ICON Insights
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.
Thought leadership
- Digital DisruptionTechnologies that accelerate and improve clinical trials.
- Patient CentricityPatients are now better informed on clinical options than they ever have been.
- Regulatory intelligenceRegulatory experts partnering with you.
- Therapeutics insightsThought leadership from ICON's global team of therapeutic experts.
- Transforming TrialsThe traditional clinical development model needs to change.
- Value Based DevelopmentThe traditional healthcare delivery model is changing.
Digital Disruption
Technologies that accelerate and improve clinical trials.
Patient Centricity
Patients are now better informed on clinical options than they ever have been.
Regulatory intelligence
Regulatory experts partnering with you.
Therapeutics insights
Thought leadership from ICON's global team of therapeutic experts.
Transforming Trials
The traditional clinical development model needs to change.
Value Based Development
The traditional healthcare delivery model is changing.
Insight topics
Pharmacovigilance Affiliate Model
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.
Transfer of marketing authorisation
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.
Cross-border enrollment of rare disease patients
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.
Sponsor and CRO pharmacovigilance and safety alliances
This whitepaper outlines the best practices and model options for ensuring success when outsourcing pharmacovigilance and patient safety services.
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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.
The key to remarkable rare disease registries
ICON’s experts present best practices for sponsors and patient advocacy organisations interested in working together to design and implement patient registries.
The RACE for Children Act
How industry can accelerate readiness through collaboration with patient organisations.
Mainstreaming Cell & Gene Therapies
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.
Best practices to increase engagement with medical and scientific poster content
Scientific posters are in need of a design overhaul. Poster sessions are a valuable opportunity to communicate research with a large audience.
The evolution of FSP: not just for large pharma
How all sponsors can benefit from a synchronized outsourcing strategy.
Natural history studies to improve drug development in rare diseases
Practical strategies for rare disease natural history studies, patient identification, recruitment and retention.
Clinical trials in Japan: An enterprise growth and management strategy
A unique approach to evolve the traditional local clinical development model in Japan, while lowering costs, improving productivity, and potentially accelerating drug approval timelines.
Understanding the Periodic Benefit-Risk Evaluation Report
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.
Spotlight on regulatory reforms in China
Learn how our Regulatory Affairs teams can help sponsors navigate through the regulatory challenges, bridge communication with the CDE, and develop successful regulatory strategies.
Diversity and inclusion in clinical trials
Insights on the barriers to accessing under-represented subgroups, the regulatory landscape and how organisations are addressing this issue.
Closing the evidence gap
The value of digital health technologies in supporting drug reimbursement decisions
Medical communications in early phase product development
A step-by-step guide to creating market success.
Long-term follow-up studies of cell and gene therapies
Success factors related to conducting basket LTFU studies.
Ensuring scientific rigor in external control arms
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.
Early engagement and regulatory considerations for biotech
What companies must consider when developing an asset and the importance of regulatory strategy.
Practical considerations in transitioning to hybrid or decentralised clinical trials
Gather tips and checklists for making the move to decentralised clinical trials.
Antimicrobial resistance
How clinical research can combat an ensuing global crisis.
Biopharma perspective: The promise of decentralised models and diversity in clinical trials
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.
Patient insight - decentralised & hybrid clinical trials
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.
In-home services in decentralised clinical trials
Bringing clinical trial visits to patients in their homes decreases burden and leads to higher enrollment rates.
Risk Based Quality Management
A robust risk analysis and assessment review should dictate the monitoring strategy and needs to be carried out for all studies.
Cell and gene therapy clinical trials
The promise and complexity of living therapies.
The evolution of HIV treatments
From antiretroviral therapy to vaccines, where we are today and what’s next.
ICER’s impact on payer decision making
Results of ICON’s third annual survey.
The IVDR journey
A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.
Leveraging historical data for use in rare disease trials
Understanding the Bayesian and Frequentist approaches.
US payers’ reliance on patient-reported outcomes in coverage decisions
Current views and future outlook.
Agile clinical monitoring
The flexibility to keep your trials on track.
Challenges and opportunities in traumatic brain injury clinical trials
From identifying biomarkers to improving clinical trial efficiency.
Patient centricity in orphan drug development
An analysis of formal patient involvement in the development of drugs for rare diseases.
Mitigating the impact of COVID-19 on cardiovascular trials
Ensure patient safety and trial integrity during a global pandemic.
Patient Centricity
Exploring the patient dynamic from different perspectives.
Advancing digital endpoints
An end-to-end approach to managing wearable devices through clinical development.
Biostatistics - Bringing clarity and focus to the research question: the role of estimands
Find out more about estimands and how deploying this approach will improve the quality of clinical research.
COVID-19: Navigating global market access requirements
Insights to maximise HTA success.
Patient Voice Survey - Decentralised and hybrid trials
The patient perspective.
Pandemic respiratory vaccine clinical trials
Best practices to accelerate operations while the world waits.
Decentralised and hybrid trials
ICON conducted a survey through its Global Site Network to get the patient view.
Payers’ perspectives on digital therapeutics
In-depth interviews reveal what manufacturers can expect from US payers.
Outsourced pharmacovigilance affiliate solution
Why outsourcing pharmacovigilance make sense at an affiliate level
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
Discover how emerging technologies can increase clinical trial efficiency
How Digital Technologies will Transform R&D Productivity
Harnessing the power of digital technologies.
Increasing Complexity and Declining ROI in Drug Development
Perspectives from senior pharma executives
Flow Cytometry for Driving Trials Forward
Engage assay experts with unparalleled experience and expertise
Impact of Artificial Intelligence on Outcomes Based Contracting
Understanding the challenges for formulary decision makers and manufacturer
Key Considerations in Chronic Pain Clinical Trials
Determine the right design, assessments and endpoints in your pain study
MDR/IVDR brings higher costs and bottlenecks
Develop the right business strategy to successfully navigate MDR/IVDR
The Role of ICER as an Independent HTA Organisation
primary research evaluating ICER’s influence over payers and manufactures
Drug Safety Reporting
Increasing efficiency through automation
Personalising Digital Health
Develop an integrated, patient centric approach to harnessing Digital Health technologies
Making Sense of the Biosimilars Market
Get the insights you need for successful biosimilar commercialisation
Investigator Payments
Global Investigator Payments Solutions
Regulatory Intelligence Newsletter
ICON’s monthly Regulatory Intelligence Newsletter
CDISC Data Standardisation
Legacy Data Conversion
Wearables
Remote monitoring and leveraging wearable devices and sensors in clinical trials.
Adaptive Design: The Faster Path to Market
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.