V3I5P77

Data-Driven Optimisation of Investigator Payment Compliance and Operational Efficiency in U.S. Clinical Trial Systems 

Oluwatosin Akintola^1*, Adeyemi Samuel Akintola²

Abstract

Investigator and site payments remain a consistent source of delays, administrative challenges, and compliance risks in U.S. clinical trial operations. In numerous organisations, payment processing is fragmented across various systems, including clinical trial management systems, electronic data capture platforms, contracting repositories, enterprise resource planning tools, and regulatory reporting workflows. This fragmentation results in delayed reimbursements, manual reconciliation efforts, inconsistent milestone verification, weak audit trails, and disclosure discrepancies, which can contribute to broader issues in study execution. This paper proposes a data-driven optimisation framework to enhance investigator payment compliance and operational efficiency in U.S. clinical trial systems. The framework integrates contract and budget data, trial-activity evidence, invoice and accounts-payable records, regulatory-reporting indicators, disclosure controls, and site-performance histories into a unified architecture designed for compliance. Predictive analytics are employed to estimate the risks associated with payment delays, documentation failures, disclosure mismatches, and site friction. These risk indicators are incorporated into an optimisation layer that prioritises payment authorisation, analyst workload distribution, exception management, and escalation timing, all within operational and regulatory constraints. The framework is specifically tailored to the U.S. environment, where payment governance intersects with FDA clinical investigator financial disclosure requirements, ClinicalTrials.gov registration and results reporting obligations, CMS Open Payments transparency standards, and ICH E6(R3)-aligned expectations for fit-for-purpose computerised systems and risk-based trial oversight. The authors assert that investigator payment compliance should be regarded not merely as a back-office finance task but as a real-time operational control issue with significant implications for site sustainability, trial startup speed, audit preparedness, recruitment continuity, and the trust between sponsors and sites. The paper presents a conceptual system architecture, mathematical formulation, implementation roadmap, governance structure, and evaluation framework to support sponsors, contract research organisations, academic medical centres, and site networks.

Keywords:

Clinical trial operations; investigator payments; compliance analytics; Open Payments; ClinicalTrials.gov; operational efficiency; optimization; site management; risk-based quality management