IMPLEMENTATION OF DIGITAL TECHNOLOGIES FOR QUALITY ASSURANCE IN CLINICAL RESEARCH PROJECTS EXECUTION: A COMPREHENSIVE REVIEW
Abstract
The article explores the peculiarities of digital transformation of clinical research industry along with implementation of specific digital tools that have influenced approaches to quality assurance in clinical trials. The relevance of the study lies in the rapid digital transformation of clinical trials, which creates new opportunities for improving data quality, ensuring participant safety, and enhancing compliance with regulatory requirements, while traditional monitoring approaches remain resource-intensive and limited in detecting systemic issues. The aim of the article is to provide a comprehensive analysis of the implementation of digital technologies in quality assurance of clinical trials and to systematize their impact on key processes. The research methodology is based on a systematic review and analytical synthesis of scientific publications released from 2004 through 2026, including comparative and structural analysis of modern digital tools used in clinical trials, as well as generalization of empirical findings related to their effectiveness. The results demonstrate that the transition from traditional monitoring to risk-based and data-driven approaches significantly improves the efficiency of quality assurance systems. The implementation of electronic data capture and electronic source data reduces transcription errors, accelerates data validation, and enables real-time monitoring. The use of centralized analytics, artificial intelligence, and machine learning allows for early detection of anomalies and more effective risk prioritization. In addition, mobile technologies, wearable devices, and decentralized trial models expand the scope of data collection and support continuous monitoring beyond research sites. Integration of these technologies creates cumulative benefits, enhancing operational efficiency and reducing the overall workload on research teams. The practical value of the study lies in identifying key advantages and limitations of digital technologies and substantiating their role in forming integrated, proactive quality assurance ecosystems, which can be applied to optimize clinical trial management, improve decision-making processes, and support the development of more flexible and scalable research designs.
References
Yamada O., Chiu S.W., Nakazawa T. et al. Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture. Trials. 2024. Vo. 25, P. 384. DOI: https://doi.org/10.1186/s13063-024-08242-2.
Mitchel J.T., Schloss Markowitz J.M., Yin H. et al. Lessons learned from a direct data entry phase 2 clinical trial under a US investigational new drug application. Therapeutic Innovation and Regulatory Science. 2012. Vol. 46, № 4, Pp. 464-471. DOI: https://doi.org/10.1177/0092861512449530.
Jiang M., Zhao S., Mei Y., Fu Z., Yuan Y., Ai J., Sheng Y., Gong Y., Chen J. Real-time, risk-based clinical trial quality management in China: development of a digital monitoring platform. Journal of Medical Internet Research – Medical Informatics. 2025. Vol. 13, Article e64114. DOI: https://doi.org/10.2196/64114.
Yamada O., Chiu S.-W., Takata M. et al. Clinical trial monitoring effectiveness: remote risk-based monitoring versus on-site monitoring with 100% source data verification. Clinical Trials. 2020. Vol. 18. №2. Рp. 158-167. DOI: https://doi.org/10.1177/1740774520971.
Rosenberg L., Levaux H., Levine R.L., Shah A., Denmark J., Hereema N., Owen M., Kalk S., Kenny N., Vinson G., Vergilio J. A., Mims A., Borate U., Blum W., Stein E., Gana T. J., Stefanos M., Yocum A., Marcus S., Shoben A., Druker B., Byrd J. Streamlined operational approaches and use of e-technologies in clinical trials: Beat acute myeloid leukemia master trial. Therapeutic Innovation and Regulatory Science. 2021. Vol. 55, №5. Pp. 926-935. DOI: https://doi.org/10.1007/s43441-021-00277-w.
Tantsyura V., Dunn I.M., Waters J. et al. Extended risk-based monitoring model, on-demand query-driven source data verification, and their economic impact on clinical trial operations. Therapeutic Innovation and Regulatory Science. 2016. Vol. 50. №1, Pp. 115-122. DOI: https://doi.org/10.1177/2168479015596020.
Li P., Lei H., Zhang C., Rao X., Huang S., Cao D., Zhou J., Wen J. (2026). Development and application of a digital intelligent platform for clinical trial management. Intelligent Pharmacy. 2026. Vol. 4. №1. Pp. 12-19. DOI: https://doi.org/10.1016/j.ipha.2025.09.002.
