
HaloPV Modules
HALOPV consists of 19 modules that are all part of the same suite and work seamlessly together. It’s essentially a safety database, intake tool, reporting engine and signal detection suite and so on… all in one place!
Products Module
- Manage products based on families, products and market licenses. Capture information such as substances, NDA codes, IBD etc.
- Map products according to IDMP structures, i.e. setup Medicinal Product, Pharmaceutical Product, Device, Ingredients, Substances etc.
- Create Product index and associated synonyms to allow for coding and linking reported names to actual products
- Option to use as a standalone tool, or can also be integrated to e.g. RIMS (Regulatory Information Management System) or safety database
- Links to all other modules, in order to provide product information
- Link to PSMF module, to populate Annex H
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
- EDQM/Reference dictionary integration for:
- Substances (e.g. WHODD)
- Admin Routes (e.g. EDQM / WHODD)
- Pharmaceutical Forms (e.g. EDQM / WHODD)
- Sources / References (WHODD)
- ATC Codes (WHO)
- Rich import/export API
- Compatibility with xEVMPD / EU Art. 57
- Real-time index generation
- Event-driven coding updates
Clinical Trials Module
- Establishes a register of Clinical Studies and Clinical Projects, and manage their status over time
- Links with organisational Entities as Clinical Sites, Products as Investigational Products as well as Case Intake and Processing
- Integrates with an external safety database to ensure automatic transfer of safety data to HaloPV, enhancing pharmacovigilance and compliance efforts
- Can function as an independent platform or integrated with an existing Clinical Trial Management System (CTMS), depending on organizational requirements
- Can facilitate distributions to investigators including training materials, contracts, and other necessary documentation, ensuring they receive relevant updates and maintain compliance with regulatory obligations
- Links to the Pharmacovigilance System Master File (PSMF) module, enabling automatic population of Annex C/H or study lists. This integration ensures that documentation remains up to date, reducing manual workload and enhancing data consistency
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Organisational Entities Module
- Manage your global PV ecosystem of partners, affiliates etc. Or configure the organization to control the remit of departments in the application. The entity setup effectively controls the access to data across the entire platform
- Setup Authorities, Investigators, Committees etc. and use in other modules e.g. to auto-distribute SUSARs by linking with Clinical Studies and Submissions — or for ICSR regulatory submissions
- Link to PSMF module, to populate Annex A, B and C
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Case Intake and Processing Module
- Receive data from affiliates, partners, contractors, or even directly from costumers
- Integrate multiple email sources to easily receive information in one consolidated inbox
- Intake ICSR/Device Incidents/Combination Products information in structured AE forms or unstructured
- Leverage AI and automation to extract data from structured forms directly into database fields
- Automated document annotation to highlight relevant information in source document. Auto- reduction for protecting sensitive data
- Side by side view to facilitate comparing original source document with data entered into HaloPV
- Use AI for translation to and from local languages
- Easily integrates with your safety database or any other source systems for case reconciliation
- Enabling an accurate duplicate check early in the intake process
- Manage follow-up information requests quickly and easily directly from intake
- Integrate with other systems via standard API for seamless data exchange with partners, authorities, notified bodies, etc.
- Integrates with Submission module. Reporting rules are configured in Regulatory Intelligence in order to automate the report submission to authorities, notified bodies, partners etc.
Defective Medicines Module
- Receive reports from various sources > health care professionals, member of public, authorities
- Reports can be received via email, or integrated source system or user can manually create these records
- Information is taken into structured data forms
- Workflows are preconfigured for reviewing reports and creating safety alerts
- User can further escalate and communicate with different departments via email triggered from the system
- Send notifications to users when new report received, or action is required
- All documentation related to reports are stored in one place including emails
- Workflows can be integrated with other source systems or web platforms to publish safety alerts
Device Vigilance Module
- Intake device information from structured MIR forms or unstructured text from affiliates, partners/contractors — or even directly from consumers
- Manage device case processing in HaloPV, including site/manufacturers evaluations, IMDRF coding etc.
- Manage Clinical Investigation related SAEs in HaloPV
- Integrates to the Submissions module, to auto-generate a number of formats including MIR, eMDR, FDA combination products etc. This also allows for tracking the number of actual MIR reports sent out based on requirements (auto-scheduling available if Requirements Intelligence module is enabled).
