A sponsor for a pivot trial spanning three different continents asked Sunnikan for help with ensuring the trial met quality standards.
Sunnikan drew up a schedule of ad hoc audits for the primary stakeholders (sponsor, coordinating CRO, investigation sites, medical imagining centralisation, data management, statistics, etc.) and carried out the audits in question throughout the trial’s life-span.
As medical imaging was the primary evaluation criterion, this aspect was taken into particular consideration, with French, European and American regulatory frameworks also taken into account.
Cindy BERNAT ARLAUD