28 Apr 2025
A Top 25 global Japan headquartered pharmaceutical company selected PV Reports and PV Central after an extensive 14-month evaluation of products in the marketplace. This included a POC with hands on session for global users which was positive around user friendliness, compliance, and system maturity. The company is replacing the current Deloitte converge health reporting solution. Scope includes: PV Reports,...
28 Apr 2025
A Top 5 pharma was striving to stay ahead of regulatory changes and ensure compliance around the globe. As a result, Top 5 pharma is revising its technology strategy within Adverse Event Management, reporting and analytics, with a strong focus on future-state, innovative architecture, and technology. The goal of becoming a world-class drug safety organization that is prepared to meet...
28 Apr 2025
The company will replace their legacy system and move to RxLogix PV Signal for all signaling needs on internal and external data sources. More than 300+ Users Load company’s Internal Safety data into RxLogix PV DataHub using standard ETL process from company’s cloud to RxLogix Cloud Data review from external databases like FAERS and EVDAS Complex data migration included migration...
28 Apr 2025
The company is in early stage of drug development and utilizing RxLogix SIAB PV Platform and AI Technology will ensure capturing of Adverse Event Data and then reporting it to health authorities. End-to-end Implementation using RxLogix Fast Track Implementation Methodology Leveraged RxLogix Fast Track validation package to ensure in-budget delivery Hosted on RxLogix Cloud Platform by utilizing industry best practices...
28 Apr 2025
A Top 15 global pharmaceutical company was looking to implement a unified, integrated end-to-end Safety Platform to enable better management of safety activities with an increasing product portfolio through emerging technology (Cloud, Automation, AI/ML/NLP, and Hyperautomation). In addition, system goals will be automation of manual processes, enhanced monitoring and safety analytics, and a user-friendly interface. The drive was to address...
28 Apr 2025
The client is already in production with PV Reports, PV Central and PV DataHub for several years. Project included end-to-end implementation of PV Reports Japan solution. The project complexity was high as migrated Japanese case data needed to be augmented in an existing global PV Datahub. The project was executed successfully.
28 Apr 2025
It was a large project that included the following key systems and capabilities: PV Quality – New system implementation to monitor the PV case quality PV Reports Upgrade Implementation of Reporting Rate calculations in disproportionality algorithms based on imported drug sales/patient exposure data EVDAS auto-download utility PV Reports Japan - Two new reports (NUPR, SLL) Tech: Upgrade of Oracle 12C...
28 Apr 2025
RxLogix is already hosting their safety database and PV Reports application in RxLogix cloud. Through this deployment, the client extended the capabilities of self-service reporting, signal detection and management along with operational and compliance management. Project included implementation of the following modules: PV Central Implementation PV Signal Implementation Upgrade of PV Reports to the Latest GA release. The implementation of...
28 Apr 2025
RxLogix has successfully completed implementation of PV Reports, PV Signal, and PV Analytics SaaS solutions RxLogix’ AWS based cloud. The project was in support of a COVID vaccine client in order to be in compliance, deal with potential large volumes of adverse events, and eliminating manual processes. Some of the project highlights are as below: PV Reports Implementation included self-service...
28 Apr 2025
The project was a result of an extensive implementation to resolve several challenges. Following are some key areas of the project: Implementation of RxLogix SaaS platform in RxLogix’ AWS based cloud More than 300+ Users Unified Signal Management and Quality & Compliance Monitoring processes Complex Data migration included migration of alerts and signal histories Integrated safety review of data from...
28 Apr 2025
RxLogix PV Case Management will be used globally by the client users and their outsourced BPO/CROs users. The project scope included the following at a high-level: Implement RxLogix’ PV Case Management system Automation of 6 Complex and Very Long (150+ pages) Forms Key business features included: Automated business functions include but not limited to: Business Rules, Auto-Priority, Auto-Due Date, Auto-Categorization,...
28 Apr 2025
While we at RxLogix are still very happy about the award from Frost & Sullivan in December for being recognized for having the “Best-in-class Pharmacovigilance Solution, PV Intake and Processing”, only a month on we continue to innovate our solution. This month we can proudly announce the upcoming launch of the PV Intake Mobile App from April. PV Intake’s mobile...
28 Apr 2025
The RxLogix team has successfully completed Phase III of the Data Migration Project for madrid based pharma company. The project was to consolidate five separate entities into a single database hosted on RxLogix AWS Cloud. This was a highly complex project where the RxLogix team migrating existing legacy data from PcV Manager into the Argus Safety database with no documentation...
28 Apr 2025
PV Signal is replacing client's STAR (Empirica) system for Signal Detection. An extraordinary achievement for the entire client and RxLogix team. This was planned as an On-prem implementation but was moved to RxLogix SaaS just before UAT. The modules mentioned below will be used by ~140 users. All the users were trained within 1 month with 4 sessions /per user....
28 Apr 2025
PV Intake 4.7 was a major release, with new features & functionalities as follows:- Migration of PV Intake from client’s AWS Cloud to RxLogix SaaS platform hosted on AWS Automated case assignment based on workflow and user group Seamlessly integrated data quality check with f/u queries Multiple enhancements to support processes and compliance such as for FDA Combo Product Automated...
28 Apr 2025
RxLogix is one of the first companies to implement new Korea guidelines as a Korea MFDS solution in PV Intake & Processing (PVIP)
28 Apr 2025
Global CRO selects PV Signal, PV Reports, and PV Analytics for signal detection reporting and analytics for a COVID vaccine company. The CRO which is focused on providing services primarily for Pharmacovigilance and Medical Information to pharmaceutical and medical device companies, recently acquired the contract to conduct safety services for a biotechnology company’s COVID vaccine. They are expecting approximately 400,000...
