Article | September 16, 2016

Managing Increasing Complexity In The Clinical Trial Industry

Source: Oracle Health Sciences
clinical trial data management and risk management

By Craig Morgan NZCS, MBA (Hons), PMP, goBalto, Inc.

With outsourcing of trials estimated to exceed 70% by 20202, and recent data from clinicaltrials.gov showing 46% of registered trials being conducted entirely outside the US, as compared to 39 percent taking place in the US exclusively, it is not surprising to find 72% of clinical trials running more than one month behind schedule. 

In this constantly evolving environment it is not surprising that the task of managing global trials is more demanding than ever and increasingly requires a robust risk management strategy from the start. Interestingly, while most of the industry's risk management efforts have focused on post-marketing drug safety3, the clinical trial process holds a broad array of other potential risks that could jeopardize a company's multi-million-dollar product development investment—risks such as site staffing shortages, patient recruitment issues, logistical problems with drug supplies, or regulatory delays.