France's leading company
in clinical quality management
International
Sunnikan is looking for Clinical Research Quality Management Consultants
In 2020, Sunnikan worked on
100
projects
110
audits
in 25
different countries
45
training sessions
60
regulatory support projects
Our training programmes
As a training body, Sunnikan offers regulatory and quality training sessions
Our regulatory monitoring
Sunnikan offers monitoring and support tools to help companies keep up to speed on their regulatory obligations
Case studies
A pharmacovigilance audit on an international scale
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 series of audits spanning three continents
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
Ten audits in a month for the same clinical trial
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