Sharma A. eSource and risk-based monitoring. Clinical Researcher. 06.2016. URL: https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/03/ACRP-Clinical-Researcher-June-2016.pdf (дата звернення: 06.04.2026).
Manasco P.K. Quality remote monitoring: the tools of the game. Applied Clinical Trials. 2016. Vol. 25, №6. URL: https://www.appliedclinicaltrialsonline.com/view/quality-remote-monitoring-tools-game (дата звернення: 06.04.2026).
Barnes B., Stansbury N., Brown D., Garson L., Gerard G., Piccoli N., Jendrasek D., May N., Castillo V. Adelfio A., Ramirez N., McSweeney A., Berlien R., Butler P.J. Risk-based monitoring in clinical trials: past, present, and future. Therapeutic Innovation and Regulatory Science. 2021. Vol. 55. № 4. Pp. 899-906. DOI: https://doi.org/10.1007/s43441-021-00295-8.
U.S. Food and Drug Administration. Oversight of clinical investigations – A risk-based approach to monitoring: Guidance for industry. 07.08.2017. URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring (дата звернення: 06.04.2026).
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). 09.11.2016. URL: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf (дата звернення: 06.04.2026).
Chaturvedi P.R. Critical utility of e-solutions in risk based monitoring. International Journal of Clinical Trials. 2016. Vol. 3. №4. Pp. 199-202. DOI: https://doi.org/10.18203/2349-3259.ijct20163957.
Agrafiotis D. K. et al. Risk-based monitoring of clinical trials: An integrative approach. Clinical Therapeutics. 2018. Vol. 40. №7. Pp. 1204-1212. DOI: https://doi.org/10.1016/j.clinthera.2018.04.020.
Hurley C., Shiely F., Power J., Clarke M., Eustace J.A., Flanagan E., Kearney P.M. Risk based monitoring (RBM) tools for clinical trials: A systematic review. Contemporary Clinical Trials. 2016. Vol. 51, Pp. 15-27. DOI: https://doi.org/10.1016/j.cct.2016.09.003.
Ehidiamen A.J., Oladapo O.O. The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines. World Journal of Biology Pharmacy and Health Sciences. 2024. Vol. 20. № 1. Pp. 321-334. DOI: https://doi.org/10.30574/wjbphs.2024.20.1.0789.
Chandan K. Advancing clinical data capture: embracing electronic data capture (EDC) for enhanced efficiency and quality. International Journal of Science and Research. 2023. Vol. 12. № 7. Pp. 1261-1264. DOI: https://doi.org/10.21275/SR23717190711.
Hirsch I.B., Martinez J., Dorsey E.R., Finken G., Fleming A., Gropp C., Home P., Kaufer D. I., Papapetropoulos S. Incorporating site-less clinical trials into drug development: A framework for action. Clinical Therapeutics. 2017. Vol. 39. № 5. Pp. 1064-1076. DOI: https://doi.org/10.1016/j.clinthera.2017.03.018.
Raja S. Digital tools in decentralized clinical trials: eConsent, electronic data capture, ePRO, and related technologies. International Scientific Journal of Engineering and Management. 2023. Vol. 2. № 10, Pp. 1-6. DOI: https://doi.org/10.55041/ISJEM01272.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Guideline for Good Clinical Practice E6(R3). 06.01.2025. URL: https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf (дата звернення: 06.04.2026).
Uriti S. Chapter 16. Computers in clinical development: clinical data collection and management. In Computer Aided Drug Development. 2024. Pp. 426-458. ThinkPlus Pharma Publications. DOI: https://doi.org/10.69613/3gxqxw38.
Stafford P.B., Garrett A. Using real-time data to drive better decisions, faster. Therapeutic Innovation and Regulatory Science. 2011. Vol. 45. № 4. Pp. 495-502. DOI: https://doi.org/10.1177/009286151104500410.
Zhang J., Sun L., Liu Y., Wang H., Sun N., Zhang P. Mobile device-based electronic data capture system used in a clinical randomized controlled trial: advantages and challenges. Journal of Medical Internet Research. 2017. Vol. 19. № 3, Article e66. DOI: https://doi.org/10.2196/jmir.6978.
