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ICON plc
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    Our solutions span the entire lifecycle of product development and commercialisation, and can be adapted to suit small local trials or large global programs.

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    Optimising real world data to drive effective outcomes and achieve regulatory authorisation.
    Real World Intelligence®

    Optimising real world data to drive effective outcomes and achieve regulatory authorisation.

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    ICON provides its full range of clinical, consulting and commercial services across several industry sectors.

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    Developing transformative therapies requires a flexible approach.
    Biotech

    Developing transformative therapies requires a flexible approach.

    Partners making a difference.
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  • Therapeutics

    Therapeutics

    We have extensive experience in a broad range of therapeutic areas. Managing studies in all major geographies, we have established solid working relationships with the world’s leading investigators.

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    Therapeutics
    CardiovascularCell and Gene TherapiesCentral Nervous SystemEndocrine & Metabolic DisordersInfectious DiseasesInternal Medicine & ImmunologyMedical DeviceOncologyPaediatricsRare & Orphan DiseasesTransplant ImmunologyWomen's Health
    ICON has lead the development of 18 vaccines resulting in FDA/EMA approvals, including the world’s first approved vaccine for COVID-19.
    Vaccines

    ICON has lead the development of 18 vaccines resulting in FDA/EMA approvals, including the world’s first approved vaccine for COVID-19.

    ICON's therapeutic experts contribute regularly to industry publications and the creation of thought leadership content. Read more.
    Therapeutics insights

    ICON's therapeutic experts contribute regularly to industry publications and the creation of thought leadership content. Read more.

  • Insights

    Insights

    BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.

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    Digital Disruption Patient CentricityRegulatory IntelligenceTherapeutics insightsTransforming TrialsValue Based HealthcareBlogVideosWebinar Channel
    Establishing a platform for improvement
    Diversity and inclusion in clinical trials

    Establishing a platform for improvement

    Patient focused research for better outcomes.
    Decentralised clinical trials

    Patient focused research for better outcomes.

  • News & Events

    News & Events

    ICON regularly contributes thought leadership to industry media publications and conferences, and has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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    18 September 2023
    Webinar: Perinatal Mood Disorders

    18 September 2023

    26 September 2023
    Webinar: Financial Times - Decentralised Clinical Trials in Focus

    26 September 2023

  • About ICON

    About ICON

    Our mission is to help clients accelerate the development of drugs and devices that save lives and improve quality of life.

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    ICON CARES is our commitment to making a positive impact on our people, environment and our community.
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  1. Home
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Blog

  • 22 August 2023

    Highlights from the revised Medicare Drug Price Negotiation program guidance

    Explore revised guidance instructions related to the Medicare Price Negotiation program in this blog.

  • 21 August 2023

    CMS Medicare Part D Price Negotiations

    In this blog find more about a current list of drugs likely to be selected for negotiation, with their same-in-class competitors.

  • 16 August 2023

    The new EMA guideline expectations

    In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.

  • 27 July 2023

    Patient-centric best practices for improved diversity

    In this blog, we share best practices for a more patient-centric approach to trials as discussed in our webinar to improve accessibility, inclusion and diversity.

  • 26 July 2023

    Disease surveillance in low- and middle-income countries

    Disease surveillance and reporting is critical to public health, enabling faster and better response to infectious disease outbreaks.

  • 24 July 2023

    Best practices for KPI management in FSP partnerships

    Learn more about the best practices for KPI creation and management in this blog.

  • 21 July 2023

    Disease surveillance and innovative vaccines

    Learn about current approaches to disease surveillance and why they are important for the advancement of vaccine development in this blog.

  • 19 June 2023

    EU CTR: Practical experiences and lessons learned

    EU CTR effective January 31, 2022, introducing new age for interventional clinical trial applications in EU and EEA. Read more about the practical experiences and lessons learned.

  • 13 June 2023

    Rare diseases and orphan drugs regulatory framework in Canada

    This blog details initiatives that are being taken by the Government of Canada to promote a health care system that works for those with rare disorders.

