Our client was developing a vaccine for a seasonal infectious disease. They planned a trial to assess the product’s efficacy and immunogenicity. The trial involved a number of interim analyses, and so the project team needed to set up an Independent Data Monitoring Committee (IDMC). However, they lacked direct experience in managing these. Given the seasonality of the disease, our client also faced significant challenges in patient recruitment, leading to tight timelines.
Read how Cytel provided a service which included the selection of the IDMC members and their contract negotiation and management, together with Independent Statistical Center (ISC) activities.