Pharmacovigilance and Safety

To address today's challenges, Aris Global has developed Total Safety — a comprehensive suite of integrated software solutions that enable life science organisations, regardless of status or size, to implement effective domestic and global pharmacovigilance, clinical safety, Signal detection and risk management programs.

agOnDemand™: Managed, hosted software for safety

agOnDemand™ is the managed, hosted software platform that enables all customers, regardless of size, to use any of Aris Global’s Total Safety™ software solutions on a subscription basis — without the investment in new software, hardware, or even new application and infrastructure support staff.

Key benefits:

• Offers the market-leading safety solution suite on a secure, proven, hosted platform
• Supports best-practice business processes in support of global compliance
• Eliminates upfront hardware costs and software license fees, delivering a rapid ROI
• Removes the need for internal IT and database administration support staff
• Provides an intuitive, easy-to-learn safety system, requiring minimal training
• Minimises ongoing maintenance, support and upgrade costs

ARISg™: Clinical safety and pharmacovigilance

The world’s leading pharmacovigilance and clinical safety system with more than 300 installations worldwide, ARISg offers unrivaled advanced software capabilities for managing adverse drug event reaction reporting.

Fully scalable, ARISg can be used by small operations in the early stages of clinical trials or large organisations with worldwide pharmacovigilance operations. A modular system, ARISg facilitates compliance with domestic and global safety reporting obligations for drugs, vaccines, biologics, devices and combination products.

Key benefits:

• Enables companies to reduce safety risk for multiple product types, including drugs, devices, vaccines and combination products
• Provides international safety reports for clinical and post-marketing surveillance
• Improves the case processing life cycle and reduces data entry time
• Automates case processing and report distribution with flexible workflows
• Allows ad hoc reporting and personalized dashboards with standard and user-defined metrics/KPIs
• Shortens the medical review and coding process
• Integrates with document management systems, Business Objects and clinical systems

ARISj™: Safety and pharmacovigilance for Japan

ARISj, a Japanese-language enabled system, is an extension of the market-leading ARISg pharmacovigilance system that is specifically designed to support the data capture and reporting requirements as defined by the MHLW. As such, the ARISj system supports all functions available within ARISg but extends the feature set with product features that are unique to Japan. Aris Global provides complete support for all MHLW requirements and ensures ARISj is constantly updated to ensure the system complies with the latest regulations.

Key benefits:

• Delivers a fully Japanese-language enabled pharmacovigilance system
• Provides complete support for integrated MEDRAj™ with embedded browsers and versioning
• Prepares MHLW-compliant expedited and periodic reports
• Creates comprehensive user and management reports, including full audit trail, compliance and case processing
• Fully supports Japanese hospital codes, products and clinical studies
• Offers advanced query and ad hoc reporting capabilities
• Deploys in either a centralised or decentralised environment
• Integrates fully with ARISg for global compliance

agSignals™: All-in-one solutions for querying, reporting, data mining and signal detection

agSignals is Aris Global’s advanced data mining and signal detection system that facilitates in-depth clinical safety data analysis and incorporates all relevant data sources. agSignals combines an optimised database with powerful front-end querying, reporting and analysis tools. It enables users to meet the demands of pharmacovigilance and risk management for their products, supporting rapid regulatory response to agencies while reducing lengthy and costly market uncertainty.

Key benefits:

• Creates standard and user-defined trending reports
• Analyses data using statistical algorithms
• Generates ad hoc reports for signal detection
• Can be connected to any source safety system
• Integrates with third-party visualisation tools
• Supports the creation of periodic reports, including PSURs and Annual Safety Reports

agComposer™: Periodic and aggregate report preparation

agComposer is Aris Global’s comprehensive periodic and aggregate reporting system that schedules, creates and tracks a full range of submission-ready, ICH-approved periodic reports, including PSURs, bridging reports and other annual reports such as the ASR. agComposer accelerates the preparation and timely submission of PSURs, including bridging reports and other periodic reports such as the ASR. agComposer can work seamlessly with any safety system to simplify the process of periodic report preparation.

Key benefits:

• Automates the authoring, editing and approval of content
• Sets deadlines and reminders automatically
• Provides a ten-period rolling scheduling facility based on reporting
• Locks data for current and future analysis
• Integrates with agSignals™ for benefit/risk analysis and assessment
• Meets reporting deadlines
• Improves collaboration between departments for creation of all report sections

agXchange™ ESM: Electronic Distribution

Aris Global® is the recognised leader in the implementation of the E2B standard for electronic communication of safety case data. Across the globe, more than 55 customers, including major regulatory agencies, rely on agXchange ESM for electronically exchanging safety data such as ICSRs, SUSARs, attachments, and periodic reports. agXchange ESM allows users to quickly, easily and securely transmit and receive electronic safety reports (E2B) to regulatory authorities and business partners on a global basis. The module manages and tracks all safety submissions and receipts in accordance with the complex regulatory reporting requirements. agXchange ESM allows the submission of differing content dependent on the receiver meeting local reporting obligations and also supports the creation of the MHLW J-Items, creating a truly global compliant solution.

Key benefits:

• Provides extended E2B for complete electronic exchange of information with partners
• Exchanges ICSR and SUSAR files with multiple trading partners
• Distributes backlog ICSRs, periodic ICSRs and attachments
• Distributes standard reports to non-E2B compliant authorities
• Supports local data entry
• Can be configured to third-party or proprietary safety systems
• Creates flexible mapping to support local authority requirements
• Generates notifications for system failures and basic data integrity checks

agXchange IRT™: Inbound receipt and triage of adverse event information

As part of the agXchange™ modular gateway for extended electronic exchange, the agXchange IRT™ module enables organisations to securely and efficiently receive adverse event information from diverse constituencies: affiliates, co-development partners, consumers, healthcare providers, CROs, and headquarters’ staff.

Key benefits:

• Enables timely and accurate receipt of safety information
• Supports multiple formats, including email with attachments, fax and E2B
• Provides flexibility to create custom data-entry forms
• Contains a built-in document management system (DMS), supporting versioning and storage
• Facilitates duplicate case checking
• Supports triage of AE information from a centralised location prior to full case processing
• Tracks internal and external communications
• Reduces processing and administrative costs for affiliates
• Improves inspection readiness through demonstrated local tracking system from receipt (IRT) to submission (OST)

agEncoder™: Central coding and dictionary management

agEncoder is a Web-based, centralized coding and dictionary management system, which codes verbatim terms (VTs) from different systems and maintains dictionaries at a central location. agEncoder automates the coding process and minimises any manual coding effort involved. Integration with ARISg and ARISj, Aris Global’s industry-leading pharmacovigilance solutions, enable companies to improve the consistency of trial safety reporting and reduce the efforts to reconcile serious adverse events.

Key benefits:

• Delivers a comprehensive and integrated centralised coding and dictionary management system
• Reduces costs with efficient, fast and accurate coding
• Enables standardisation of coding, process across the organisation
• Provides a flexible and configurable workflow to support the coding process
• Supports WHO Drug Dictionary, MedDRA (English/Japanese) and Japanese Drug Dictionary
• Supports easy and fast dictionary upgrades leveraged with impact analysis and decision-making
  capabilities
• Saves time and coding effort using advanced algorithms and synonym lists
• Integrates with ARISg and ARISj seamlessly

For more information please contact us.