Relevant bibliographies by topics / Risk Management in Clinical Research Digital Pharmacovigilance Solutions

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Academic literature on the topic 'Risk Management in Clinical Research Digital Pharmacovigilance Solutions'

Author: Grafiati
Published: 7 June 2025
Last updated: 2 August 2025

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Journal articles on the topic "Risk Management in Clinical Research Digital Pharmacovigilance Solutions"

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Vani, Pathuri. "Enhancing Pharmacovigilance in Clinical Trials." European Journal of Advances in Engineering and Technology 10, no. 7 (2023): 88–93. https://doi.org/10.5281/zenodo.15044250.

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Pharmacovigilance plays a critical role in ensuring drug safety throughout clinical trials, yet numerous challenges hinder its effectiveness. Issues such as data integrity, adverse event reporting inconsistencies, and safety monitoring in special populations create gaps in risk assessment. Additionally, global multi-center trials face regulatory discrepancies that complicate pharmacovigilance implementation. Advancements in digital and AI-driven solutions offer new opportunities to enhance real-time monitoring and risk management. This paper will examine the key challenges in pharmacovigilance
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Hussain, Mohd Shakir, Ajit Kumar Mishra, and Rishabh Pandey. "Pharmacovigilance: Enhancing Medication Safety Through Risk Management and Innovation." International Journal of Medical Science And Diagnosis Research 9, no. 3 (2025): 37–45. https://doi.org/10.32553/ijmsdr.v9i3.1054.

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Pharmacovigilance is a crucial component of healthcare systems, aimed at identifying, assessing, and preventing adverse drug reactions (ADRs) to ensure medication safety and effectiveness. This paper presents a comprehensive overview of pharmacovigilance principles, challenges, and future directions. The escalating volume of ADR data necessitates a robust global network of pharmacovigilance centres overseen by the Uppsala Monitoring Centre to uncover previously unnoticed ADRs. Despite notable advancements, underreporting of ADRs remains a challenge, particularly in developing nations, emphasiz
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Choudhari, Mr Narendra Kaluram. "A Review: Pharmacovigilance and Studies of Clinical Research for Health Care." International Journal for Research in Applied Science and Engineering Technology 13, no. 4 (2025): 4545–52. https://doi.org/10.22214/ijraset.2025.69294.

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Pharmacovigilance (PV) plays a critical role in ensuring drug safety by monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) and other medication-related risks. This review explores the evolution of pharmacovigilance, from its historical foundations to modern advancements in artificial intelligence, big data analytics, and real-world evidence (RWE). Key topics include global regulatory frameworks (e.g., WHO, ICH, FDA, EMA), methodologies for signal detection, risk management plans (RMPs), and the growing importance of patient-reported outcomes. Challenges such as unde
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Tinatin Gogrichiani. "Organization of the data monitoring process within the framework of clinical trials." International Journal of Science and Research Archive 14, no. 1 (2025): 1642–48. https://doi.org/10.30574/ijsra.2025.14.1.2627.

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This article explores innovative methodologies for organizing the data monitoring process in clinical trials, with a focus on traditional, remote, and risk-based approaches, as well as the integration of digital technologies. Through a comparative analysis of monitoring models, the study highlights the advantages of combining these methods in multicenter projects to enhance data accuracy, security, and compliance with modern regulatory standards. The findings demonstrate that digitalization and centralized systems significantly improve monitoring efficiency and risk management, offering action
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Bowles, Charlotte, Matthew Prettyjohns, Nathan Bromham, Alice Evans, Jenni Washington, and Rebecca Shepherd. "PD115 Digital Health Solutions: Health Technology Assessment Of Digital Platforms For Personalized Management, Education, And Support For People With Diabetes." International Journal of Technology Assessment in Health Care 40, S1 (2024): S138. https://doi.org/10.1017/s0266462324003556.

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IntroductionApproximately five million people live with diabetes in the UK. The cost of this is approximately 10 percent of the National Health Service (NHS) budget. Wales has the highest prevalence of diabetes of any country in the UK. Educating people on how to best manage their condition can minimize associated complications. Digital platforms can aid self-management and improve risk factors.MethodsThis rapid review aimed to address the following research question: What is the clinical and cost effectiveness of digital platforms for personalized diabetes management to inform decision-making
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Laiba Asif, Muhammad Danyal Khan, Maheen Rafique, et al. "Leveraging Artificial Intelligence in Pharmacy and Clinical Pharmacy Transformative Innovations for Precision, Operational Efficiency, and Enhanced Patient-Centered Care." Indus Journal of Bioscience Research 3, no. 5 (2025): 1–12. https://doi.org/10.70749/ijbr.v3i5.1225.

