Objectives

The primary objective of this tender is to procure a comprehensive Pharmacovigilance Digitization Solution that includes maintenance and support for a period of 36 months, with an option to renew for an additional 24 months. The solution aims to modernize SAHPRA’s core business processes related to pharmacovigilance activities, enhance operational efficiency, ensure regulatory compliance, and support the organization’s broader digital transformation strategy. A key focus is on implementing a highly customizable, integrated system that facilitates adverse event reporting, case management, signal detection, aggregate reporting, and regulatory compliance across various jurisdictions and product categories.

Scope

The scope encompasses the provision of a fully integrated pharmacovigilance platform as part of the Regulatory Information Management Ecosystem (RIMeS). It includes:

• Development and deployment of a digital system supporting end-to-end adverse event and product complaint management.
• Integration with third-party software tools such as document management systems, coding dictionaries (MedDRA, WHO Drug Dictionary, VEDDRA, IMDRF/UDI), and external data sources.
• Implementation of functionalities for data collection, case triage, assessment, validation, follow-up, and automated duplicate detection.
• Advanced signal detection using biostatistical methods and AI-powered trend analysis.
• Generation of aggregate reports, dashboards, and regulatory compliance documentation.
• Support for regional decentralization and interoperability with external systems (e.g., VigiFlow, NDOH, AMA, UMC).
• Provision of a scalable, secure, and user-friendly platform supporting multi-language and mobile/web access.
• Maintenance and support services for 36 months, with options for renewal.

Technical Requirements

The technical specifications include:

• Compliance with international standards such as ICH E2B(R3), IMDRF UDI, and other relevant regulatory frameworks.
• Robust data collection, validation, and case management functionalities supporting structured data entry, follow-up, and traceability.
• AI and ML capabilities for automated case coding, narrative generation, causality assessment, and trend detection.
• Advanced signal detection techniques including ROR, PRR, EBGM, Bayesian models, and data mining algorithms.
• Interactive dashboards with real-time visualization, customizable reports, and automated alerts.
• Interoperability via REST/SOAP APIs, XML data exchange, and integration with external systems such as VigiFlow, NDOH, and WHO databases.
• Security features including role-based access control, audit trails, compliance with GDPR, HIPAA, GxP, CFR 21 Part 11, and EU Annex 11.
• Cloud hosting in SAHPRA’s environment, ensuring data privacy and compliance with POPIA.
• User-friendly interface with multi-language support, notifications, electronic signatures, and training resources.

Skills Requirements

The successful bidder must demonstrate expertise and experience in the following areas:

• Pharmacovigilance and Regulatory Affairs: Proven knowledge of pharmacovigilance processes, international standards, and regulatory requirements.
• Software Development & Implementation: Experience in deploying enterprise-level PV systems, including customization, integration, and support.
• AI & Data Science: Capabilities in AI/ML for case coding, narrative generation, trend analysis, and signal detection.
• System Integration: Ability to integrate with external databases, APIs, and regulatory systems (e.g., VigiFlow, NDOH, AMA).
• Project Management & Support: Skilled in managing large-scale IT projects, providing ongoing support, training, and system maintenance.
• Security & Compliance: Expertise in implementing secure systems compliant with GDPR, HIPAA, GxP, CFR 21 Part 11, and other relevant standards.
• User Experience & Training: Capable of designing intuitive interfaces and providing comprehensive user training and documentation.