HALOPV Modules

HALOPV consists of 20 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
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 Studies Module

Setup a register of clinical studies and manage status
Link to Sites entities, to automatically identify investigators linked to relevant sites and initiates tasks for each investigator to e.g. pickup files such as SUSARs
Integration with external Safety database – Information is automatically transferred to HALOPV
Option of integrating with existing CTMS (Clinical Trial Management System) or run as independent system
Option to include other distributions for investigators such as training, contracts, etc.
Link to PSMF module, to populate Annex C/H or Study list
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 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 information in structured AE forms or unstructured text
Leverage AI and automation to extract data from structured forms directly into database fields
Compare original source document with data in HALO
Use AI for translation to and from local language
Easily integrates with your safety database for case reconciliation, enabling an accurate duplicate check early in the intake process
Manage follow-up information requests quickly and easily directly from intake

Case Processing Module

Intake ICSR information in structured forms or unstructured text from affiliates, partners/contractors — or even directly from consumers
Works for clinical, post-marketed and solicited sources
As a Safety Database, perform case processing in HALOPV including all relevant fields for global compliance across EMA GVP Module VI / FDA / Health Canada / MHRA / NMPA / MFDS requirements, including advanced auto-coding / assessments — or integrate and transfer from your previous/existing Safety Database, .e.g. Argus Safety or ARISg
Use AI translation for e.g. narrative transformation to and from local language
Integrates to the Submissions module, to auto-generate a number of formats including E2B(R3), E2B(R2) including Combination product reporting. This also allows for tracking the number of actual ICSR reports sent out based on requirements (auto-scheduling available if Requirements Intelligence module is enabled).
Reconcile ICSRs from local, clinical etc. sources with the ICSR (Safety Database) module
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

Complaints Module

Intake and process customer complaints via case screens
Trigger investigations at various entities, such as production sites. Track progress and link to ICSR module to initiate new ICSRs / device vigilance cases when identified that complaints is also an ICSR
Maintain and assign own problem codes and/or utilize IMDRF codes
Integrate with external QA / call center systems via API
Link to QMS module / or externally via API, to initiate new deviation / CAPA
Manage feedback loop with customers and conduct follow-up queries
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

Device Vigilance Module

Intake device information in 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, ÍMDRF coding etc.
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

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)
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

Signals Module

Maintain overview of observations and signals and track all the decisions and accumulated data over time, version controlled, audit logged and according to GVP Module IX.
Manage signal detection schedules and create Signal Detection Plans
Built-in quantative signal detection algorithms / views, to analyze drug-event combinations (DECs) over time and annotate cases. Go directly to ICSRs of interest for further analysis. Or can integrate with 3rd party detection tools, e.g. Commonwealth Vigilance Workbench or BI
Ability to pull in multiple datasets, including "internal data" from Safety Database (see ICSRs module), OpenFDA, EVDAS - other options can be configured
Auto-generate Signal reports or Signal Management Review reports, format using Word templates. Template based document creation but also with “Snippets that allow controlled introduction of non-core template text
Link to Risks, promote a confirmed signal to a risk/safety concern or configure a routine detection activity from a risk management activity
Link to Requirements Intelligence to ensure that signal notifications are handled timely
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

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 Requirements 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

Term Collections

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

DSUR Line Listing (blinded / unblinded)
DSUR Summary Tabulation (period/cumulative)
PBRER Summary Tabulation
SAE Line listing
PADER including device malfunctions
Reconciliation listing
PRR signal report (also available from Signal management)

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
Link to Requirements Intelligence to ensure that reports are timely against regulations
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

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

Maintain overview of global requirements (“obligations”) towards partners and authorities. The following requirement types are supported: Regulations / guidance, ICSR reporting, PV system and system master file, Periodic SUSAR reporting, Data Monitoring Committee, Medical Device reporting, Local QPPV / Safety Responsible, Risk Management Plan / Documents, Renewal Documents, Periodic Safety Update Report, Developments Safety Update Report, Signal Detection / Management
Allow for workflow-based management e.g. have local personnel to do the updates of a country’s rules. Setup approvals in the workflow e.g. from HQ
Requirements configured can auto-schedule to other modules of HALOPV e.g. Aggregate reporting or Submissions for generation and tracking of activities — or auto-generate reporting rules in Argus Safety via integration
Maintains an audit trail for all changes and updates
Is GxP validated* and ready to use in the cloud

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

Medical Information & Communication Module

Manage communication with patients, authorities and other relevant stakeholders (entities)
Retrieve information directly from emails and construct emails and send directly from the module
Use templates for building response documents
Ensure messages and approvals are tracked, including timelines for newly committed deliverables
Include electronic signature for digital workflows, as appropriate
Maintain a GxP archive of all interactions
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

*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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