Therapeutics case studies
How we maximise the value of our clients' development approach while reducing costs and timelines
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.
Ensuring protocol compliance in an Alzheimer’s study
A drug development sponsor sought help in recruiting patients for a study on the efficacy of a recombinant humanised Igg4P monoclonal antibody in prodomal to mild Alzheimer’s disease (AD).
Optimising a fully decentralised Alzheimer’s study through Digital Risk Detection
ICON operationalised a fully decentralised clinical trial for a midsized pharmaceutical company running a proof of concept to evaluate self-directed scalable electronic health platform methods for communicating Alzheimer’s Disease (AD) gene and biomarker results.
Successfully completing recruitment in an early Alzheimer’s disease study
ICON conducted a phase 3 multicentre, randomised, double-blind, placebo-controlled study of the efficacy, safety and biomarker effects of a compound in patients with early Alzheimer’s disease (AD) and APOE4/4 Genotype. The study encompassed 99 sites in 9 countries in the US and Europe.
Navigating complexity to achieve clinical trial success
ICON is conducting a global, phase 1/2a clinical trial for a small biotech company to evaluate potential treatment for Parkinson disease (PD).
Wearables and remote monitoring case study
A sponsor asked ICON to assess the feasibility and usability of wearables for measuring cough in respiratory patients, ensuring data streams were fit-for-purpose and capturing patient feedback on device acceptance.
Collaboration accelerates rare disease trial delivery
How commitment to partnership overcame historical, layered operational challenges.
Saving a lean biotech more than $4 million with strategic regulatory support
A US-based clinical stage biotech company had several 505(b)(2) NDA assets in development for rare diseases. This very small biotech operated with a lean team which did not have the necessary regulatory expertise to manage regulatory strategy and submissions.
Streamlining participant enrolment to address cohort-specific shortfalls
A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues that were overcome through collaboration and communication.
Imaging process boosts efficiency in oncology device trial
A prominent medical device company was conducting a feasibility study for a device to improve accurate identification of peripheral pulmonary nodules in high risk adult patients. Quality imaging data from multiple sources was critical to the study’s success and ICON helped manage the imaging data for each participant.
Recruitment success in a challenging phase 1 osteoporosis biosimilar study
Despite effective treatments, osteoporosis still needs better, affordable options. A sponsor ran a 3-arm, double-blind study on a denosumab biosimilar in 225 healthy men over 10 months at two ICON sites.
Consolidation of multiple protocols into a single LTE oncology study
To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required.
Integration of multiple oncology studies into a single OLE study
An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study.