BioPharma companies and Medical Device manufacturers face growing operational, regulatory and economic challenges. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.
Technologies that accelerate and improve clinical trials.
Patients are now better informed on clinical options than they ever have been.
Regulatory experts partnering with you.
Thought leadership from ICON's global team of therapeutic experts.
The traditional clinical development model needs to change.
The traditional healthcare delivery model is changing.
In this whitepaper, we consider the benefits of adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.
A successful MAT application is a very complex and cross-functional activity, involving many steps that require insightful planning and execution. Read the whitepaper for best practices and clear guidance on transferring medical products.
The patient pool for rare disease clinical trials is often small and widely dispersed. Likewise, clinical sites with specialised experience are rare. These issues can be mitigated by enrolling patients who are not residents of the country where the trial is being conducted.
This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.
In this paper we will provide an overview of the Pharmacovigilance System Master File (PSMF) and discuss how it has evolved over the last ten years.
ICON’s experts present best practices for sponsors and patient advocacy organisations interested in working together to design and implement patient registries.
How industry can accelerate readiness through collaboration with patient organisations.
The cell and gene therapy (CGT) market is rapidly transitioning from ultra-niche cutting-edge science to approved and available therapies that can address previously intractable and often devastating diseases.
Scientific posters are in need of a design overhaul. Poster sessions are a valuable opportunity to communicate research with a large audience.
How all sponsors can benefit from a synchronized outsourcing strategy.
Practical strategies for rare disease natural history studies, patient identification, recruitment and retention.
A unique approach to evolve the traditional local clinical development model in Japan, while lowering costs, improving productivity, and potentially accelerating drug approval timelines.
Learn about best practices that can be implemented during the process of creating an initial PBRER, with advice regarding international product birth dates, safety systems, patient exposure and support, and submission portals.
Learn how our Regulatory Affairs teams can help sponsors navigate through the regulatory challenges, bridge communication with the CDE, and develop successful regulatory strategies.
Insights on the barriers to accessing under-represented subgroups, the regulatory landscape and how organisations are addressing this issue.
The value of digital health technologies in supporting drug reimbursement decisions
A step-by-step guide to creating market success.
Success factors related to conducting basket LTFU studies.
Insights on how HTA bodies would proceed, expectations could be for data packages, and how accepting they may be of data from external control arms.
What companies must consider when developing an asset and the importance of regulatory strategy.
Gather tips and checklists for making the move to decentralised clinical trials.
How clinical research can combat an ensuing global crisis.
Read our summary report for insight into how organisations responded rapidly to the developments in 2020 and how this is paving the way for continuous improvements into the future.
Early in 2021, ICON conducted a survey to compare it to one conducted in 2019 to see if the COVID-19 outbreak had changed the sentiment and increased interest in participating in clinical trials remotely.
Bringing clinical trial visits to patients in their homes decreases burden and leads to higher enrollment rates.
A robust risk analysis and assessment review should dictate the monitoring strategy and needs to be carried out for all studies.
The promise and complexity of living therapies.
From antiretroviral therapy to vaccines, where we are today and what’s next.
Results of ICON’s third annual survey.
A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.
Understanding the Bayesian and Frequentist approaches.
Current views and future outlook.
The flexibility to keep your trials on track.
From identifying biomarkers to improving clinical trial efficiency.
An analysis of formal patient involvement in the development of drugs for rare diseases.
Ensure patient safety and trial integrity during a global pandemic.
Exploring the patient dynamic from different perspectives.
An end-to-end approach to managing wearable devices through clinical development.
Find out more about estimands and how deploying this approach will improve the quality of clinical research.
Insights to maximise HTA success.
The patient perspective.
Best practices to accelerate operations while the world waits.
ICON conducted a survey through its Global Site Network to get the patient view.
In-depth interviews reveal what manufacturers can expect from US payers.
Why outsourcing pharmacovigilance make sense at an affiliate level
Discover how emerging technologies can increase clinical trial efficiency
Harnessing the power of digital technologies.
Perspectives from senior pharma executives
Engage assay experts with unparalleled experience and expertise
Understanding the challenges for formulary decision makers and manufacturer
Determine the right design, assessments and endpoints in your pain study
Develop the right business strategy to successfully navigate MDR/IVDR
primary research evaluating ICER’s influence over payers and manufactures
Increasing efficiency through automation
Develop an integrated, patient centric approach to harnessing Digital Health technologies
Get the insights you need for successful biosimilar commercialisation
Global Investigator Payments Solutions
ICON’s monthly Regulatory Intelligence Newsletter
Legacy Data Conversion
Remote monitoring and leveraging wearable devices and sensors in clinical trials.
An adaptive design clinical trial can help to create a stronger value proposition for your medical device by reducing development costs and accelerating time-to-market.