  • 15 May 2023

    The impact of the new EU Clinical Trial Regulation on language translation

    On January 31st, 2023, the EU Clinical Trial Regulation and the Clinical Trial Information System went live and changed the European landscape for clinical trials.

  • 15 May 2023

    Biotech’s evolving relationship with CROs

    In this blog, read more on recent trends and learn why strategic outsourcing is a key opportunity.

  • 05 May 2023

    Recent trends in the biotech funding environment

    In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.

  • 24 April 2023

    Improving the experience of healthy volunteers during early phase clinical trials

    How ICON’s application of a volunteer-centric approach is improving recruitment and retention rates of healthy participants in early phase studies.

  • 21 April 2023

    Pre-emptive vaccine research to improve EID response

    This blog explores strategies for strengthening vaccine development so that the medical community is better prepared to respond to future epidemics.

  • 18 April 2023

    Use of ddPCR and qPCR assays for PK and safety monitoring in Cell & Gene Therapy clinical trials

    Immunotherapy technologies are rapidly advancing, as are the methods of ensuring their safety and reliability. ICON explores the tools used in CGT trials.

  • 13 April 2023

    From clinician visits to data analysis: the challenges and solutions in COVID vaccine pharmacovigilance

    Learn more about the challenges and solutions in assessing the long-term effects of Covid and Covid vaccines in this blog.

  • 30 March 2023

    Mary O’Reilly reflects on International Women’s Day

    In this blog, Mary O’Reilly reflects on the International Women’s Day panel and events held at ICON’s global headquarters in Dublin.

  • 23 March 2023

    How data science is changing the face of healthcare

    In this podcast, Michael Goedde shares his journey in technology and his role in building the digital platform for healthcare systems at ICON.

  • 16 March 2023

    A positive step for diversity and inclusion in clinical trials – reflections on FDORA

    Read this blog for updated recommendations and additional guidance on DCTs to ensure equitable access to cutting-edge therapeutics and clinical trials.

  • 24 February 2023

    Rare Disease Day diversity and inclusion

    This event aims to raise awareness about the diversity of individuals affected by rare diseases. Find out how virtual events can be made more accessible and inclusive.

