Keeping your clinical trial on track in an evolving environment.
ICON's CEO Steve Cutler on our current organisational response to the evolving situation with COVID-19.
ICON has a range of existing services that will support you to keep your clinical trial on track including Direct to patient support, In-home & Alternative Site Clinical Services, remote monitoring and FIRECREST solutions to provide site and patient training remotely.
ICON has adopted numerous measures to protect the welfare of patients, to protect the safety of our employees and to ensure the continuity of your research programmes (see Letter from ICON CEO). ICON study teams are continuing to review studies and are contacting sites and regulatory agencies to determine the impact of COVID-19 on study timelines. Where there are instances of predicted delays, ICON study teams are working with customer teams to develop study-specific plans to minimize the risk to study timelines. ICON has a range of services and tools which can be adopted to mitigate disruption to trial timelines:
The FDA guidance published March 2020 advised sponsors to evaluate alternative methods of patient safety assessments that can be deployed while travel to sites may be curtailed.
Deploying healthcare professionals that are trained to carry out a wide range of services and tests in the patients home will reduce patient anxiety, the risk of infection and also help you to reduce the risk of patient drop-out in your study.
Through it's acquisition of Symphony Clinical Research, ICON is now the leading global provider of specialised at-home patient clinical services with geographical coverage in 57 countries across the globe.
Download our factsheet, which includes considerations for operationalising these services and the support we can provide to manage potential risks.Download factsheet
Built on our global clinical outcomes expertise, real world evidence experience and clinical cross-cultural language services expertise, our Direct to Patient Contact solutions support patients or their caregivers in studies and disease management programs. We offer multi-faceted contact methods including email, SMS, phone, letter and in-app alerts to:
The need to restrict travel and protect healthcare professionals has understandably resulted in the cancellation of investigator meetings.
FIRECREST digital solutions provide the option to pre-record meeting content and be able to maintain reporting for compliance.
- Multiple content options including pre-recorded videos supplied by study team or multimedia training materials developed by our learning specialists
- Content converted into customised format for on-line delivery
- User-based training control management
- Full investigator meeting document records and managementDownload factsheet
Our Site Management Associate (SMA) model is designed specifically for managing late phase studies, in multiple languages and cultures, to provide continuous site support throughout the world. This focused, one-on-one approach is designed to improve data collection, ensure high quality data, and enhance site and patient engagement, while significantly reducing late-phase study costs.Learn more
We have conducted more than 246 vaccine studies globally, including over 40 studies in respiratory viruses, within the past five years alone. In February ICON quickly mobilized its Vaccines, Infectious Diseases and Government and Public Health Solutions resources to assist both government and commercial clients in addressing the COVID-19 global threat and is already providing clinical monitoring and safety oversight on a number of new COVID-19 trials. ICON has participated in five studies during infectious disease outbreaks within the past 10 years, including two for H1N1 during a H1N1 pandemic and three for H7N9.
Related media article: ICON execs discuss developments in vaccine research efforts and key challenges of delivering a coronavirus vaccine (PDF)
Related blog: COVID-19 vaccine trialsDownload factsheet
ICON regulatory consultants work to provide rigorous, integrated strategic and operational guidance on regulatory updates to support customers' clinical development programmes. In particular, they can help navigate the frequent updates and developments in the current COVID-19 pandemic including issues such as variations in regulatory guidelines on clinical trial conduct, pharmaceutical export restrictions, expanded access, including compassionate use access, for COVID-19 related compounds in clinical trials.
Download: the latest issue of our Regulatory Intelligence Newsletter (PDF), which examines COVID-19 updates from regulatory and health authorities around the world.
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ICON has conducted more than 67 respiratory studies globally within the past five years with considerable experience in supporting trials of respiratory disease, infectious disease affecting respiratory function, and supporting investigational treatments in the biotech, pharmaceutical, medical device and diagnostic industries. Additionally, our Medical Device & Diagnostics division has assisted with studies to aid in the diagnosis of respiratory conditions or with devices utilised to administer drugs in support of respiratory conditions.
As the COVID-19 pandemic evolves effecting the regulatory and clinical and landscape, ICON experts are available to support all aspects of your respiratory programme requirements.Learn more
The ICON Coronavirus Observatory applies powerful AI analysis and data visualisation to COVID-19 clinical trials news and social media, providing updates on the latest clinical trials, with insights into trending topics driving Coronavirus reporting. The Coronavirus Observatory also breaks down the global impact of the virus, looks at trending topics per country, and highlights important perspectives from the key organisations, including non-governmental organisations, public health authorities and the medical science community.
Download: Quick guide to the ICON Coronavirus Observatory (PDF)Visit Coronavirus Observatory