Knowledge capture within the biopharmaceutical clinical trials environment

Purpose – The purpose of this paper is to provide an overview of knowledge capture in the biopharmaceutical industry, focusing primarily on the transition from paper-based to electronic data capture (EDC) systems. Design/methodology/approach – The paper draws on biopharmaceutical industry literature and data from example clinical studies to describe the issues involved in transitioning to EDC in the clinical trials environment. Findings – While electronic data capture systems provide greater efficiencies along the clinical trial supply chain, the industry is still far from achieving wide scale utilization of such technologies. The barriers to successful implementation are multifaceted, involving not only the information technology itself, but also user acceptance issues, lack of interoperability standards, and regulatory compliance. Major shifts in organizational culture and a unified effort within the industry will be necessary in order to derive full benefits from electronic capture systems in the future. Research limitations/implications – This study was limited in that case data from only one company was used to supplement the literature review. Further research is warranted to better understand the factors that facilitate adoption of electronic knowledge capture systems in the biopharmaceutical industry. Originality/value – While the need for knowledge management in the healthcare industry is indisputable, there has been remarkably slow progress in this area, and a dearth of research exploring implementation issues. The value of this type of inquiry is profound as it will help us better understand the issues in implementation and adoption, and ultimately to deliver more effective and safe drugs to the public in a more efficient manner