Case studies

A global biopharmaceutical company was conducting a set of post-marketing studies to determine the safety and transference of a drug taken for autoimmune disorders during pregnancy and breastfeeding.

A mid-size pharmaceutical company conducted a phase II study to compare treatments in 52 adult patients with plaque psoriasis. The treatment was to be applied twice daily for 3 weeks in 10 US sites.

ICON was engaged by a large pharma sponsor late in the study process to provide solutions to support the recruitment of 28,000 patients for two global mega Cardiovascular Outcome studies. ICON developed and implemented an plan including recruitment and retention planning, tactical implementation, vendor oversight processes and direct site support to ensure key milestones were met.

A leading biotechnology company contracted ICON to run a large number studies across Phase I to Phase III programs in a number of therapeutic areas including oncology, cardiovascular and dermatology.

A large, multi-national pharmaceutical company received an FDA finding in relation to low protocol training compliance for site staff. Following analysis, the issue was identified as being the use of multiple methods and the difficulty in tracking and reporting on training compliance.

The customer had received a warning letter from the US Food and Drug Administration (FDA) in relation to investigator non-compliance with the study protocol in the execution of its trials. As part of the root cause investigation, it was identified that protocol training compliance was only 73% across the customer’s portfolio of trials.

A small pharmaceutical company was conducting a Phase II study to evaluate the safety, efficacy and tolerability of an oral study drug to be taken twice daily. The study was targeting 32 adult patients (16-60 years old) with an inherited rare neurodegenerative movement disorder.

A biopharmaceutical company ran multiple Phase II/III orphan drug studies evaluating a drug for a rare pulmonary disorder. The treatment regimen required daily oral dosing and safety blood draws every 2 weeks with a treatment duration of up to 2 years.

A large biopharmaceutical company with a Phase III trial enrolling 430 advanced Gastric Cancer patients contracted ICON to
support patient enrollment.

Accellacare was contracted by a large pharma organisation to recruit and provide In-Home Services to paediatric patients with autism.

ICON’s Accellacare In-Home Services were used across more than 50 sites in the United States to conduct blood draws and nasal swabs, collect vital signs, and monitor for changes in health, medications, or hospitalisation for a two treatment studies in patients with COVID-19.

A biotechnology company, dedicated to transforming Women’s Health, was running a phase 3 study in the treatment of moderate-to-severe vasomotor symptoms in postmenopausal women with a global enrollment target of 1,200 patients.