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By improving accuracy, operational effectiveness, and patient-centered care, the use of artificial intelligence (AI) in clinical pharmacy and pharmacy is transforming healthcare. Drug discovery, customized medicine, and pharmaceutical treatment management are being optimized by AI-driven advances, including machine learning algorithms, natural language processing, and predictive analytics. AI-powered decision support systems in clinical pharmacies increase workflow efficiency, decrease adverse medication reactions, and improve prescription accuracy. Real-time patient monitoring, AI-assisted dr
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Almalki, Manal. "Assessing the features of mobile Apps for self-management of postpartum depression." African Journal of Reproductive Health 29, no. 3 (2025): 132–42. https://doi.org/10.29063/ajrh2025/v29i3.16.

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Postpartum depression (PPD) is a significant global health concern, impacting the well-being of mothers and their infants during the postpartum period. Digital health solutions, particularly mobile applications, have emerged as promising tools for PPD management. This study systematically evaluates the landscape of PPD apps, identifying 115 relevant applications available on iOS and Android platforms. Through a comprehensive analysis, we assess their availability, popularity, key features, and technological advancements. Many of these apps integrate artificial intelligence (AI), machine learni
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Juma, Aisha, and Suleiman Nazik. "Risk Management and Patient Safety; The National Safety and Quality Health Service (NSQHS) Standards." Global Journal of Health Sciences 10, no. 1 (2025): 72–82. https://doi.org/10.47604/gjhs.3209.

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Purpose: The research aims at modifying two Standards of the National Safety and Quality Health Service (NSQHS) framework for UAE healthcare institutions which include both Clinical Governance and Medication Safety standards. This adaptation process is crucial for linking these standards to UAE regulations and healthcare infrastructure because of substantial cultural as well as legal technological and organizational differences between Australia and the UAE. Healthcare facilities in UAE will receive upgraded patient safety and quality of care through standards adaptations which reflect their s
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Daly, Robert Michael, Kevin Nicholas, Jessica Flynn, et al. "Association between remote monitoring and acute care visits in high-risk patients initiating intravenous antineoplastic therapy." Journal of Clinical Oncology 40, no. 16_suppl (2022): 1578. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.1578.

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1578 Background: Acute care visits (emergency department [ED] visits or inpatient admissions) for patients with cancer are growing disproportionately. Traditional oncology care models have not effectively identified and managed at-risk patients to prevent acute care. A next step is to harness advances in technology and mobile applications to enable patients to report symptoms any time, enabling “digital hovering” - intensive monitoring and management of high-risk patients. Our objective was to evaluate a digital platform that identifies and remotely monitors high-risk patients initiating intra
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Vandenberk, Thijs, Valerie Storms, Dorien Lanssens, et al. "A Vendor-Independent Mobile Health Monitoring Platform for Digital Health Studies: Development and Usability Study." JMIR mHealth and uHealth 7, no. 10 (2019): e12586. http://dx.doi.org/10.2196/12586.

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Background Medical smartphone apps and mobile health devices are rapidly entering mainstream use because of the rising number of smartphone users. Consequently, a large amount of consumer-generated data is being collected. Technological advances in innovative sensory systems have enabled data connectivity and aggregation to become cornerstones in developing workable solutions for remote monitoring systems in clinical practice. However, few systems are currently available to handle such data, especially for clinical use. Objective The aim of this study was to develop and implement the digital h
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Conference papers on the topic "Risk Management in Clinical Research Digital Pharmacovigilance Solutions"

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Fasanotto, Chiara, Annalisa Corradi, Rossella Onofrio, and Paolo Trucco. "Socio-Technical Risk Analysis for the Digitalized Transfusion Process: the e-TRAST Tool." In 16th International Conference on Applied Human Factors and Ergonomics (AHFE 2025). AHFE International, 2025. https://doi.org/10.54941/ahfe1006197.

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The digital transformation of the healthcare sector, while innovative for diagnoses and treatments, presents new challenges related to patient safety and the need to maintain a patient-centered approach. Among complex healthcare contexts, the transfusion sector, inherently both safety-critical and mission-critical, is increasingly characterized by the integration of digital solutions. These technologies, which play a crucial role in managing clinical data and supporting medical decision-making, are essential for ensuring the safety and efficiency of the transfusion process. However, the adopti
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