Crowne Plaza Geneva, Switzerland | 14 - 15 May 2025 | Booth #21
Increasing volume and complexity of case reports raise the stakes for missed critical information and non-compliance consequences.
The life sciences industry is witnessing multiple challenges in the safety domain due to the rapidly increasing volumes of data generated from multiple sources. Existing PV systems are not equipped to handle the increased quantum of data in a timely and accurate manner. In addition, increased regulatory compliance and submission standards by the regulatory bodies have led to higher quality and safety requirements, resulting in increased non-compliance risks and higher costs.
TCS ADD™ Safety uses human-governed machine learning (ML) to enable AI modeling algorithms, traceability, transparency and learning management capabilities in accordance with Good Pharmacovigilance Practices (GVP) through our strategic investments in PV automation.
Template less full automation of intake and data entry
Modular deployment with an interface to safety database
Transparent AI with human governed learning management
E2B and non-E2B field output generation with compliance auto check to reduce manual intervention
Performance management module with customized dashboards and reports
Facilitates automated safety data collection directly from any source with a template-less technology.
Provides automated validity and duplicate checks, data entry, medical coding, case assessment including seriousness, causality and listed ness. The solution also helps with automated narratives and report generation.
Offers a set of performance metrics reports with deep actionable insights, improving operational governance.
Enhances efficiency and compliance of the E2B output generated with predictive analytics and optimizes the time and effort of the PV team.
With the TCS ADD™ platforms, life sciences companies across the world can harness the power of AI and analytics to accelerate the development of new, more effective drugs for patients. TCS ADD™ Safety helps transform safety case processing and meet business and regulatory requirements effectively and efficiently.
