Download Ultragenic Brochure

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.

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

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.

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:

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:

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.