This document discusses Spaulding Clinical's approach to electronic data capture (EDC) in phase 1 clinical trials using Real World Solutions (RWS) and medical devices. Key points: 1) Spaulding Clinical uses fully integrated EDC where data is captured electronically from the source (e.g. ECG, vitals, labs) rather than later entered, ensuring accurate and timely data collection. 2) Their approach aims to maximize automation so computers perform routine tasks, while humans focus on patient-centered work. 3) Spaulding is developing technologies like a hand-held ECG device that uploads securely to their system, eliminating errors from manual data entry.