Premarket Approval Trial
When a leading developer, manufacturer, and supplier of premium diagnostics products, medical imaging systems, and surgical products needed assistance with a Pivotal Study, they retained Dyad Systems to provide project execution services for their high profile, first-of-its-kind Class III device. For the Pivotal Study of this cancer screening diagnostic system, that spanned three years and involved 22 sites and over 3,500 subjects, Dyad provided Lead CRA project leadership, site initiation, monitoring, and closeout. Additional services included:
Databases supporting blinded-reader sub-studies for image evaluation
On-going ad-hoc analysis of patient demographics and cohort enrollment tracking
100% Source Monitoring
Study and Trial Master File
The study was FDA-approved in late 2012, and FDA BIMO site audits were conducted with no deficiencies identified. Dyad recommended and implemented the development of an Electronic Study Portal—a centralized electronic TMF that fostered a collaborative team environment. Dyad’s services, which were all delivered on time, led to minimal staff turnover with no CRA changes during the two years of active enrollment and one-year follow-up.