Clinical study management model: case study of in-house and fully outsourced study.

Abstract

The trend of outsourcing services has been increased in various fields including R&D and clinical research a few decades ago. Nowadays, both in-house and outsourcing clinical studies are still available in the market and pharmaceutical companies. This paper aims to understand management and challenges in two different resourcing model of the clinical study. One in-house observational clinical research and another fully outsourced observational clinical study have been selected as the case study. Two clinical project managers from each study have been interviewed to collect data and explore the real case in five topics including management model, governance, stakeholders engagement, challenges, and experience sharing about resourcing models. The selection of the management model must be depended on strategy, objective, and available resources. The in-house model suits for the keeping relationship and experience while full-outsourcing for efficiency. The appropriate tools and activities are required to governance and oversee the quality and performance of the project. The partnership program is recommended for the outsourcing model. Communication is a key success. The project quality of a fully-outsourced study should be more considered from a company perspective because the study has not been fully managed by the sponsors. The technical skills and socio-cultural skills enhance the project manager to manage the clinical study and work together with all stakeholders. The paper provides an example of both in-house and fully outsourced clinical studies to understand management, challenges, and recommendation for the selection of the resourcing model and improvement for a future clinical study.