Biorasi implemented various layers of risk mitigation to assist in offsetting any foreseen compliance issues. To counteract patient non-compliance during summer months, summer enrollment was planned to incorporate a higher percentage of northern states where temperature severity is not as commonly noted. Furthermore, Biorasi’s feasibility process was two-fold incorporating both our project management and clinical teams from the get-go to ensure site enrollment estimates were as accurate as possible to realistically forecast expected enrollment and discontinuation numbers. Extensive site and subject education was incorporated into the study to ensure subjects were actively engaged in complying with study requirements and to ensure sites were equally well-trained on effective means of subject communication throughout the study.
The study was able to surpass initial enrollment projections, enrolling 963 subjects in under 5 months. With the incorporation of 5 study monitors to effectively train and track site progress and subject compliance, sites were able to successfully meet their enrollment goals and avoid unnecessary subject discontinuations due to treatment failures and subject non-compliance.