- Reconcile device reports from local, clinical etc. sources with HaloPV
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
- Workflows for Trend Report, PSR, FSCA document review process
Literature Module
- Maintain information on literature monitoring and review, including listing of publication sources that are being monitored
- Schedule monitoring activities at central and local level, and track timeliness
- Automatically collect articles via Integration of literature sources, e.g. PubMed
- Invoke AI-based tools for translation into English and also perform Natural Language Processing, to expedite identification e.g. of relevant products, keywords and safety information extraction
- Out-of-the-box integration with HaloPV ICSR handling or other safety databases, e.g. Argus and ARISg via E2b(R3)
- Autocreation of ICSR records from relevant literature articles
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
- Mark articles based on relevance for signal detection, aggregate reporting or other PV processes
- Automated document annotation to highlight relevant information in source document
Signals Module
- Manage Signal Detection Plans, including signal detection schedules and tasks
- Compute quantitative signal detection statistics including PRR, ROR and EB05
- Maintain overview of observations and signals
- Review drug-event combinations (DECs) over time and include annotations
- Track all decisions and accumulated data over time, version controlled, audit logged and according to GVP Module IX
- Auto-generate Signal Assessment reports and tabular output for use in periodic reports using Word templates
- Link to Risks: promote a confirmed signal to a risk/safety concern
- Link to Global Requirements Intelligence: ensure global regulations are followed
Risks Module
- Manage your inventory of Risks (safety concerns) in one place, from registration, risk categorization, risk management strategies, related minimization measures, including local RMMs — and other activities
- Built around a powerful workflow engine that allows for the creation, review and approval of risk management documents
- Utilize MedDRA queries collections that are standardized across modules, to ensure that terms and medical concepts are assigned, reviewed and maintained against the risk
- Auto-generate core RMPs, local RMPs / REMS using formatted core and local Word templates with the capability to introduce controlled “Snippets” for non-core template text
- Monitor timeliness across all deliverables using built-in charts, including a Gantt overview of risk commitment activities
- Links with Signal modules for fully integrated signal & risk process
- Use in collaboration with Regulatory Intelligence to ensure that risk management activities are in alignment with global regulatory requirements
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Dictionaries Module
- Manage the Summary of Product Characteristics (SmPC), store and update the documents and create collections of terms in SmPC
- Create new CMQs or review SMQs
- Add lists of terms in collections for signal detection, aggregate reporting etc. e.g. Keep under review terms
- For ICSRs, you can use the label collections with an automator to auto-assessment event listedness
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
- The Medicinal Product Dictionary (Products Module)
- WHO Drug Dictionary integration
- WHO Drug Dictionary browser:
- Browse by Drugs
- Browse by ATC Code
- Browse by Standard Drug Groupings (SDG)
- WHODD Link Korea
- ATCs
- CRT Japan
- EDQM
- GMDN
- IMDRF
- MedDRA
- MedDRA to SNOMED link
- MedDRA to IMDRF link
Aggregate Reporting Module
- Maintain overview and produce various types of aggregate reporting from clinical to post-market – also locally - Built around a powerful workflow engine that will allow for the review, approval and management. Current out-of-the box reports:
- DSUR Line Listing
- DSUR Summary Tabulation (period/cumulative)
- PBRER Summary Tabulation
- SAE Line listing
- PADER including device malfunctions
- Five interactive report formats which can be customised to meet most business needs:
- Case per line
- Product-event per line
- Revision per line
- Submission per line (requires use of HaloPV Submission module)
- Activities per line
- Auto-generate documents, format using Word templates. Template based document creation but also with “text snippets” that allow controlled introduction of non-core template text
- Monitor timeliness across all deliverables, and utilize built-in charts including Gantt overview of activities
- Ability to save customized reports for re-use by users with designated user roles.
