DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.

With the widespread adoption of digitized regulated content management systems, the digitization of the investigator site documents and data collection will be the next horizon to be mastered. Whether it is the document management or the inspection, audit or retention of records, digitization will allow systems, tools and business processes to increase compliance with regulations. With new processes and systems, best practices and patient education will be key to successful adoption. The adoption of technology solutions will also impact the patients. This symposium will explore the need for communicating with patients through multiple channels on the rise of mobile and digital technology and investigate related questions. We will address the need for patient education and examine how we can best share this information with patients in a health literate manner, including the use of patient-facing infographics. The eConsenting process has demonstrated benefits along the continuum of the clinical trial, among them benefits in patient enrollment and engagement as well as regulatory compliance. Examples from several recent implementations will be presented to demonstrate the potential return on investment of an eConsent system and outline the positive impact this process can have on inspection findings.