Pharmaceutical companies that produce and distribute drugs worldwide need to define, document and publish a business process for the reporting and tracking of side-effects that might occur due to the drug usage. These side-effects are referred to as Adverse Events. Every pharmaceutical company must record and categorize these Adverse Events. Once categorized, these events need to be reported back to the FDA and other regulatory agencies like the EMEA and local country agencies. These regulatory agencies define the timeframe (based on the severity of the report) in which the events need to be reported to them (from the time of diagnosis to the filing with the agency). Delays in reporting these adverse events can lead to the company being fined heavily or even having to pull the drug from the market.

Due to the strict FDA guidelines on Adverse Event reporting, pharmaceutical companies are required to streamline and automate their Adverse Event Management System. Several companies have existing systems which do not cover the end-to-end processes. This makes the process inefficient and requires constant audits to ensure quality and completeness.

Some of the key challenges that pharma companies face are:

Business Challenges

• due to multiple acquisitions and mergers in the pharma space, the business has to deal with disparate systems (ARISg, ARGUS, home grown systems etc.)
• no central location for all adverse event reports
• no unified interface for receiving adverse event reports from partners, regulators, local sites, call centers etc.
• non-compliance with EMEA regulations to accept in-bound E2B reports
• need to segregate AE reports from non-AE reports
• no framework to track, report productivity of teams
• reporting needs to provide information to regulators (FDA/EMEA), local regulators (country offices), qualitative analysis of data, legal teams etc.

Process Challenges

• migrating from a paper based business process to an automated process
• integration with existing systems
• need to adapt frequent changes in the business processes
• consistent way to handle the gathering, storage, processing and retrieval of adverse events
• compliance with FDA regulations (21 CFR Part 11)
• compliance with enterprise security guidelines
• process, store and distribute adverse event data in the industry specified standard (e2b XML)
• data warehousing and reporting

We can provide you with a comprehensive Adverse event Management solution customized to your needs.

Key Benefits of this solution are:

Business Benefits

Reporting

The solution provides business users with the ability to run the following reports:

• legal requirement reports (class actions)
• partner reports
• local/partner follow-up reports
• local office regulatory reports (country offices)
• corrective action planning reports
• processing productivity reports

Compliance

• validated system compliant with FDA regulations (21 CFR Part 11)
• well defined business process to handle the triaging and reporting of Adverse Event data to the FDA, EMEA and local regulatory agencies
• compliant with EMEA regulations to accept in-bound E2B Adverse Event data from European regulators

Central Source of Adverse Event Reports

• the system was the primary image repository of all adverse event reports
• ability to triage and categorize adverse event data

Integration of data across systems

• the system provided the business with a means to integrate with disparate systems as well as legacy systems

Technical Benefits

• workflow based system
• adapter based architecture to integrate with external (third party) systems
• clustered environment to achieve high availability (failover)
• clustered environment to handle load requirements (load balancing)
• customizable components to handle change in business processes
• separation of business logic from workflow engine (high maintainability and reusability)
• definition of standard interfaces to accept and distribute adverse event data
• extensive use of XML to adapt to change in FDA regulations (flexibility)
• validated system compliant with FDA regulations (21 CFR Part 11)