Site & patient solutions case studies

A biotechnology company was attempting to recruit 40 paediatric patients in a US phase II oncology study.

Large pharmaceutical company was running a phase II study to assess the efficacy of a study drug in paediatric patients with a rare degenerative genetic disorder. The study required weekly infusions for more than 50 patients in the UK.

A mid sized Pharma organisation was conducting a Phase Ib trial with plans to enroll 188 Non Small Cell Lung Carcinoma patients in Cohort B.

We developed and facilitated a series of Patient Partner Workshops™. Patients engaged in a variety of unique activities designed to stimulate open, honest dialogue among the group.

A mid-sized biopharmaceutical sponsor was conducting a phase 3 study on CDKL5 deficiency disorder, a rare
genetic seizure disorder in children.

ICON partnered with a drug development sponsor to conduct a multicenter, randomised, double-blind, placebo-controlled,
proof of concept study of the efficacy and safety of a treatment for patients with fibromyalgia.

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.