ArisGlobal is the most renowned provider of drug safety and risk management software and solutions. They provide the most suitable pharmacovigilance and risk management solutions to pharmaceutical companies.
Drug Safety And Risk Management Software By ArisGlobal. RTSM (Randomization and Trial Supply Management) - ArisGlobal. Medical Coding Software From ArisGlobal. Best Drug Safety System - ArisGlobal. Pharmacovigilance and Safety Pharmacovigilance (PV) involves the receipt, triage, data entry, coding, medical assessment, distribution, aggregate reporting and archival of AE data and supporting documentation.
Historically, due to regulatory focus on expedited reporting of individual case summary reports (ICSRs) most pharmacovigilance (PV) departments have focused on the time consuming process of case management, with two leading case processing systems emerging in Oracle ArgusTM and ARISgTM. More recently, regulatory agencies have focused their priority on the areas of signal detection and risk management.
This shift in focus mandates proactive and reactive analysis of a product’s risk benefit profile, beyond ICSR processing alone. Concurrent to increased regulatory demands, greater patient awareness means the industry as a whole is experiencing a significant increase in the volume of adverse event reports. LPV is designed to work with your legacy case processing system. Best Medical Dictionary Software By ArisGlobal.
Identification Of Medicinal Products (IDMP) - ArisGlobal. Key Features/Benefits: Provides full compliance with the ISO IDMP standard Allows the import and cleansing of raw data from different sources or can work with an MDM solution Supports workflow driven process for enrichment and verification of compiled information Acts as central source of product information throughout the organization Provides webservices and standard connectors to integrate with 3rd party systems Supports the electronic submission of IDMP data Background As a continuation of the current xEVMPD mandate (Article 57), the European Medicines Agency (EMA) is in the process of defining and implementing new standards based on the ISO standard for the identification of medicinal products (ISO IDMP).
The challenge for the industry however is more than the evolution of xEVMPD. Although the deadlines for the compliance mandate are not yet finalized, it is clear that with the size of the challenge at hand companies need to start working on this now. agIDMP™ Clinical Trial Disclosure - ArisGlobal. Key Features/Benefits Manages all registrations from a single platform Ensures compliance with global clinical trial regulations Ensures data consistency across multiple registries Allows reuse of data across multiple registries Provides built-in flexibility for fast implementation of new regulatory requirements and registries Automatically updates with the newest versions of registries Out of-the box validation rules for many registries, including ClinicalTrials.gov and EudraCT Flexible database structure and business rules adapt to future requirements without coding Data can be imported from any CTMS.
Clinical Trial Data Management Software (CTMS) By ArisGlobal. Background Every clinical trial requires close collaboration between many departments, which often results in the deployment of a wide range of supporting systems that are rarely integrated.
Yet the deployment of diverse clinical systems from different vendors, using different technology, can create a disconnect within clinical development, making it difficult to ensure compliance and achieve a complete overview of all clinical activity and progress. agClinical™ - Clinical Trial Management System agClinical™ is a comprehensive and versatile clinical trial management system (CTMS) that enables life science organizations to plan, track and control all tasks and activities related to the set-up, conduct and closeout of clinical trials.
Automated Study Set-Up Study set-up is facilitated by automating many core activities such as study planning, site assessments, investigator selection, enrollment planning, document distribution and site visit planning. Streamlined Study Conduct. Electronic Trial Master File (eTMF) - ArisGlobal. Key Features/Benefits Maintains visibility, status and control of trial documentation Improves readiness for audits and inspections Enables faster and more efficient site setup and initiation Ensures file structure and organization quality with support for the DIA TMF Reference model Delivers significant time and labor cost savings compared to paper-based TMF approach Streamlines key business processes through integrated workflows Enables easy search, retrieval, reporting and status overview of documents Fully integrated with CTMS and investigator portal solutions Background Providing controlled access – storing, organizing and tracking — to thousands of essential clinical trial documents is no easy task.
AgFileMaster™ agFileMaster™ serves as the centralized, global repository for managing, organizing, storing, accessing and archiving all trial-related documents. Full document management is combined with clinical trial logic to support the complete lifecycle of each document. Regulatory Information Management System Software By ArisGlobal. Background Regulatory affairs (RA) involves more than managing submissions and license applications.
In reality, RA is focused on the tracking and management of the entire regulatory process to ensure that all products are developed, manufactured, licensed and supplied in accordance with the product license, approved manufacturing specifications and global regulations. All of this while optimising the use of scarce resources.