Available modules

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Local intake, case review screens, progress tracking / workflow compliance

Reconciliation with affiliates and partners

Follow-up management

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Manage multiple PSMF versions with separate contributors

Workflow for each annex

Auto-generate annexes, format using Word templates

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Submission compliance tracking, and handle timeliness of local (manual) submissions incl. lateness reasons

Analytics across manual and automated submissions

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Manage all local requirements and obligations for Authorities as well as partners and affiliates, across ICSRs, PSURs, SUSAR reporting etc.

Auto-build “reporting rules” and auto-schedule activities according to them

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Manage schedules and workflow progress of reports

Auto-generate report documents, format using Word templates

Supports a wide range of regulatory formats

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Global risk register

Manage risk strategy, Benefit-Risk evaluations, risk management documents, risk minimization measures (also locally) and other activities – global as well as local

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Manage agreements with partners, affiliates. Setup Authorities, Investigators, Committees etc. for use in other modules e.g. Submissions

Auto-generate SDEAs, format using Word templates and standard clauses

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GVP Module IX compliant tracking of signal management work

Track periodic and ad hoc detection activities and trigger signal detection activities via built-in EVDAS-like report or via integrations to 3rd party tools

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Easy registration of Market Research, Patient Support, Registries, social media etc.

Manage partner roles and spawn reconciliation activities

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QMS

Manage audit plans/reports

Track CAPAs globally and visualize effectiveness

Maintain QMS documents and deviations/NCs

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Clinical Studies

Manage studies and make them available for the other modules to deliver study-centric

Auto-generate Investigator / Ethics Committee reporting for Submissions

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Literature

Track local literature screening compliance

Manage sources

Setup queries and integrate with literature databases, e.g. Pubmed

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Products

Manage product information across families/groups, products and market/clinical licenses

Include active ingredients, NDA information etc.

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Interactions

Manage communication with Authorities and other relevant entities

Ensure approvals and track exact timelines etc. of responses

Maintain a GxP archive of all interactions

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Complaints

Intake and process customer complaints via case screens

Trigger investigations at various entities and track progress + spawn ICSRs

Manage customer feedback/follow-up process

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Labelling (coming May 2021)

Manage labels for products in local markets

Track label updates in local markets and initiate activities, e.g. from risks

Maintain MedDRA CMQ/PT registry for auto-listedness ICSR option

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