Signant SmartSignals Unified Platform: eSource For A COVID Treatment Trial

An emerging biopharmaceutical company realized they needed help facilitating a Phase 2 trial for a COVID-19 treatment in critically ill patients. The study, conducted in the therapeutic area of Infectious Disease, involved an adult participant population across four sites in the United States, totaling 30+ participants. The aim was to address the unique challenges posed by the trial and population by optimizing technology.

The challenges faced included the risk of COVID-19 cross-contamination associated with paper data collection. To mitigate this, the sponsor sought to optimize study implementation by reducing the need for paper data collection, limiting cross-contamination risks, and minimizing staff time spent transcribing data. Another challenge involved establishing a rapid and straightforward consent process for both patients and legally authorized representatives. The sponsor needed to provide a simple consenting mechanism for hospitalized patients capable of consenting, as well as an efficient process for legally authorized representatives to provide consent remotely.

Furthermore, the study required the use of multiple eClinical solutions concurrently, posing a potential burden on-site staff. To address this, the sponsor sought a solution provider that could ensure a seamless and uncomplicated experience for site staff, a critical factor in site selection during a global pandemic.

Unearth how Signant Biotech's expertise was able to play a pivotal role in optimizing technology solutions to meet these challenges and streamline the Phase 2 trial by accessing the case study below.