Modules Overview
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Manage products based on families, products and market licenses. Capture information such as substances, NDA codes, IBD etc.
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Map products according to IDMP structures, i.e. setup Medicinal Product, Pharmaceutical Product, Device, Ingredients, Substances etc.
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Create Product index and associated synonyms to allow for coding and linking reported names to actual products
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Option to use as a standalone tool, or can also be integrated to e.g. RIMS (Regulatory Information Management System) or safety database
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Links to all other modules, in order to provide product information
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Link to PSMF module, to populate Annex H
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Products Module
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Setup a register of clinical studies and manage status
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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
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Integration with external Safety database – Information is automatically transferred to HALOPV
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Option of integrating with existing CTMS (Clinical Trial Management System) or run as independent system
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Option to include other distributions for investigators such as training, contracts, etc.
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Link to PSMF module, to populate Annex C/H or Study list
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Clinical Studies Module
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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
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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
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Link to PSMF module, to populate Annex A, B and C
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Entities Module
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Intake and process customer complaints via case screens
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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
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Maintain and assign own problem codes and/or utilize IMDRF codes
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Integrate with external QA / call center systems via API
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Link to QMS module / or externally via API, to initiate new deviation / CAPA
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Manage feedback loop with customers and conduct follow-up queries
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Complaints Module
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Intake device information in structured MIR forms or unstructured text from affiliates, partners/contractors – or even directly from consumers
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Manage device case processing in HALOPV, including site/manufacturers evaluations, ÍMDRF coding etc.
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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).
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Reconcile device reports from local, clinical etc. sources with HALOPV
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Device Reporting Module
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Maintain information on literature monitoring and review, including listing of publication sources that are being monitored.
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Schedule monitoring activities at central and local level, and track timeliness.
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Automatically collect articles via Integration of literature sources, e.g. PubMed
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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
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Out-of-the-box integration with HALOPV ICSR handling or other safety databases, e.g. Argus and ARISg via E2b(R3)
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Literature Module
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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.
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Manage signal detection schedules and create Signal Detection Plans
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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
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Ability to pull in multiple datasets, including "internal data" from Safety Database (see ICSRs module), OpenFDA, EVDAS - other options can be setup.
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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
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Link to Risks, promote a confirmed signal to a risk/safety concern or setup a routine detection activity from a risk management activity
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Link to Requirements Intelligence to ensure that signal notifications are handled timely
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Signals Module
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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
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Built around a powerful workflow engine that allows for the creation, review and approval of risk management documents
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Utilize MedDRA queries collections that are standardized across modules, to ensure that terms and medical concepts are assigned, reviewed and maintained against the risk
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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
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Monitor timeliness across all deliverables using built-in charts, including a Gantt overview of risk commitment activities
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Links with Signal modules for fully integrated signal & risk process
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Use in collaboration with Requirements Intelligence to ensure that risk management activities are in alignment with global regulatory requirements
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Risks Module
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Manage the Summary of Product Characteristics (SmPC), store and update the documents and create collections of terms in SmPC
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Create new CMQs or review SMQs
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Add lists of terms in collections forsignal detection, aggregate reporting etc. e.g. Keep under review terms
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For ICSRs, you can use the label collections with an automator to auto-assessment event listedness
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Dictionaries & Terms Module
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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 (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)
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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
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Monitor timeliness across all deliverables, and utilize built-in charts including Gantt overview of activities.
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Link to Requirements Intelligence to ensure that reports are timely against regulations
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Aggregate Reporting Module
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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
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Configurable to local guidelines - and maintain multiple different versions of the Annexes, e.g. for EEA, France, CIS, India in the same application
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Removes the need for emailing of documents for review to affiliates and other stakeholders
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Allows ease of document generation – as no manual data collation is required, focus of review is on content
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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
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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
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Automates data gathering of Annexes
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Auto-generate Annex I (logbook)
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Maintains an audit trail for all changes and updates
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Use various pdf functionalities for headers/footers and merging of final document
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
PSMF Module
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Maintain overview of global requirements (“obligations”) towards partners and authorities. 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
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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
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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
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Requirements Intelligence Module
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Manage data collection programs such as Patient Support Programs, Market Research Programs, Web sites etc. and distribute tasks locally or centrally
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Link data collection programs to partners and their agreements from the Entities module, to control access and monitor entity performance
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Schedule data collection program specific reconciliation activities, e.g. to ensure that ICSRs have been processed and reported
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Link to PSMF module, to populate Annex B and C
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Data Collection Programs Module
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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
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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
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Track audit deliverables and create tables and graphs of performance and e.g. findings per category
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Managing QMS documents, schedule and perform training by individuals
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Mange deviations / non-conformities and track timeliness
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Manage training records for staff, including timeliness tracking
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Quality Module
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Manage PV Agreements (SDEAs) with partners, affiliates etc.
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Auto-generate SDEA documents, format using Word templates
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Snippets control standard clauses that can be selected for inclusion into the agreement
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Electronic signature allows for fully digital workflows, also with non-HALOPV users
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Link to PSMF module, to populate Annex A, B and C
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Link to the Requirements Intelligence module, to setup partner obligations
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Agreements Module
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Submit ICSRs to Authorities and other stakeholders seamlessly and via either automatic or manual workflows, as per reporting destination capabilities
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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.
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Integrates with AS2 gateway, emails and “burn-links” for secure transmission
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Auto-detects late submissions and enforces a LTI form (Late Task Investigation) to ensure a compliant way of managing deviations
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Link to requirements, use requirements to schedule activities and reversely i.e. track the number of actual submissions sent out based on requirements
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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
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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.
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Submissions Module
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Manage communication with patients, authorities and other relevant stakeholders (entities)
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Retrieve information directly from emails and construct emails and send directly from the module
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Use templates for building response documents
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Ensure messages and approvals are tracked, including timelines for newly committed deliverables
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Include electronic signature for digital workflows, as appropriate
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Maintain a GxP archive of all interactions
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Maintains an audit trail for all changes and updates
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Is GxP validated* and ready to use in the cloud
*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 for your organization.
Medical Information & Communication Module
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Receive data from affiliates, partners, contractors, or even directly from costumers
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Integrate multiple email sources to easily receive information in one consolidated inbox
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Intake ICSR information in structured AE forms or unstructured text
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Leverage AI and automation to extract data from structured forms directly into database fields
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Compare original source document with data in HALO
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Use AI for translation to and from local language
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Easily integrates with your safety database for case reconciliation, enabling an accurate duplicate check early in the intake process
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Manage follow-up information requests quickly and easily directly from intake
*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 for your organization.
Case Intake Module
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Data Mart provides access to data from all other modules
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Data are normalized and decoded for easy use
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Connect your own preferred Business Intelligence solutions and create reports, dashboards, etc.
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Provides additional capability to expand the already rich reporting features available in HALO
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Provides a landing area for integrations with other systems
*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 for your organization.