T-37: Remote Site Management - A Rising Star in Our Clinical Research Ecosystem

Poster Presenter

Melissa B Mielcarz

AD, Clinical Operations
QuintilesIMS
United States

Objectives

To characterize the impact of remote site management on the evolving clinical research ecosystem.

Method

We studied the impact of remote site management on study operations, stakeholder interaction and engagement, data quality, patient safety and study costs. Analysis included a review of literature, stakeholder assessments and a review of risks and success factors.

Results

Our multi-pronged analysis confirmed that remote site management positively affects all stakeholders in clinical research (sponsor/CRO, site, patient, and regulator) and their dynamic relationship. Overall, remote site management is improving data quality, patient safety, stakeholder interaction, reducing costs, and improving site engagement and adherence. Technology and the ability to target both research naïve and research savvy sites to meet their specific needs were identified as underlying themes that have a progressively important role in successful remote site management.

Conclusion

With the evolution of technology and the importance of assessing the use of medicines in a real world setting, the need for more cost effective, less interventional models that still meet the needs and expectations of stakeholders is critical. While tremendous progress has been made over the last decade, continued advancements in technology that are both affordable and scalable are integral for full adoption across the industry. Additionally, continued guidance and support to ensure compliance must be generated and widely distributed.