eSAE Clinical Trial Safety Information Management

eSAE is a Clinical Trial Safety Information Management System developed by Taimei Technology, designed to support compliant and efficient collection, processing, and reporting of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). The platform is built for Clinical Research Coordinators (CRCs), Project Managers (PMs), Clinical Research Associates (CRAs), and pharmacovigilance (PV) teams who need to manage the full lifecycle of safety information with real-time analysis and automatic archiving.

eSAE addresses four core operational priorities: managing SAE task progression, controlling risks related to timeliness, compliance, and completeness, enhancing efficiency across reporting and distribution workflows, and reducing the overall costs associated with SAE distribution.

AI-Enhanced SAE Reporting and Online PV Management

• One-click follow-up report creation with over 80% accuracy, significantly reducing manual effort.
• Reuse of over 40 fields across reports without re-entry, improving both speed and accuracy.
• Laboratory monitoring forms are auto-imported using intelligent recognition, eliminating the need for manual data input.
• OCR technology automatically scans and imports paper records, removing manual entry requirements.
• Automatic duplication detection and discrepancy checks improve overall efficiency and reduce reporting errors.
• Reports are received online and automatically generate corresponding SAE processing tasks for immediate action.

Automated Archiving of Safety-Related Documents

• Automatically captures documents across the entire SAE lifecycle, including collection, processing, submission, and distribution stages.
• Automatically generates corresponding folders and directory structures to maintain organised records.
• Integrated with Taimei Technology's eTMF (eArchives) system, eliminating the need for manual archiving and ensuring seamless document management.

Visualised SAE Tracking for Efficient Risk Management

• Provides visual dashboards displaying task progress, safety trends, and key business metrics to help PMs and CRAs track SAE progress and associated risks.
• Supports informed decision-making through real-time data presentation.
• Countdown reminders ensure timely report processing and submission, reducing the risk of missed regulatory deadlines.
• Keeps teams updated with industry trends and regulatory interpretations to maintain ongoing compliance.

Extensive Project Experience and Client Support

• Has served over 500 domestic and international clients across clinical trial programmes.
• Offers comprehensive after-sales service with quick response capabilities to accommodate regulatory changes.

eSAE integrates with other Taimei Technology solutions including eCooperate (CTMS), eArchives (eTMF), and eCollect (EDC), enabling a connected clinical trial management ecosystem. The platform is suited for organisations seeking to standardise and automate safety information workflows while maintaining regulatory compliance across global clinical operations.