Sorcero Safety

Sorcero Safety is an advanced pharmacovigilance and literature monitoring platform developed in partnership with SpringerNature, purpose-built for biopharma and medical device companies. It revolutionises safety signal detection and adverse event reporting by unifying every critical data source into a single, auditable environment — enabling teams to detect Individual Case Safety Reports (ICSRs) from literature in minutes rather than months.

Designed for safety, regulatory, and medical affairs teams who cannot afford delays or missed signals, Sorcero Safety combines medically tuned AI with GxP-validated infrastructure to deliver real-time patient safety intelligence with uncompromising accuracy and full regulatory compliance.

Core Capabilities

• Unified data environment: Brings together internal and external data sources into one trusted platform, eliminating silos and providing a complete, single view of every safety topic.
• Instant signal detection: AI flags safety signals in real-time, enabling teams to act in minutes while others wait months.
• Industry-leading accuracy: Detects literature likely to trigger an ICSR with 96%+ accuracy and a 96%+ Negative Predictive Value (NPV) using advanced classifiers and large language models (LLMs).
• Dramatic efficiency gains: Reduces manual literature processing time by 89%, performing the work of hundreds of reviewers instantly.

Global Surveillance Coverage

• Global and local literature: Continuously ingests data from 50+ global and local sources, including Springer Nature literature.
• Internal structured data: Integrates with safety databases such as Argus, ArisG, and Veeva Safety, as well as clinical reports, lab results, and patient registries.
• Public regulatory sources: Monitors government websites, public databases including ClinicalTrials.gov, and medical device registries.
• Real-world unstructured data: Captures insights from social media, patient forums, and provider sites to ensure no signal is missed.

Real-Time Processing and Smart Automation

• Safety signal flagging: Identifies new, critical signals in real-time to help teams meet regulatory deadlines set by bodies such as the FDA and EMA, with a secure compliance buffer.
• Smart data tagging: Automatically analyses and categorises information against ICSR and safety criteria using advanced classifiers and LLMs.
• Accelerated adverse event reporting: Auto-tags content likely to trigger ICSRs, surfaces supporting literature, and speeds up regulatory submissions.
• Enhanced patient safety: Detects emerging safety issues immediately, enabling real-time risk mitigation and timely updates to patient and prescriber safety information.
• Strategic agility: Transforms raw signals into strategic intelligence to inform real-world evidence (RWE) and asset strategy decisions.

Scientific Validation and Responsible AI

• Medical credibility: Purpose-built and continuously tuned by domain experts; trusted by major biopharma and medical device companies for sensitive data analysis, with validation studies published alongside partners including UCB, Moderna, and AstraZeneca.
• Transparency: Provides clear visibility into every flagged signal through platform analytics and auto-summaries, ensuring actionable and auditable intelligence with no black boxes.
• Compliance first: Delivers complete traceability and audit trails for every decision, closing surveillance gaps and meeting requirements for ICSRs and Medical Device Reports (MDRs).

Sorcero Safety is fully compliant with GxP, GVP, 21 CFR Part 11, and GDPR standards. The platform is GxP-validated and provides end-to-end audit trails, making it suitable for regulated pharmacovigilance workflows across global biopharma and medical device organisations.