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:

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:

WHODD Link Korea
ATCs
CRT Japan
EDQM
GMDN
IMDRF
MedDRA
MedDRA to SNOMED link
MedDRA to IMDRF link

Aggregate Reporting Module

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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