In order to ensure compliance with the regulations in force, the French parent company of an international pharmaceutical laboratory asked Sunnikan to carry out the audit for its distributors’ pharmacovigilance activities around the world.

Frédérique ALBOUY-NAVARRO

Operations Director

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 frameworks also taken into account.

Cindy BERNAT ARLAUD

Operations Director

As part of its plans to demonstrate progress made in a pivot trial to a potential American partner, the trial sponsor asked Sunnikan for help with carrying out ten audits of the trial’s primary stakeholders.
Drawing on a team comprised of a dozen consultants, and its standardised auditing methods and report writing system, Sunnikan carried out all ten audits in just a month, providing a general overview and detailed snapshot of the trial’s progress so far.

Catherine MÉRAT

Operations Director