Case studies

A sponsor approached ICON during an influenza pandemic in Mexico to conduct a randomised, placebo controlled vaccine study with an investigative pandemic H1N1 vaccine.

ICON was awarded a global study for Major Depressive Disease (MDD) in over 600 adult subjects. Enrollment began during the COVID pandemic and despite challenging protocol requirements, IMP expiry date and database lock requirements, ICON reached LPR and DBL closed five months early.

COA Repository, revolutionizing the management of COAs within the sponsor’s clinical trials.

ICON supported a phase 1/2/3, single-arm, open-label, multi-site, single dose in patients with transfusion-dependent ß-thalassemia. ICON overcame patient recruitment challenges due to the complexity of the study and sites with limited experience with CRISPR-Cas9 modified gene therapy. All planned milestones were met, and first patient randomised was per plan.

ICON was approached by a drug development sponsor to conduct a global, phase 3 trial in an adult patients with primary immune thrombocytopenia. The trial was part of a four-program study with challenging recruitment timelines.

The sponsor contracted ICON to conduct a randomised trial using a traditional site-based approach to identify the target dose and investigate the safety, tolerability and efficacy of three doses of an investigative compound administered subcutaneously for the treatment of lupus nephritis.

ICON was approached by a large pharmaceutical company to conduct a fully decentralised placebo-controlled trial, focused
on demonstrating that the drug reduced symptom burden in patients with heart failure.

A biotech company contracted ICON to conduct a large phase 3 study in Cell Gene Therapy (CGT) involving 532 patients.

ICON assisted in the recruitment of participants for a hot flash study that had a set of complex eligibility requirements.

The manufacturer consulted ICON, which had been providing full-service clinical coverage for the PMA study, to economically and seamlessly transition the PMA study participants to the mandated PAS.

The MDDR team developed a study protocol and start-up plan that enabled execution several months faster than a typical study. The team also transitioned from a PMA study to a PAS study.

ICON was awarded a study in an adult patient population with Fibrodysplasia Ossificans Progressiva (FOP), an ultra-rare indication. Despite complex study logistics ICON’s proactive site and patient support strategy enabled recruitment to be completed ahead of schedule.