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Biography

Colleen is the CEO of Objective Clinical which is a clinical research strategy and management firm located in the Nashville Tennessee area that supports clinical research leaders in strategic and financial planning, regulatory compliance and optimization of research operations. She brings 25 years of experience in development, management and operational direction of clinical research organizations. She has held senior positions with international clinical research organizations (CROs) including specialty CROs. She served as a committee member for International Business Communications on their Speakers Board for healthcare administration topics, as a Biotechnology Advisory Member for Bates Technical College in Tacoma Washington, and a Board of Director member for Seattle’s Children’s Home. She has been a presenter at ACRP. Colleen is a graduate of the University of Tennessee, College of Business.

Abstract

The primary focus of clinical research is advancing science and to improve health outcomes. However, for a site or network to have ongoing success and support across the enterprise, the research program also must support overall business goals. There is a methodology to choosing the right clinical trials and the right technologies that fosters efficiency, productivity and enhanced compliance. Optimal study mix selection examples based on the research program’s attributes and goals will be presented and we will discuss how current and emerging offerings can help. Case studies include:

eConsent: This technology offers higher efficiency, consistency and quality with improved participant empowerment and understanding. Success depends on well managed implementation and staff adoption and transition from legacy processes.

Mining EMR with Objective Criteria: The monitoring and analysis of records can help identify qualified patients with less co-morbidity. Understanding the potential to enhance study success through better matching of sites and sponsors by using carefully selected enrollment criteria, while recognizing the challenges of medical data input quality within the EMR.

Wearable’s & ePRO Data: These emerging technologies offer dramatic potential to capture timely research data remotely and continuously, reducing the facility and labor costs and the overall study time required for on-site trials.

Remote Monitoring: Embracing the time saving benefits for data collection by remote monitoring, while ensuring the clarity of the roles of the clinical study team, is key to making this technology and practice work well.