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Smarter PV on the Insife Cloud
The Insife.cloud platform is a one-stop-shop for pharmacovigilance (PV) technology and services that delivers a modern, flexible and open platform for clients to access to an integrated suite of PV-related technologies and applications from a range of partners.
The Insife.cloud allows the HALOPV suite, Insife’s global drug safety solution, to integrate seamlessly with other solutions such as the Axway Gateway for regulatory submissions to authorities, Amazon Web Service (AWS) business tools (such as AWS Translate and AWS Comprehend), clinical databases, and other drug safety systems.
Insife.cloud-based integration of HALOPV delivers a further set of tangible value gains, including automatic creation of PV reporting rules, Individual Case Safety Report (ICSR) intake and progress tracking, additional forms support (EU MIR device reporting, etc.), and aggregate report production using Word-based Templates. Integration of Argus Enterprise/OBIEE allows aggregate reporting in pharmacovigilance and statistical analysis or HiLIT option for signal detection and inclusion of external data sources across clinical and healthcare.
Cloud hosted PV advantages
The Insife cloud is based on best-of-breed technology – deployed in an industry standard way, and with annual upgrades included, to get maximum benefits at minimum costs / time.
Traditionally, system/tool providers compete to have similar technologies that carry different logos. In contrast, Insife has been working to select a number of different ‘best-in-breed’ vendors and make them work together to create an ecosystem of good practice and interoperability, we think you will benefit multifold from your investments. Among others, the Insife cloud provides ‘plug and play’ access to the following tools:
- HALOPV: Insife’s innovative drug safety system for managing PV processes across the global span of operations, enabling effective handling of any type of PV data, from ICSRs to PV agreements, regulatory intelligence and reporting rules, follow-ups and tracking submissions, PSPs/MRPs and social media scanning, risk management as well as CAPA tracking. HALOPV integrated seamlessly with databases and platforms such as Argus, ARISg, OneDrive / Sharepoint, Power BI, Axway and AWS services such as S3, QuickSight, Translate, Comprehend etc.
- Drug Safety Intelligence: The Drug Safety Intelligence API represents a new approach to capturing and processing ICSR data, delivering a streamlined and fully automated solution for integrating source information to finished E2B(R3) files with integrates to any R3 compatible safety database. When combined with HALOPV, it also allows AI confidence review screens that allows users to see data elements with low confidence, check and potentially correct the data.
- Axway B2B: The leading AS2 gateway technology for drug safety, Axway is an optional part of the HALOPV suite, for gateway E2b submissions to Authorities and partners. Insife.cloud offers an Axway solution for HALOPV, Oracle Argus or any other safety technology that need to send and receive E2B and acknowledgements via gateway.
Cloud-based Multivigilance approach
To overcome the challenges of global safety databases that are monolithic, outdated, overly rigid and provide decreasing client value, Cloud-hosted HALOPV provides possibilities to leverage creative automation, by providing an adaptable, modular and therefore scalable model with multi-level integration to meet the increasing need for a holistic ‘Multivigilance’ that goes beyond drug safety to integrate devices and data as well, opening up potential to apply IT automation, machine learning and AI across multiple channels and platforms.
The modular HALOPV approach also has the key advantage that it is easier to keep pace with the ever-increasing rise in caseload, currently increasing around 15 to 20 per cent year on year, as well as the pace of evolving regulations, with their emphasis on clinical data standardization and security. HALOPV and hosting via the Insife.cloud, delivers a technology blueprint to achieve a compliant, high-performing and effective PV safety system.
HALOPV Version 3.0 introduces a new user interface based on modern design principles and full safety database capabilities to achieve compliance with FDA, EMA and other global regulators.
It now offers HALOPV Data mart for advanced querying and full Safety Database capabilities that can operate either in standalone mode or in integration with any safety database. Insife pledges that HALOPV will remain fully open to integration with any vendor.
Integrated safety database and safety reporting
Full integration with Office 365 SharePoint or OneDrive environments allows users to generate documents directly from HALOPV records in workflow and share with multiple reviewers.
Further out-of-the-box integrations with Argus and ARISg, along with analytics tools such as PowerBI from Microsoft or QlikSense from Qlik, are also available for best-in-class data interoperability.
HALOPV’s functionality extends to a mobile-friendly representation, supporting ready global access, anyhow, anywhere. Meanwhile data security is enhanced by cloud hosted pharmacovigilance, placing HALOPV on Insife.cloud to provide a total one-stop-shop for pharmacovigilance drug safety and GxP compliance solutions. This allows companies to implement drug safety processes and regulatory submissions faster, more cost-effectively, and in smarter ways.