28 Apr 2025
A top global CRO has selected PV Intake to automate the case intake for a large global pharma. This CRO provides full services to take clients assets from concept to compound to cure. The CRO has manual case entry and translation processes which required the addition of resources to keep up with increasing caseloads. This was a cause for increased...
28 Apr 2025
The project scope: Automate compliance and quality metrics currently tracked and managed by the Compliance and Quality team. RxLogix COTS products – PV Central and PV Quality will automate a highly manual process, minimize compliance risk, and save months of time it used to take our client to take appropriate corrective and preventive actions (CAPAs). The current process involved transcription of huge...
28 Apr 2025
Project Highlights: Global system with over 500 users Multiple PV modules in production: PV Intake & Processing PV Reports PV Signal PV Analytics PV DataHub RxLogix AWS based SaaS platform
28 Apr 2025
A mid-sized global biotechnology company dedicated to revolutionizing cancer care is replacing its current signal management in-house tools and processes. They currently utilize spreadsheets and various tools and applications in a largely manual process to meet signal tracking and reporting demands. They are deploying PV Signal to drive compliance and provide oversight to meet regulatory requirements. They chose PV Signal...
28 Apr 2025
Project included upgrade of PV platform as well, highlights are: Korea E2B R3 Pilot with MFDS followed by production Go-live PV Intake & Processing Upgrade to v4.8 PV DataHub Upgrade to v5.0 PV Reports Upgrade 5.0 PV Signal Upgrade 5.1
28 Apr 2025
Big Congratulations to the entire team at RxLogix Corporation on making the 2021 Inc. 5000 list – truly an impressive accomplishment! We look forward to the higher levels, and the responsibility that comes with it.
28 Apr 2025
RxLogix is excited to announce the expansion of our relationship with one of the fastest growing biotech, focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. In the month of July RxLogix successfully took our client live on Argus J. It will enable the client’s Japan teams...
28 Apr 2025
Global CRO selects PV Signal, PV Reports, and PV Analytics for signal detection reporting and analytics for second COVID vaccine company. The CRO is focused on providing services primarily for Pharmacovigilance and Medical Information to pharmaceutical and medical device companies, recently acquired the contact to conduct safety services for a biotechnology company’s COVID vaccine. They are expecting approximately 200,000 adverse...
28 Apr 2025
RxLogix is pleased to announce that a Top 15 global company that manufactures and markets pharmaceutical products has selected to implement RxLogix integrated, end to end Safety platform. RxLogix’ PV DataHub, PV Intake & Processing, PV Signal, PV Reports, PV Analytics, PV Central, PV Quality and PV Gateway will be implemented to address Next Generation Safety requirements. Almost all of...
28 Apr 2025
The PV Signal solution has been selected by another world’s Top 5 Pharma to address their next generation signaling requirements. Project scope includes but not limited to the following items: A new highly complex and advanced increased frequency algorithm Qualitative and quantitative signal detection Ad-hoc data mining to include more flexibility Advanced capabilities to manage Safety Lead review process and...
28 Apr 2025
RxLogix is pleased to announce that a local Japanese company selected PV Signal for end-to-end Signal Detection, Analysis and Management capabilities. The selection was made after a market scan of options, RFP, and review of proposals. PV Signal will be deployed with internal data from ArisG LSMV Safety and on external data sources including FAERS, EVDAS, and JADER. The client...
28 Apr 2025
A leading sponsor has gone live on PV Case Management. The client replaced its existing AE Reporting system with PV Case Management with around 125+ users. The project was a result of an extensive implementation to resolve a number of challenges. Data Sources that were automated are: CIOMS MedWatch Case files containing AE’s inclusive of patient data, medical history, product,...
28 Apr 2025
RxLogix is pleased to announce that a leading COVID pharma company and provider of other therapies for the prevention and treatment of infectious diseases, has selected PV Signal, PV Reports and PV Analytics. The client was seeking a state-of-the art technology solution that would deliver a framework that supports integrated pharmacovigilance solutions to address signal detection and management, PV reporting,...
28 Apr 2025
Another Top 10 pharma headquartered in France selects RxLogix for implementation of a new Reporting Environment supporting Pharmacovigilance business needs for: Standard Reports including Periodic Regulatory Reports (PBRER, DSUR, PADER, Japanese periodic reports) Ad-hoc Reports Interactive Dashboard Compliance Monitoring Quality Tracking Interfaces for downstream applications This will be a very large project with solution hosted in RxLogix AWS Cloud with...
28 Apr 2025
FDA is live with the FAERS II program. The Center for Drug Evaluation and Research (CDER) & Center for Biologics Evaluation and Research (CBER) divisions at the U.S. Food and Drug Administration (FDA) are responsible for protecting the public health by ensuring the safety, efficacy, and security of human drugs and biological products. To perform state-of-the-art data analytics and signal...
28 Apr 2025
Biopharmaceutical company will go with RxLogix entire case management offering inclusive of the following RxLogix products: PV Case Management PV Gateway for electronic submissions PV Reports Aggregate Reporting PV Central for late case monitoring The company selected RxLogix PV Case Management Platform after a thorough evaluation inclusive of specific use cases including both AE forms, xml downloads, literature and bulk...
28 Apr 2025
Our new partner company develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients for neurological disorders, oncology and respiratory diseases. The company’s products are marketed in over a hundred countries, and the Group's own human pharmaceuticals sales organization covers all key European markets and a few Southeast Asian countries. In other markets the company’s products are sold...
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