The Clinical Trials Unit
Defining, Staff Assessment and Scheduling Restructuring for Operational Efficiency
Among the drivers for change is a decrease in research funding, a factor that triggers additional cost containment measures. Increased requirements imposed by regulatory authorities and Institutional Review Boards (IRBs), increases in the expertise required to plan and execute clinical studies and increased study site expenses are also significant factors. Changes in the structure of research organizations designed to decrease costs and improve efficiency are valuable mechanisms for coping with these factors.
Enterprise Governance: Centralized vs. Decentralized
In the traditional model, research organizations function within a decentralized (silo) operational and administrative model. Research-specific activities are scattered over several different departments and research centers throughout the academic medical center. In this model, a common problem is the lack of adequate training on research requirements for senior management assigned research responsibilities. Departmental training programs may not be equipped to adequately cope with the complicated clinical research regulatory environment.
Decentralized (silo) operational models are often highly inefficient, and may lead to clinical research work products being completed in duplicate or triplicate work streams, completed incorrectly, or noncompliant with regulations. These problems are often addressed by implementing the wrong solution. For example, internal operational and administrative gap analyses lead many academic research institutions to compensate for decentralized model deficiencies with increased staffing or implementation of new technologies or software. In contrast, moving towards a centralized and hybrid model can reduce indirect operating costs, reduce cycle times and increase overall patient satisfaction.