Preeti Gupta and Himanshu Tandon

• 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.

• Automated ICSR Submissions to Health Authority and License Partners.

• Dedicated Managed Service team will perform Gateway Registration, Testing hence no functional burden on MAH/CROs.

• Curtailed solutions for MAH and CROs.
• Customers can add multiple License Partner and Health Authorities.

• 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.

• Intuitive Chat based UI
• Quick data insights
• Fine-tuned for PV on Large Language Models (LLMs)
• Continuous updates

• Visual Analytics
• Drill Through Functionality
• Dynamic Dashboards
• Mobile Support

• Simple Line Listing & Summary Tabulations
• Cross Tab Reports
• Multiple Charts (Bar, Line, Donut etc.)
• Ad hoc Reporting
• Multiple Format Export, Easy Drag & Drop

• Multi-tab Excel Reports
• High Precision Reports
• Print Ready Reports
• Report Scheduling
• Report Bursting

• 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

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
• Difficult Reconciliation – Manual reconciliation lowers productivity
• 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

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.

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

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.