Case Study

Optimizing Direct-To-Patient Supply Management: ClinChoice And 89Bio

audit management

The CRO ClinChoice and the sponsor 89Bio were conducting a phase II, randomized, double-blind, placebo-controlled study to explore the efficacy and safety of investigational drug X in subjects with severe hypertriglyceridemia (SHTG). The companies needed to pivot to a decentralized protocol during the pandemic or face trial disruption.

Needing to maintain trial integrity during the COVID-19 pandemic, while prioritizing patients' safety and their continued participation in the study were key factors to initiating a Direct-to-Patient (DtP) solution. This allowed the patient to choose to be dosed on site or at home.

However, with 30 sites and 200 patients across both the US and Canada, the trial’s hybrid approach needed to adhere to differing regulatory guidelines. It also required the ability to provide flexible dispensation preferences (i.e., home or site based on each dosing visit), and quick response to remote patient needs.

ClinChoice and 89Bio needed a partner that could provide the ease and flexibility to rapidly execute DtP, while ensuring Investigational Product (IP) supply management and optimization.

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