In July 2023, the US FDA initiated a 2-phase Pilot Test program involving six leading companies to finalize guidelines for submitting pre- and post-marketing Individual Case Safety Reports (ICSRs) in E2B R3 format. This program introduced 28 additional data elements...
Dedicated team will monitor, alert Authorization Holder or CROs in case of any system errors during submissions which will prompt submission teams/system teams to take necessary action and re-transmit the cases before actual due date expires.
Complete Automation
Automated ICSR Submissions to Health Authority and License Partners.
Registration and Testing Support
Dedicated Managed Service team will perform Gateway Registration, Testing hence no functional burden on MAH/CROs.
Flexible
Curtailed solutions for MAH and CROs.
Customers can add multiple License Partner and Health Authorities.
Safety Database Integration
Complete integration with Safety System for Inbound ICSR Receipt and Outbound ICSR submissions to Health Authorities and License Partners.
Automated Acknowledgement receipt and delivery between Safety System and Partner / Health Authority gateways.
Natural Language Querying
Intuitive Chat based UI
Quick data insights
Fine-tuned for PV on Large Language Models (LLMs)
Continuous updates
Visualizations & Dashboards
Visual Analytics
Drill Through Functionality
Dynamic Dashboards
Mobile Support
Self-service Reporting
Simple Line Listing & Summary Tabulations
Cross Tab Reports
Multiple Charts (Bar, Line, Donut etc.)
Ad hoc Reporting
Multiple Format Export, Easy Drag & Drop
Pixel Perfect Reports
Multi-tab Excel Reports
High Precision Reports
Print Ready Reports
Report Scheduling
Report Bursting
Snowflake Warehouse
Virtual Warehouses for Data pipeline and Querying
Micro-partitions and caching for quick data retrieval
Cost-effective since you pay for compute and storage you use
Time Travel for Historical Data Retrieval
Row Access Policy for Data Security
Mailbox Management
Challenges:
Overloaded Mailbox – Overstretching mailboxes with too many users, rules, folders etc. creates slowness & sync issues
Error Prone – Emails could be deleted/missed due to human error or folder movement issues
Tedious Triaging – Prioritization of emails are usually done outside the mailbox, resulting in manual organization effort and inefficiency
Lack of centralized tracking – No centralized tracking of cases from different sources (Pharmacies). Insights related to volume, trends, patterns not available
Compliance Issues (in control for now) – Missed or delayed cases result in regulatory non-compliance
Solutions Overview/Features:
A separate web interface is provided for efficient case triaging and management instead of using mailboxes
User-defined workflows with automations are supported to streamline the process and increase efficiency
Automated reconciliation from mailboxes to downstream systems ensures accuracy and reduces manual effort
The dashboard provides quick insights, trend analysis, and monitoring capabilities
Success/failure and reconciliation reports can be scheduled and distributed to respective stakeholders
An inbuilt email client allows for outbound communication directly from the system
Segregation of emails from different sources, such as shared mailboxes, helps prioritize incoming cases
Custom parameters can be used to tag cases for advanced filtering and quick searches.
Automatic identification of cases vs. non-cases reduces the need for manual sorting
Automatic assignments to groups and users based on configured conditions ensure prompt handling by appropriate personnel
The system meets all regulatory requirements and standards for improved compliance
Structured Form Processing
Challenges:
Variety of forms used by Affiliates and Partners for sending AE Reports
Increasing Volume of Structured Forms
Clinical forms generated from studies (EDC system)
Manual data entry is a time-consuming and error-prone process
Need of data review and quality check
Lack of automatic validations
Complicated steps to identify duplicate forms
Tedious and inefficient reconciliation process
Solutions Overview/Features:
Supports extraction of ICSRs from various formats, including standard and custom forms in Excel, Word, PDF, XML, and scanned images.
Offers pre-configured forms for frequently used types like CIOMS, MedWatch, and E2B R2/R3.
Uses indigenous and proprietary algorithms to ensure excellent accuracy.
Enables audit logging for all activities as per 21 CFR Part 11 compliance.
Provides configurable workflows for monitoring, including data validation and review.
Automatically identifies duplicate forms and provides assistance.
Can extract checkboxes, dynamic fields/sections, expanding sections, and multi-line table records to handle complex scenarios.
Seamlessly integrates with safety systems through E2B R2/R3, APIs, and Native UltraFormat.
Offers both automated and manual workflow configuration.
Allows for configurable data validations.
Reduces manual effort for data entry.
Regulatory Integration
Challenges:
Maintenance of search schedules and queries for different products
Variety of intake formats (XML, PDF, Excel, ASCII)
Extraction of individual case data from single bulk file
Manual downloads may lead to duplicate / missed cases
Inclusion of source documents with downloaded cases
Manual data entry
Tedious reconciliation process
Reports can’t be produced easily for regulatory audits
Solutions Overview/Features:
Seamless Integration with Regulatory Authority e.g., EV-Web, HA CANADA
High performance solution to handle huge case volume.
Ability to configure schedules and search criteria
Interface to filter/triage cases using Duplicate Search functionality
Complete automation from downloading cases till import in Safety System
Configurable workflow to add automated or Manual step as per company processes for review & approvals
Web Intake (Patient, HCP, Affiliates)
Challenges:
Need of different user interfaces based on type of users (Patient, Company Employee, HCP)
New forms require customizations
Modification into existing form has dependency on vendor
Need of multiple forms (PSP, Clinical, Post-marketing etc.)
Integration with dictionaries – Products, MedDRA
Difficult Reconciliation Process
Integration with multiple target systems
Solutions Overview/Features:
Automates the case intake process from Pharma Company’s public/private web portals.
Offers flexibility in data ingestion, supporting both E2B and Non-E2B data.
Provides a time and cost-efficient process for case intake.
Offers a reconciliation report mechanism for periodic insights into the case intake process.
Offers a fully configurable user-friendly interface.
Comes with built-in intelligence for setting validation rules.
Provides encryption in transit and at rest for security and compliance with regulatory requirements.
Allows for branding with images and color customization.
Integrates with MedDRA and Drug Dictionaries for event/product encoding.
Provides seamless integration with PV & Clinical Systems for safety systems.
Offers multi-lingual forms to interact with a diverse group of users.
Provides user access control for company employees and administrators.
