Case Study: Large Pharmaceutical Company expands patient access with Clinical Ink

Guiding Protocol for Research Naive Sites to Expand Patient Access

Large Pharmaceutical Company wanted to run a large Phase IV post-marketing study through the in-house clinics of a U.S. drug store chain, but needed a way to guide protocol execution for medically trained, research naive nurses and clinicians. It also wanted to remove site responsibility for storing and managing paper source documentation, and to streamline randomization. The company worked with Clinical Ink and its SureSource eSource, eCOA, and ePRO platform.

Clinical Ink developed a customized eSource study with built-in guidance and automatic edit checks to support protocol execution and data quality at research naive sites. It also integrated eSource with IVRS to enable push-button randomization from each form and electronic capture of source documents. The result was 300 sites enrolling more than 12,000 subjects to date, with significantly expanded patient access across the U.S.