A Purpose-Built eCOA For Complex Clinical Studies: Reduce Site And Patient Burden In Gastroenterology Trials

The accelerating complexity of gastroenterology protocols has far outpaced the electronic clinical outcome assessments (eCOA) industry. Eligibility decisions based on data from both electronic patient-reported outcomes (ePROs) and clinician-reported outcomes (ClinROs), and derived through calculations based on compliance and complex scoring, are increasingly common. Patients are overwhelmed, sites are overburdened, and Sponsors are struggling to achieve even modest enhancements in the site and patient experience.

Fortunately, there’s a better solution. A system that incorporates eCOA software including patient engagement tools, such as bring-your-own-device (BYOD) for patients at home, a full-service site device for ClinROs and ePROs collected at visits, and an intuitive and fully customizable reporting portal for remote monitoring and data surveillance can help ease study complexity. Such product design tools and service delivery methodologies can also be applied specifically to a gastrointestinal (GI) Therapeutic Library Solution. This GI Library can be deployed and customized quickly and on demand within a unified platform.

A purpose-built solution designed to overcome the significant, but typical, challenges of a complex GI trial enables a better deployment experience and improved trial conduct.