The Role of Predictive Models in Managing Operation Risk and Workload in Clinical Trial

Author:

Djali Sina1

Affiliation:

1. Integrated Data Analytics and Reporting, Janssen R&D

Abstract

Changes in the regulatoryenvironment and external factors, such as the recent COVID-19 pandemic, haveforced pharmaceutical companies and Clinical Research Organizations tore-evaluate how they engage with and support investigator sites. This paperdescribes using AI (Artificial Intelligence) based algorithms to model investigatorsite performance and create predictive analytics for workload and risks coupledwith key risk and performance indicators for clinical research professionals atSponsor. It describes how clinical operations can move to an operating modelbased upon dynamic approaches for monitoring studies and participating sites. 

Publisher

Society for Clinical Management

Subject

General Medicine

Reference16 articles.

1. 1. US Food and Drug Administration. Pharmaceutical quality for the 21st century a risk-based approach progress report. Published May, 2007. Accessed October 4, 2023. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/pharmaceutical-quality-21st-century-risk-based-approach-progress-report.

2. 2. Clinical Trials Transformation Initiative. Quality by design. Accessed October 4, 2023. https://ctti-clinicaltrials.org/our-work/quality/quality-by-design/.

3. 3. US Food and Drug Administration. FDA oversight of clinical investigations — a risk-based approach to monitoring. Published August, 2013. Accessed October 4, 2023. https://www.fda.gov/media/116754/download.

4. 4. European Medicines Agency. Reflection paper on risk-based quality management in clinical trials. Published November 18, 2013. Accessed October 4, 2023. https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-risk-based-quality-management-clinical-trials_en.pdf.

5. 5. TransCelerate Biopharma Inc. Position paper: risk-based monitoring methodology. Accessed October 4, 2023. http://www.transceleratebiopharmainc.com/assets/risk-based-monitoring/.

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