The most advanced and comprehensive safety system for all your PV needs
HALOPV
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HALOPV is a game changing platform, with a unique subscription model, that will revolutionize your PV System with comprehensive and integrated modules for end-to-end Pharmacovigilance. Its new features will transform the way that companies can manage their PV processes and promises to create a unified ‘Integrated Universe’ that all pharma companies can enjoy, regardless of their size.
Equipped with industry standard out-of-the-box workflows, HALOPV streamlines your processes from day one, enhancing efficiency and productivity. It's AI enabled capabilities bring intelligent automation to the forefront, empowering users with advanced features like automated translation, content creation and the ability to extract data from structured and unstructured source documents.
Don’t want to change your existing safety database? No problem! HALOPV seamlessly integrates with Argus and various other safety databases, to ensure seamless data exchange and interoperability.
With millions of cases already being processed, HALOPV has demonstrated its scalability and reliability in handling extensive datasets. Moreover, its zero percent carbon emissions underscore Insife's dedication to sustainability and environmental responsibility.
‘No man is an island. This system will unify pharma. It will make it easy to not just operate on your own, but to operate with all the partners that you need across the world, and to do it simply and quickly on an affordable platform for all. That’s HALOPV!’
Martin Holm-Petersen, CEO, Insife
HALOPV is a trusted solution and is being used by many varied and diverse organizations, including several top 20 pharmaceutical companies, regulatory agencies, CROs and service providers, small to mid-sized pharmas and biotechs.
Trusted and Proven Technology
At Insife, we don’t reinvent the wheel – we use the latest AWS cloud-based SaaS solutions that leverage integrated AWS and Spark AI tools.
This enables us to provide accessible intelligent automation solutions like translation, natural language processing and data extraction.
"Best of breed" AI and Automation
Unique ‘pay-as-you-go’ pricing model means you can start for FREE and only pay for what you use.
Transparent pricing available on the website.
Affordable and Transparent Pricing
Multi-tenant for all 20 PV modules making HALOPV unique in the marketplace.
All modules are included in the subscription price and can be activated or deactivated as needed.
HALOPV is a rapidly available solution, just sign up and get access to your FREE account with pre-configured workflows.
Multi-tenant
Includes 20 fully integrated PV modules providing a solution with a single source of truth (SSOT) for your safety data.
Easily integrating with other safety databases by leveraging REST APIs, HALOPV stands out as the most highly comprehensive and integration-friendly solution on the market.
The PV ‘integrated universe’ will provide simple ways to exchange and share data between HALOPV users with collaboration spaces available for joint projects.
Comprehensive and Integrated
Fully GxP compliant and provided with a full validation package.
Built-in management of reporting requirements and compliance tracking including KPIs and CAPAs.
Insife is dedicated to providing sustainable (carbon neutral) and environmentally friendly solutions to contribute to your company’s environmental policies.
Compliant and Environmentally Responsible
With 20 different modules to choose from, HALOPV provides the tools to manage all multi-vigilance processes from operational to scientific. The joy of HALOPV is that it allows companies to start with whichever of the 20 modules that they required specifically for their business, creating a bespoke platform for each customer, then later expand as and when needed, removing the need for the ‘big bang’ approach.
Data Exchange
Our comprehensive technology solutions have been helping industry-leading companies and regulatory agencies for years. With HALOPV, you can achieve greater success faster, as this enterprise-grade technology is now available for everyone. It's that simple.
Start for free and only pay for what you consume – records, user accounts, environments. Pricing includes access to all modules.
Enterprise-grade technology available to everyone
MICRO
20 PV modules
Up to 50 records
1 user account included
1 production environment included
FREE
SMALL
20 PV modules
Up to 500 records
2 user accounts included
1 production environment included
EUR 500 per Month
MEDIUM
20 PV modules
Up to 5,000 records
4 user accounts included
1 production environment included
EUR 1,500 per Month
LARGE
20 PV modules
Up to 50,000 records
10 user accounts included
2 environments included
EUR 4,000 per Month
X-LARGE
20 PV modules
Up to 500,000 records
20 user accounts included
2 environments included
EUR 6,500 per Month
UNLIMITED
20 PV modules
Unlimited records
30 user accounts included
2 environments included
EUR 10,000 per Month
MICRO
20 PV modules
Up to 50 records
1 user account included
1 production environment included
FREE
SMALL
20 PV modules
Up to 500 records
2 user accounts included
1 production environment included
EUR 500 per Month
MEDIUM
20 PV modules
Up to 5,000 records
4 user accounts included
1 production environment included
EUR 1,500 per Month
LARGE
20 PV modules
Up to 50,000 records
10 user accounts included
2 environments included
EUR 4,000 per Month
X-LARGE
20 PV modules
Up to 500,000 records
20 user accounts included
2 environments included
EUR 6,500 per Month
UNLIMITED
20 PV modules
Unlimited records
30 user accounts included
2 environments included
EUR 10,000 per Month
Get started with HALOPV today
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For pricing in non-EUR currencies please contact us at hello@insife.com
• Manage global PV ecosystem and configure organizational control.
• Establish authorities, investigators, committees, etc., utilized across modules.
• Enable electronic signatures for digital workflows.
• Link to PSMF module for Annexes A, B and C population.
• Register and manage clinical studies with status tracking.
• Automatically link investigators to relevant sites and assign tasks.
• Integration with external Safety database for automatic data transfer.
• Compatible with existing CTMS or standalone operation.
• Includes options for additional investigator distributions like training and contracts.
• Links to PSMF module, for Annexes C, H or Study list population.
• Full product management: drugs, vaccines, e-cigarettes and devices.
• Manage products by families, products and market licenses.