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Term Collections
- Term Collections are lists of terms from a single dictionary (WHO Drug, MedDRA and IMDRF), possibly spanning levels of the dictionary hierarchy
- Provide consistent querying and retrieval of cases, especially when a single term is not sufficient such as when capturing a particular safety concern
- Useful in representing special lists such as Designated Medical Events or Listed Events
- Robust support for assessing impact of new dictionary versions on existing collections
- Ability to detect duplicates and assess similarity across collections
PSMF Module
- Manage multiple PSMF (pharmacovigilance system master file) versions with separate contributors. Workflow for each annex — Built around a powerful workflow engine that will allow for the review, approval and management of any data point in the PSMF
- Configurable to local guidelines — and maintain multiple different versions of the Annexes, e.g. for EEA, France, CIS, India in the same application
- Removes the need for emailing of documents for review to affiliates and other stakeholders
- Allows ease of document generation — as no manual data collation is required, focus of review is on content
- Auto-generate annexes, format using Word templates. Template based document creation but also with “text snippets” that allow controlled introduction of non-core template text
- Management and selection of PSMF data from multiple sources and systems gives you complete and accurate information — Links to multiple modules: Entities and Agreements, Products, Clinical Studies, Data Collection Programs, Submissions, QMS
- Automates data gathering of Annexes
- Auto-generate Annex I (logbook)
- Maintains an audit trail for all changes and updates
- Use various pdf functionalities for headers/footers and merging of final document
- Is GxP validated* and ready to use in the cloud
Regulatory Intelligence Module
Maintain a centralized overview of global pharmacovigilance (PV) requirements across partners and regulatory authorities. It supports a wide range of requirement types, including:
- Regulatory guidelines and safety reporting (e.g., ICSR, SUSAR, PSUR, DSUR)
- PV system and system master file documentation
- Medical device reporting
- Local QPPV/Safety Responsible requirements
- Risk Management Plans (RMPs) and associated documents
- Signal detection and management
- Renewal documentation
- Data Monitoring Committee requirements
Key features include:
- Workflow-based Management: Local teams can update country-specific requirements, with configurable approval workflows (e.g., from headquarters)
- Automation & Integration: Requirements can automatically trigger actions in other HALOPV modules (e.g., Aggregate Reporting or Submissions), or generate rules in external systems like Argus Safety through integration
- Full Audit Trail: Every change is tracked for compliance and transparency
- Cloud-Ready & GxP Validated: Fully validated and compliant for cloud deployment in regulated environments
Data Collection Programs Module
- Manage data collection programs such as Patient Support Programs, Market Research Programs, Web sites etc. and distribute tasks locally or centrally
- Link data collection programs to partners and their agreements from the Entities module, to control access and monitor entity performance
- Schedule data collection program specific reconciliation activities, e.g. to ensure that ICSRs have been processed and reported
- Link to PSMF module, to populate Annex B and C
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Quality Module
- Maintain information on audits, e.g. plan, execution, reporting, both internal as well as external, create assignable findings/observations records and generate CAPAs and CAPA reports automatically
- Visualize actual CAPA effectiveness, if target process is also in HaloPV, e.g. observe number of process record tasks not timely in Complaints module in Sweden
- Track audit deliverables, create tables and graphs of performance e.g. findings per category
- Managing QMS documents, schedule and perform training by individuals
- Mange deviations / non-conformities and track timeliness
- Manage training records for staff, including timeliness tracking
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Agreements Module
- Manage PV Agreements (SDEAs) with partners, affiliates etc.
- Auto-generate SDEA documents, format using Word templates
- Snippets control standard clauses that can be selected for inclusion into the agreement
- Electronic signature allows for fully digital workflows, also with non-HaloPV users
- Link to PSMF module, to populate Annex A, B and C
- Link to the Requirements Intelligence module, to configure partner obligations
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Submissions Module
- Submit ICSRs to Authorities and other stakeholders seamlessly and via either automatic or manual workflows, as per reporting destination capabilities
- Manage compliance of all submissions via submission records. Manual submissions are managed in separate workflow, but compliance can be viewed, e.g. across all ICSRs, device reports, PSURs etc.
- Integrates with AS2 gateway, emails and “burn-links” for secure transmission
- Auto-detects late submissions and enforces a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations
- Link to requirements, use requirements to schedule activities and reversely i.e. track the number of actual submissions sent out based on requirements
- The Submissions overview screen allows for setting search parameters and filter for charting, tables and details for submissions to specific reporting destinations or per destination type e.g. Ethics Committees
- Integrates seamlessly with the ICSR (Safety Database) module or connect via API with Argus Safety, ArisG and Veeva Vault Safety, to allow for automatic creation of submission records in HaloPV
- Maintains an audit trail for all changes and updates
- Is GxP validated* and ready to use in the cloud
Data Mart
- Data Mart provides access to data from all other modules
- Data are normalized and decoded for easy use
- Connect your own preferred Business Intelligence solutions and create reports, dashboards, etc.
- Provides additional capability to expand the already rich reporting features available in HALO
- Provides a landing area for integrations with other systems
- Full or Incremental ETL
- Consistent snapshot
- Allows for generation of reports on large data sets without impacting the live HaloPV system
*Validation package provided with documented proof of execution of test cases according to Insife’s standard process configuration. Additional validation activities may be needed to satisfy the needs of your organization.
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