Polish medtech company Nestmedic has chosen Curavit Clinical Research to spearhead the US clinical study of the remote prenatal monitoring solution, PregnaOne.
The non-significant risk (NSR) trial is set to enrol 50 expectant mothers over 11 months across the country to assess the effectiveness and safety of the solution when used at home.
This foundational study aims to gather evidence to facilitate upcoming regulatory clearance in the US.
Curavit will oversee all trial aspects, including institutional review board (IRB) submissions, site choosing, data management, contract and monitoring, selection of clinical data capture software, data analytics, as well as the clinical study report (CSR) preparation.
Nestmedic CEO Jacek Gnich said: 鈥淲e are building technology with empathy at its core. Curavit鈥檚聽innovation-forward approach, medical device expertise, and deep clinical trial experience make them the ideal partner to run this pivotal study in the US.鈥�
At least three clinical sites will be chosen, focusing on participant diversity in terms of geography and demographics.
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By GlobalDataCuravit noted that a centralised healthcare provider (HCP) data review and adjudication process implementation will take place to ensure the quality and consistency of the data.
Curavit Clinical Research CEO and co-founder Joel Morse said: 鈥淲e are honoured to support Nestmedic in bringing PregnaOne to market.
鈥淭heir mission to improve prenatal care through remote monitoring perfectly aligns with Curavit鈥檚 vision to partner with innovative medical device companies that are working to expand access to healthcare.鈥�
In 2023, Curavit Clinical Research introduced a Health Economics and Outcomes Research (HEOR) service for clinical studies.
In the same year, MedRhythms chose Curavit as its聽virtual contract research organisation (VCRO)聽for a trial of its MR-001 neurorehabilitation system.