• Map products according to IDMP structures.
• Generate a product index with synonyms.
• Standalone or integrable with RIMS or safety database.
• Links to all other HALOPV modules.
• Links to PSMF module for Annex H population
• Intake and process costumer complaints.
•Trigger investigations at production sites, etc.
• Track investigation progress and link to Case Processing module for new ICSRs.
• Maintain company-specific or IMDRF problem codes.
• Integrate with external systems via API.
• Link to QMS module for deviations and CAPAs.
• Manage costumer feedback and conduct follow-up queries.
•Seamlessly integrate with intake process.
•Receive and structure quality case data for efficiency.
•Utilize AI for narrative translation.
•Integrate with Submissions module for report generation.
•Process various product cases.
•Automate workflow steps to remove manual tasks.
•Automatically assign cases based on user availability.
Assign staff expertise levels for efficient onboarding.
•Receive data from various sources.
•Integrate multiple email sources into one inbox.
•intake ICSR info in structured forms or unstructured text.
•Utilize AI for data extraction into database fields.
•Compare documents with HALO data.
•AI translation for local languages.
•Integration with safety database for case reconciliation.
•Manage follow-up requests directly from intake.
•Intake device info from structured MIR forms or unstructured text.
•Manage device case processing, including evaluations and coding.
•Integrate with Submissions module for multiple report formats.
•Track actual MIR reports sent out.
•Reconcile device reports from various sources with HALOPV.
•Maintain literature monitoring sources.
•Schedule and track monitoring activities.
•Automatically collect articles from sources like PubMed.
•Utilize AI for translation and Natural Language Processing.
•Annotate articles to highlight relevant info.
•Integrate with Intake and Case Processing modules for ICSRs.
•Integrate with other safety databases via API or E2b(R3).
Base Modules
Case Processing
•Browse and search multiple dictionaries.
•Multi-language dictionaries available.
•Store up to 10 past versions of each dictionary.
•Manage Summary of Product Characteristics (SmPC), documents and term collections.
•Create or review CMQs /SMQs, add or remove terms.
•Create product groupings for reporting or signal analysis.
•Add term lists for signal detection, reporting, risks, etc.
•Use label collections for automated event assessments in ICSRs.
•Centralize risk components from registration to management activities.
•Auto-generate RMPs / REMS format using Word templates.
•Template based document creation with “Snippets”.
•Built-in charts including Gantt overview.
•Monitor timeliness of deliverables.
•Link to Signal Management for risk monitoring.
•Link to Requirements Intelligence for regulatory adherence.
•Link to Dictionaries & Terms for term associations.
•Tracking and schedule signal management.
•Conduct periodic and ad hoc detection activities.
•Manage schedules and capture data.
•Version controlled and audit logged, aligned with GVP Module IX.
•Generate reports from ICSR data or 3rd party tools.
•Auto-generate Signal reports using Word templates.
•Template based document creation with “Snippets” .
•Link to Risks for signal promotion.
•Link to Requirements Intelligence for timely handling.
•Maintain and generate aggregate reports from clinical to post-market.
•Out-of-the box reports available.
•Auto-generate report documents using Word templates.
•Template based document creation with “Snippets”.
•Monitor reporting schedule with built-in charts.
•Link to Requirements Intelligence for regulatory alignment.
Regulatory & Science
Oversight & Quality
•Manage data collection programs (e.g. Patient Support Programs, Market Research Programs).
•Distribute tasks locally or centrally.
•Link programs to partners agreements for access control and compliance monitoring.
•Schedule reconciliation activities to ensure ICSRs processing.
•Link to PSMF module for Annexes population.
•Maintain global requirements overview.
•Support multiple requirement types.
•Workflow-based management allows local officers to handle country requirements, followed by QPPV or HQ approval.
•Configured requirements can auto-schedule to other HALOPV modules.
•Alternatively, auto-generate reporting rule updates in Argus Safety via API.
•Manage multiple PSMF versions with separate contributors.
•Built-in workflow for Annex review and approval.
•Auto-generate Annexes using Word templates.
•Template based document creation with “Snippets”.
•Manage PSMF data from multiple sources.
•Links to multiple modules for Annex data.
•Auto-generate Annex I (logbook).
•Utilize PDF functionalities for document merging.
•Maintain audit information: planning, execution, internal & external reporting.
•Create assignable findings and observations records.
•Generate CAPAs and CAPA reports automatically.
•Visualize CAPA effectiveness in HALOPV.
•Track audit deliverables and performance.
•Manage QMS documents.
•Mange deviations and track timeliness.
•Manage staff training records and compliance.
•Manage Agreements with internal or external entities.
•Auto-generate SDEA documents using Word templates.
•Use "Snippets" for standard clauses.
•Electronic signature enables digital workflows.
•Link to PSMF module for Annexes population.
•Link to the Requirements Intelligence module for partner obligations.
Data Exchange
•Manage communication with stakeholders.
•Retrieve emails directly into HALOPV inbox.
•Construct and send responses within the module.
•Use templates for response documents.
•Track all communication and approvals, including timelines.
•Include electronic signature for digital workflows.
•Maintain a GxP archive for external interactions.
•Manage submission compliance across all records.
•Separate workflow for manual submissions.
•Integration with secure transmission methods.
•Auto-detect late submissions and enforce compliance.
•Utilize Requirements Intelligence for scheduling and tracking.
•Filter and search submissions based on parameters.
•Integrate with major safety databases for automatic record creation.
Get started with Insife today
Want to know more, get a demo or take it for a test drive?
We would love to tell you more and answer any questions you have, take you through a demo or let you test the system so you can explore yourself. We look forward to working with you.
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