ADAPTIVE RISK MANAGEMENT MECHANISM IN THE ACTIVITIES OF CONTRACT RESEARCH ORGANIZATIONS

Abstract

The article provides a comprehensive study of the transformation of risk management systems within contract research organizations (CROs) operating under martial law in Ukraine. The relevance of the research is driven by the critical misalignment between traditional static risk management models and contemporary extreme realities. It is established that outdated approaches pose systemic threats not only to patient physical safety but also to the validity of scientific data, which is unacceptable under International Council for Harmonisation - Good Clinical Practice (ICH-GCP) standards. The author performs a profound systematization of specific war-related risks, classified into operational-security, infrastructural-logistical, and regulatory-ethical groups. Furthermore, their cumulative impact on the investment attractiveness of the domestic clinical trials market and the closure rates of active protocols is analyzed. The scientific novelty of the study lies in the theoretical substantiation and development of an original adaptive management mechanism. The model is based on the implementation of a dynamic “trigger matrix,” which enables the automated transition between three operational resilience scenarios: “Stable Adaptive,” “Hybrid Resilience,” and “Crisis Relocation.” The algorithms for switching CRO operational modes depending on the intensity of destabilizing factors (such as blackouts, patient migration, and the intensity of hostilities) are described in detail. Particular attention is paid to the role of digital transformation as a fundamental facilitator of adaptability. It is proven that the use of cloud environments (specifically Microsoft 365 and SharePoint) for maintaining electronic Trial Master Files (eTMF) mitigates the risks of primary documentation loss and ensures a transparent audit trail for international sponsors. The practical significance of the findings lies in the possibility of integrating the proposed five-stage “CRO Adaptive Cycle” into the Standard Operating Procedures (SOPs) of research centers. This integration ensures the continuity of the clinical process, optimizes logistical costs by 40–60%, and maintains high levels of trust among global pharmaceutical companies in Ukrainian research sites as reliable partners within the global R&D sector. The implementation of these adaptive solutions serves as a strategic tool for maintaining the stability of the high-tech medical business and guarantees the long-term protection of intellectual property and patient interests in a high-risk environment.