ICON has extensive experience in cardiovascular clinical research trials across the entire drug development spectrum.
There is still significant unmet need within select cardiovascular/metabolic (CVM) disorders. Unfortunately, the cost of developing drugs and devices in this area has been rising steadily. ICON, a full service provider, takes a data-driven approach to developing strategies that will cut timelines and costs… from First-in-Human (FIH) studies through post approval.
We have over 25 years of experience conducting cardiovascular trials, with particular emphasis on key cardiovascular/metabolic indications: heart failure, lipid disorders, diabetes, renal insufficiency and renal transplant, arrhythmia, and rare diseases.
ICON's Cardiovascular Experience in the Last Five Years
Innovative Approaches & Best Practices
Our services include:
- Drug & Device Development - Therapeutic advisors in cardiovascular disease available to consult with sponsors as well as to provide leadership to study teams
- Medical Device & Diagnostics Research (MDDR) - Regulatory, quality, and clinical project management staff to help guide, manage, and monitor device trials
- Adaptive Study Design - Market-leading simulation software and methods to perfect trial design
- Phase I Research - A 120-bed unit with pharmacy, labs, and ECG system
- Feasibility Assessment - A global team of experts and data scientists using an evidence-based approach to accurately estimate enrollment and study timelines
- Site Identification / Relationships - A wholly-owned site network and relationships with an alliance of 100+ hospitals and 900 specialists
- Patient Recruitment & Retention - Multiple strategies for proactively managing recruitment and preventing withdrawal of consent or patients lost to follow up
- Patient-Centric & Targeted Site Monitoring - Cost-effective strategies for focusing on those activities that have the greatest potential to improve patient protection and data reliability
- Imaging - Advice on including imaging biomarkers and experience in all cardiovascular imaging modalities
- Endpoint Management & Adjudication - Independent group processes endpoints in less than 30 days, on average
- Central Laboratory Services - Global central lab with industry-leading accuracy for CVM endpoints
Clinical Trial Experience
Our clinical trial experience includes but is not limited to the following cardiovascular indications:
- Acute coronary syndrome (ACS)
- Atrial Fibrillation
- Cardiovascular Prevention
- Cerebrovascular Disease
- Congestive Heart Failure
- Coronary Artery Disease
- Myocardial Infarction
- Peripheral Artery Disease
- Pulmonary Artery Hypertension
Cardiovascular Therapeutic Area Group
ICON has a global team of in-house Cardiovascular experts, known as a Therapeutic Area Group (TAG), who are highly-experienced in clinical research and drug development. The group includes representatives from all critical functional areas and oversees trial operations in order to anticipate and proactively address potential roadblocks.
In addition to providing support and guidance to the study team, the other main responsibilities of the TAG teams include:
- Global project feasibility
- Protocol development, review and evaluation
- Clinical trial planning
- Therapeutic training and advice
- Project oversight
- Consulting, medical monitoring and advisory board representation
- Interpretation of the clinical data
- Completion of the clinical study report
Our global investigator database includes over 2,800 cardiovascular investigative sites across more than 55 countries. As such, we have established solid working relationships with leading cardiovascular sites in all regions of the world, enabling us to provide our sponsors with efficient recruitment strategies tailored to each individual study.
We have worked with a wealth of speciality investigators in multiple areas of cardiovascular disease.