Daher A. et al. A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data. PLOS ONE. 2023. Vol. 18. № 11. DOI: https://doi.org/10.1371/journal.pone.0294412.
Barnes S., Katta N., Sanford N. et al. Technology considerations to enable the risk-based monitoring methodology. Therapeutic Innovations & Regulatory Science. 2014. Vol. 48. № 5. Pp. 536-545. DOI: https://doi.org/10.1177/2168479014546336.
Kommaraju R.J. Optimizing data quality and compliance through integrated validation strategies for clinical systems. The American Journal of Engineering and Technology. 2025. Vol. 7. № 8. Pp. 299-306. DOI: https://doi.org/10.37547/tajet/Volume07Issue08-26.
Sahoo U., Bhatt A. Electronic data capture (EDC) – A new mantra for clinical trials. Quality Assurance. 2004. Vol. 10. № 3-4. Pp. 117-121. DOI: https://doi.org/10.1080/10529410390892052.
Paul S. Data integrity and quality in clinical trials. Revista de Inteligencia Artificial en Medicina. 2024. Vol. 15. № 1. URL: https://redcrevistas.com/index.php/Revista/article/view/266 (дата звернення: 06.04.2026).
Yamada, O., Chiu, S. W., Nakazawa, T. et al. (2024). Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture. Trials, 25, 384. https://doi.org/10.1186/s13063-024-08242-2.
Mitchel, J. T., Schloss Markowitz, J. M., Yin, H. et al. (2012). Lessons learned from a direct data entry phase 2 clinical trial under a US investigational new drug application. Therapeutic Innovation and Regulatory Science, 46(4), 464-471. https://doi.org/10.1177/0092861512449530.
Jiang, M., Zhao, S., Mei, Y., Fu, Z., Yuan, Y., Ai, J., Sheng, Y., Gong, Y. & Chen, J. (2025). Real-time, risk-based clinical trial quality management in China: development of a digital monitoring platform. Journal of Medical Internet Research – Medical Informatics, 13, e64114. https://doi.org/10.2196/64114.
Yamada, O., Chiu, S.-W., Takata, M. et al. (2020). Clinical trial monitoring effectiveness: remote risk-based monitoring versus on-site monitoring with 100% source data verification. Clinical Trials, 18(2), 158-167. https://doi.org/10.1177/1740774520971.
Rosenberg, L., Levaux, H., Levine, R. L., Shah, A., Denmark, J., Hereema, N., Owen, M., Kalk, S., Kenny, N., Vinson, G., Vergilio, J. A., Mims, A., Borate, U., Blum, W., Stein, E., Gana, T. J., Stefanos, M., Yocum, A., Marcus, S., Shoben, A., Druker, B., & Byrd, J. (2021). Streamlined operational approaches and use of e-technologies in clinical trials: Beat acute myeloid leukemia master trial. Therapeutic Innovation and Regulatory Science, 55(5), 926-935. https://doi.org/10.1007/s43441-021-00277-w.
Tantsyura, V., Dunn, I. M., Waters, J. et al. (2016). Extended risk-based monitoring model, on-demand query-driven source data verification, and their economic impact on clinical trial operations. Therapeutic Innovation and Regulatory Science, 50(1), 115–122. https://doi.org/10.1177/2168479015596020.
Li, P., Lei, H., Zhang, C., Rao, X., Huang, S., Cao, D., Zhou, J., & Wen, J. (2026). Development and application of a digital intelligent platform for clinical trial management. Intelligent Pharmacy, 4(1), 12-19. https://doi.org/10.1016/j.ipha.2025.09.002.
Sharma, A. (2016). eSource and risk-based monitoring. Clinical Researcher, June 2016. https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/03/ACRP-Clinical-Researcher-June-2016.pdf.
Manasco, P. K. (June 1, 2016). Quality remote monitoring: the tools of the game. Applied Clinical Trials, 25(6). https://www.appliedclinicaltrialsonline.com/view/quality-remote-monitoring-tools-game.
