Enhanced Safety Reporting and Compliance for a Global Consumer Health Company
The consumer health industry, with its stringent regulatory landscape, demands precision and transparency in adverse event reporting to ensure consumer safety and maintain regulatory compliance. When this global consumer health company transitioned to operate independently, it faced the challenge of building a seamless, scalable safety data infrastructure. Enstructure assembled a team, including advisory, architect, business analysts, program managers, and data engineer to build a solution to help the company streamline its safety reporting systems, enabling timely regulatory compliance and fostering trust and transparency with end consumers.
This leading global consumer health company, emerging from a larger corporation, is responsible for a wide range of health-focused consumer products. As it established itself as a standalone entity, the company prioritized operational excellence in areas like safety reporting and analytics—essential for regulatory compliance and consumer trust. Partnering with Enstructure, the organization sought to enhance its safety data processes, specifically in adverse reaction case management, reporting, and analytics, to ensure timely and accurate regulatory compliance.
THE PROBLEM
The company encountered several critical challenges in managing and streamlining its safety reporting processes:
- Regulatory Requirements and Compliance: The organization needed to navigate complex regulatory requirements across multiple regions to align its safety reporting processes with global standards. Adverse event reports had to be precise and timely, adhering to specific submission timelines and reporting formats. Delays or inaccuracies could lead to compliance risks, impacting consumer trust and safety. The organization’s reporting requirements included the following critical components:
- Identification Information: Details about the reporter and patient.
- Event Description: Clear descriptions of adverse events, including onset, duration, and severity, along with product details.
- Causality Assessment: Evaluation of the likelihood that the product caused the adverse event.
- Outcome of the Event: Information on the outcome of the adverse event (e.g., recovery, ongoing symptoms, hospitalization, or death).
- Timing of the Event: Documentation of when the event occurred in relation to product administration.
- Previous Exposure: Information about any prior exposure to the product or similar products.
- Follow-up Information: Additional updates about the patient’s condition or adverse event outcome.
- Signal Detection and Risk Management: Reporting requirements may also include how the adverse event fits into broader safety surveillance and risk management activities.
- System Integration and Data Management: Data from over 15 interconnected systems needed to be efficiently integrated into a single data hub to support accurate reporting. This hub had to ensure daily data availability without interruptions, as any delay could impact the analytics team’s ability to process data and generate timely reports.
- Stakeholder Trust and Transparency: The company’s mission to deliver safe, consumer-centered products relied on transparent reporting and continuous improvement. Ensuring seamless data flow from adverse reaction intake to safety reporting would not only improve internal processes but also reinforce trust with healthcare providers and end consumers.
- Vendor Software Upgrade: A key challenge was managing the upgrade of a critical vendor’s software, which required careful coordination to prevent delays and ensure that it integrated seamlessly into the new reporting framework.
- Cybersecurity Negotiations: The project required negotiating cybersecurity requirements across multiple stakeholders and organizations, ensuring that data security standards were met while maintaining compliance with regulatory obligations.
- Vendor Divestiture: A significant complication arose with the divestiture of a key vendor, which added complexity to the integration and continuity of essential services during the transition.
SOLUTIONS PROVIDED
Enstructure designed and implemented a customized solution to address the company’s specific regulatory and operational needs. The approach involved three phases:
Phase 1: Discovery
- Conducted an in-depth review of the company’s regulatory reporting requirements to design a compliant safety reporting workflow.
- Identified and documented data intake, processing, and reporting.
Phase 2: Implementation
- Centralized Data Hub: Developed a centralized hub consolidating data from multiple systems for adverse reaction processing and analytics.
- System Uptime Monitoring: Designed monitoring mechanisms to ensure the reliability of critical systems as the project approached deadlines.
- Automated Adverse Event Management System: Implemented an automated workflow for adverse reaction case processing, ensuring accurate and timely reporting.
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Three Main Functions:
- Adverse Event Case Intake Systems: These systems capture cases from Salesforce and other pharmaceutical systems, ensuring comprehensive data collection from various sources.
- Adverse Reaction Case Processing: This function processes the cases for reporting to health authorities and feeds the relevant data into the Data Hub, maintaining compliance with regulatory requirements
- Adverse Reaction Reporting and Analytical Systems: This includes the Data Hub and various consumers of the data for analytics, facilitating efficient reporting and in-depth analysis of adverse events.
Phase 3: Monitoring and Support
- Conducted ongoing compliance reviews and performance metrics tracking.
- Provided training and documentation for internal teams to manage the safety reporting systems independently.
THE OUTCOME
Our collaboration with this global consumer health company led to significant improvements in regulatory compliance, operational efficiency, and stakeholder trust. These are the key benefits achieved through our partnership:
Regulatory Compliance Assurance
The company now consistently meets all regulatory requirements across multiple regions, achieving 100% compliance in adverse event reporting. The standardized Data Hub minimizes manual errors, ensuring timely report submissions and maintaining an overall 100% Data Ingestion Success Rate.
Operational Efficiency
Automated processes reduced the time required for safety reporting, freeing up resources for other critical business functions.
Enhanced Trust and Transparency
The organization strengthened consumer trust and its reputation by prioritizing safety and transparent reporting.
This project is a testament to Enstructure’s ability to not only deliver cloud infrastructure but also to serve as a strategic advisor. By bridging communication gaps between internal teams and third-party vendors, Enstructure ensured seamless integration and the successful delivery of critical infrastructure components.
The role went beyond just technical execution; Enstructure’s expertise in aligning security, compliance, and operational processes was vital to the project’s success, demonstrating Enstructure’s capacity to drive both tactical and strategic outcomes.
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