We are a valued supporter to our partners on the path to vaccines development and approved treatments.
New and re-emerging infectious diseases continue to rise and pose a threat to global health. In the last 50 years, many unknown disease agents have been identified.
Our global team of experts have built up extensive vaccine experience. This enables us to anticipate the challenges in your drug development plan. We drive milestone success ensuring high quality deliverables within budget.
ICON's Vaccine Experience in the Last Five Years
225Vaccine studies conducted globally
300,000+Patients spanning vaccine types, populations, indications
3,800Vaccine experienced sites in over 40 countries
Experience Our Partners Can Trust
More than 35% of our clinical operations employees have experience in infectious disease trials. Over 100 of our Project Managers and 4 leaders are dedicated to the infectious disease portfolio of clinical studies. We conduct in the region of 20–50 vaccine trials per year, enrolling over 300,000 subjects across approximately 3,800 investigator sites.
- Awarded “Best CRO in Vaccines” at the World Vaccines Conference in 2014 and 2017
- Recently led the development of 14 vaccines resulting in FDA/EMA approvals
- Prime contractor for the US Government for 25 years
- Qualified provider for thr Bill and Melinda Gates Foundation. Our broad portfolio of services and global footprint also serve the needs of other Global Health organisations such as Welcome Trust, Global Fund and CEPI.
- Ranked top CRO in CenterWatch’s Global Investigative Site Survey. Rated at or above a 9 (on scale of 1-10, 10 being the highest score) for project delivery, project management proactivity, and overall customer satisfaction with our vaccines.
- Selected by the FDA to validate Patient Reported Outcome (PRO) Endpoints for Antibacterial Drug Trials. Tasked with the development of qualified instruments for each disease that can be used by drug developers for the qualified context of use in IND and NDA/BLA submissions.
Areas of Expertise
Indications (Seasonal, Vector, Sexually-Transmitted, Enteric, Other Viral & Bacterial)
Adaptive Design Trials
We are the only full service CRO with the knowledge, software, systems, and global footprint to make adaptive clinical trials a reality. Our full service includes the design, simulation, and execution of adaptive clinical trials that can be effectively applied in these studies.
Our proprietary software ADDPLAN enables design, simulation, and analysis of adaptive clinical trials with ease and enables faster decision making at critical points during trial execution.
ICON's Vaccine Service Offerings
Our extensive services include:
- Project and study management
- Expert consultation and operational delivery Phase I-IV
- Lifecycle management and outcomes research protocol development
- Regulatory consultancy with phase specific quality systems
- Medical Affairs and monitoring
- Data management
- Vaccine Government Experience (DMID / TRI, NIAID / BARDA / NIH) - 9 years as monitoring contractor safety oversight committee coordinator on 70+ trials for NIH/ DMID globally including developing countries
- Patient recruitment
Investigator Site Networks
Our investigator database includes over 3,800 vaccine experienced independent and network sites across the world, including developing countries. We have well established relationships with the major infectious diseases site networks in the US and also work with numerous site networks in Europe, Asia Pacific, Africa and the Middle East. These relationships ensure faster response times, higher performing sites, better quality data, along with meeting enrolment expectations.
Site identification is implemented via application of PRAEVISIO, a database which validates site access to patients prior to site selection. This increases our success in enrolling the right patients in the right places.
FIRECREST, our clinical site management and e-learning platform, centralises and streamlines communications across the study. This enables transparency in communication and training to our sites and project teams.
Our technology platform, ICONIK, enables us to analyse the operational and clinical data collected during clinical development. This enables better decision making and the successful implementation of clinical trial strategies that significantly improve efficiency in clinical trials.