Quality Assurance and Remote Site Audits in Veterinary Clinical Field Studies

As clinical field studies serve as pivotal data to obtain a marketing authorisation for animal health products, quality requirements are abundant. Regular audits enhance the quality of studies and thus facilitate the review process by the regulatory authorities, by providing confidence in the data integrity of studies. In the past year, the ability to perform physical on-site audits was challenged due to travel restrictions and social distancing rules associated with the COVID-19 pandemic. Subsequently, remote site audits became a well-accepted and convenient alternative to conventional physical on-site audits. Claudia Laskowski and Klaus Hellmann at Klifovet will share some experience on what to consider when planning and conducting remote site audits for veterinary clinical field studies.