Applied Clinical Trials
Yashesh Mehta, Sciformix Corporation
Over the past decade global pharmaceutical companies have successfully established different sourcing models and service lines in emerging markets either through their local affiliates or service providers. While clinical trials were initially outsourced to these geographies to take advantage of their large patient population, today emerging markets offer a broad range of advanced skilled services that can support the entire clinical trial process. Outsourcing of data entry services soon expanded to data management, programming, scientific writing, and subsequently biostatistics, pharmacovigilance and regulatory operations.
The past decade has also seen a dramatic increase in the complexity and costs of clinical trials. The industry has tried to move away from the traditional on-site monitoring approaches and 100% Source Data Verification (SDV) to risk based approaches to help ensure subject safety and generate quality data. In 2013, the US FDA formalized Risk Based Monitoring (RBM) guidelines that define how monitoring can be proportionate to identified risk trends. Introduction of RBM guidelines and the sponsors’ need to innovate cost-effective monitoring techniques has drawn sponsors and service providers to consider technological solutions that identify risk trends. The global clinical trials industry is evaluating RBM to replace the resource heavy, reactive and costly on-site monitoring.