Barnes, B., Stansbury, N., Brown, D., Garson, L., Gerard, G., Piccoli, N., Jendrasek, D., May, N., Castillo, V., Adelfio, A., Ramirez, N., McSweeney, A., Berlien, R., & Butler, P. J. (2021). Risk-based monitoring in clinical trials: past, present, and future. Therapeutic Innovation and Regulatory Science, 55(4), 899-906. https://doi.org/10.1007/s43441-021-00295-8.
U.S. Food and Drug Administration (August 7, 2013). Oversight of clinical investigations – A risk-based approach to monitoring: Guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (November 9, 2016). Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Chaturvedi, P. R. (2016). Critical utility of e-solutions in risk based monitoring. International Journal of Clinical Trials, 3(4), 199-202. https://doi.org/10.18203/2349-3259.ijct20163957.
Agrafiotis, D. K. et al. (2018). Risk-based monitoring of clinical trials: An integrative approach. Clinical Therapeutics, 40(7), 1204-1212. https://doi.org/10.1016/j.clinthera.2018.04.020.
Hurley, C., Shiely, F., Power, J., Clarke, M., Eustace, J. A., Flanagan, E., & Kearney, P. M. (2016). Risk based monitoring (RBM) tools for clinical trials: A systematic review. Contemporary Clinical Trials, 51, 15-27. https://doi.org/10.1016/j.cct.2016.09.003.
Ehidiamen, A. J., & Oladapo, O. O. (2024). The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines. World Journal of Biology Pharmacy and Health Sciences, 20(1), 321-334. https://doi.org/10.30574/wjbphs.2024.20.1.0789.
Chandan, K. (2023). Advancing clinical data capture: embracing electronic data capture (EDC) for enhanced efficiency and quality. International Journal of Science and Research, 12(7), 1261-1264. https://doi.org/10.21275/SR23717190711.
Hirsch, I. B., Martinez, J., Dorsey, E. R., Finken, G., Fleming, A., Gropp, C., Home, P., Kaufer, D. I., & Papapetropoulos, S. (2017). Incorporating site-less clinical trials into drug development: A framework for action. Clinical Therapeutics, 39(5), 1064-1076. https://doi.org/10.1016/j.clinthera.2017.03.018.
Raja, S. (2023). Digital tools in decentralized clinical trials: eConsent, electronic data capture, ePRO, and related technologies. International Scientific Journal of Engineering and Management, 2(10), 1-6. https://doi.org/10.55041/ISJEM01272.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. (January 6, 2025). Guideline for Good Clinical Practice E6(R3). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
Uriti, S. (2024). Chapter 16. Computers in clinical development: clinical data collection and management. (2024). In Computer Aided Drug Development (pp. 426-458). ThinkPlus Pharma Publications. https://doi.org/10.69613/3gxqxw38.
Stafford, P. B., & Garrett, A. (2011). Using real-time data to drive better decisions, faster. Therapeutic Innovation and Regulatory Science, 45(4), 495-502. https://doi.org/10.1177/009286151104500410.
Zhang, J., Sun, L., Liu, Y., Wang, H., Sun, N., & Zhang, P. (2017). Mobile device-based electronic data capture system used in a clinical randomized controlled trial: advantages and challenges. Journal of Medical Internet Research, 19(3), e66. https://doi.org/10.2196/jmir.6978.
Daher, A., et al. (2023). A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data. PLOS ONE, 18(11). https://doi.org/10.1371/journal.pone.0294412.
Barnes, S., Katta, N., Sanford, N., et al. (2014). Technology considerations to enable the risk-based monitoring methodology. Therapeutic Innovations & Regulatory Science, 48(5), 536-545. https://doi.org/10.1177/2168479014546336.
Kommaraju, R. J. (2025). Optimizing data quality and compliance through integrated validation strategies for clinical systems. The American Journal of Engineering and Technology, 7(8), 299-306. https://doi.org/10.37547/tajet/Volume07Issue08-26.
Sahoo, U., & Bhatt, A. (2004). Electronic data capture (EDC) – A new mantra for clinical trials. Quality Assurance, 10(3-4), 117-121. https://doi.org/10.1080/10529410390892052.
Paul, S. (2024). Data integrity and quality in clinical trials. Revista de Inteligencia Artificial en Medicina, 15(1). https://redcrevistas.com/index.php/Revista/article/view/266.
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