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Scirj Volume XII, Issue XI, November 2024 Edition
ISSN: 2201-2796

Pharmacovigilance Challenges: Ensuring safety data integrity and ADR reporting by Investigators in randomized multi-center clinical trials

Tinatin Gogrichiani

Abstract: This study addresses the critical challenges in ensuring data integrity and adverse drug reaction (ADR) reporting within randomized multi-center clinical trials, focusing on the transformation of pharmacovigilance through digital technologies. The research methodology combines analysis of spontaneous reporting systems, electronic medical records (EMR), and mobile applications to evaluate their effectiveness in ADR monitoring. The findings reveal a tenfold increase in ADR reporting through mobile applications and significant improvements in data quality through EMR integration. The study demonstrates that standardization using ICD and ATC coding systems, combined with artificial intelligence methods, substantially enhances the detection of drug safety signals, with over 1,000 previously unknown drug-reaction associations identified. This research contributes to the field by establishing a comprehensive framework for integrating digital solutions in pharmacovigilance, providing evidence-based recommendations for improving ADR reporting in multi-center clinical trials, and highlighting the synergistic effects of combining different monitoring approaches for enhanced patient safety.

Reference this Paper: Pharmacovigilance Challenges: Ensuring safety data integrity and ADR reporting by Investigators in randomized multi-center clinical trials by Tinatin Gogrichiani published at: "Scientific Research Journal (Scirj), Volume XII, Issue XI, November 2024 Edition, Page 11-15 ".

Search Terms: pharmacovigilance, adverse drug reactions, clinical trials, data integrity, electronic medical records, mobile applications, artificial intelligence, standardization, patient safety, drug monitoring

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