oracle argus safety database. Argus and Empirica are among the first safety case management and signal management solutions, helping end pharmacovigilances reliance on paper and ushering in the use of digital technology in the industry. Oracle acquires Relsys for its pharmacovigilance capabilities, and Argus becomes an Oracle product. All rights reserved. Quanticates safety databases are validated and continuously maintained to regulatory standards thus avoiding the considerable costs of implementing, maintaining and upgrading inhouse systems. Oracle Argus is a comprehensive pharmacovigilance platform which enables pharmaceutical manufacturers to make faster and better safety decisions, optimize global compliance and easily integrate risk management. You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR(R2), MIR, and IDMP. We rely on technologies like Oracle Argus Cloud to help ensure that we are making safety decisions, reduce risk, and help ensure global complianceso that we can focus on delivering therapies that will improve the quality of life of patients., Michael McCann, Global Vice President of Sales, Alliances, and Channels. Argus 3 is released as a web application and adds the E2B (R2) report, an affiliate module, and a Japan module. Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. Nearly every process in safety and pharmacovigilance can be automated. Aris Globals LifeSphere Safety (otherwise known popularly as ARISg) is another market-leading pharmacovigilance database with a long and well-established heritage in the industry. What if you could alleviate this pressure on multivigilance activities, while improving efficiency and strengthening compliance? . East Tower, 4th Floor