Therapeutics case studies

Learn more on how we bring life changing therapies to market.

Providing empirically based guidance and built-to-spec models and solutions across every phase of clinical research and lifecycle management for therapeutic development.

Improving early phase oncology clinical trial design

This case study explores two Bayesian model-assisted designs in the context of early phase oncology clinical trials, focusing on their application and impact on study design. It includes a review of each design’s operating characteristics, proposed amendments, and simulations.

Chronic Myeloid Leukaemia

As a result of the multifaceted communication approach with sites and a strong partnership between ICON and sponsor, the study met its protocol-specified enrolment goal just 9 days beyond contracted Last Patient In date (LPI).

Driving payer education and awareness

ICON delivered a multifaceted omnichannel awareness campaign to provide a seamless customer experience between print and digital channels for a drug to treat PPD.

Rapid manuscript development and delivery

Through close collaboration with a client, the ICON team provided the support necessary to advance a critical COVID-19 manuscript from outline through submission to acceptance in only 20 days.

PKU-specific HRQol Questionnaire Development & Validation

ICON developed the first PKU-specific Quality of Life questionnaire available and validated in four age groups and seven languages.

Leveraging Immuno-Oncology real world data

ICON supported a randomised phase 3 study to examine the study drug in combination with nivolumab vs chemotherapy in patients with checkpoint inhibitor refractory non-squamous NSCLC.

Successful adaptation to complex dose escalation

ICON was selected by a mid-size biotech company to support a phase 1 dose escalation and cohort expansion study of an immune checkpoint inhibitor, in patients with advanced solid tumors. Mid-study, the sponsor was acquired by a large pharma company to which ICON has efficiently supported the transition to the evolving sponsor business model and operations.

Human Cytomegalovirus Vaccine Development

A pharmaceutical client needed to better understand patient perspectives, concerns and awareness of that could impact the development of a vaccine for Human Cytomegalovirus (HCMV).

H1N1 vaccine study

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

Exceeding recruitment timelines

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.

Rapid mobilisation to advance COVID-19 vaccine development

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

Successfully completing CGT study recruitment

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.