In this section
In this section
  • Digital Disruption
    • AI and clinical trials
      • Impact of AI on Outcomes Based Contracting
      • Using AI for site ID and selection
    • Clinical trial data anonymisation and data sharing
    • Clinical Trial Tokenisation
    • Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
    • Digital disruption in biopharma
    • Disruptive Innovation
    • Remote Patient Monitoring
      • Bring Your Own Device
      • Cybersecurity
        • Addressing cybersecurity for your medical device
      • Digital Endpoints
      • Transforming Medical Device Development with mHealth
    • Personalising Digital Health
    • Real World Data
      • Harnessing technology to maximise Real World Evidence value
      • Meeting Evidentiary Needs with EHRs
      • Post-Market Surveillance for Medical Devices
  • Patient Centricity
    • Agile Clinical Monitoring
    • Capturing the voice of the patient in clinical trials
    • Charting the Managed Access Program Landscape
    • Developing Nurse-Centric Medical Communications
    • Diversity and inclusion in clinical trials
      • Diversity and inclusion in clinical trials whitepaper
    • Exploring the patient perspective from different angles
    • Patient safety and pharmacovigilance
      • A guide to safety data migrations
      • Taking safety reporting to the next level with automation
      • Outsourced Pharmacovigilance Affiliate Solution
      • The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
      • Sponsor and CRO pharmacovigilance and safety alliances
      • Understanding the Periodic Benefit-Risk Evaluation Report
    • Patient voice survey
    • Patient Voice Survey - Decentralised and Hybrid Trials
    • Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
    • Using longitudinal qualitative research to capture the patient voice
  • Regulatory Intelligence
    • An innovative approach to rare disease clinical development
    • EU Clinical Trials Regulation
      • EMA guideline on computerised systems and electronic data in clinical trials
      • EU CTR Whitepaper
    • Using innovative tools and lean writing processes to accelerate regulatory document writing
    • Current overview of data sharing within clinical trial transparency
    • EU Regulations
      • EU MDR and IVDR transition extension: What changes do you need to know about?
      • IVDR Technical File Remediation
      • MDR and IVDR are Coming - Are you Prepared?
      • MDR / IVDR Brings Higher Costs and Bottlenecks
      • Seeking parallel consultation from regulators and HTA bodies in Europe
      • The IVDR journey
    • Global Agency Meetings: A collaborative approach to drug development
    • Keeping the end in mind: key considerations for creating plain language summaries
    • Navigating orphan drug development from early phase to marketing authorisation
    • Procedural and regulatory know-how for China biotechs in the EU
    • RACE for Children Act
    • Early engagement and regulatory considerations for biotech
    • Regulatory Intelligence Newsletter
    • Requirements & strategy considerations within clinical trial transparency
    • Spotlight on regulatory reforms in China
    • Transfer of marketing authorisation
  • Therapeutics insights
    • Cardiovascular
      • Mitigating the impact of COVID-19 on cardiovascular trials
    • Cell and Gene Therapies
      • Approaching the CAR T-cell therapy horizon
      • Cell and Gene ebook
      • Long-term follow-up studies of cell and gene therapies
      • Mainstreaming Cell & Gene Therapies
    • Central Nervous System
      • A mind for digital therapeutics
      • Challenges and opportunities in traumatic brain injury clinical trials
      • Challenges and opportunities in Parkinson’s Disease clinical trials
      • Key Considerations in Chronic Pain Clinical Trials
    • Glycomics
    • Infectious Diseases
      • Antimicrobial Resistance
      • Considerations for strengthening vaccine development
      • COVID-19 vaccine trials
      • COVID-19 vaccines: Post-authorisation safety surveillance
      • HIV
      • The value of dynamic transmission models
    • NASH
      • The voice of NASH investigators
    • Oncology
    • Paediatrics
      • Paediatric Risk Assessment Map
    • Rare and orphan diseases
      • Advanced therapies for rare diseases
      • Cross-border enrollment of rare disease patients
      • Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
      • Diversity, equity and inclusion in rare disease clinical trials
      • Identify and mitigate risks to rare disease clinical programmes
      • Leveraging historical data for use in rare disease trials
      • Natural history studies to improve drug development in rare diseases
      • Patient Centricity in Orphan Drug Development
      • The key to remarkable rare disease registries
  • Transforming Trials
    • Adaptive clinical trials
      • Adaptive Design: The Faster Path to Market
    • Best practices to increase engagement with medical and scientific poster content
    • Decentralised clinical trials
      • Biopharma perspective: the promise of decentralised models and diversity in clinical trials
      • Decentralised and Hybrid clinical trials
      • Practical considerations in transitioning to hybrid or decentralised clinical trials
      • Navigating the regulatory labyrinth of technology in decentralised clinical trials
    • eCOA implementation
    • Flexible delivery models
      • Clinical trials in Japan: An enterprise growth and management strategy
      • How investments in supply of CRAs is better than competing with the demand for CRAs
      • The evolution of FSP: not just for large pharma
    • Implications of COVID-19 on statistical design and analyses of clinical studies
    • Improving pharma R&D efficiency
    • Increasing Complexity and Declining ROI in Drug Development
    • Innovation in Clinical Trial Methodologies
    • Partnership insights
      • Exploring partnership culture and its impact on outsourcing and operational strategy
    • Risk Based Quality Management
    • Supporting a top 10 pharma to transition to Veeva Vault platform
    • Transforming the R&D Model to Sustain Growth
  • Value Based Healthcare
    • US payers and PROs
    • Accelerated early clinical manufacturing
    • Cardiovascular Medical Devices
    • CMS Part D Price Negotiations: Is your drug on the list?
    • COVID-19 navigating global market access
    • Ensuring scientific rigor in external control arms
    • Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
    • Global Outcomes Benchmarking
    • Health technology assessment
    • Perspectives from US payers
    • ICER’s impact on payer decision making
    • Making Sense of the Biosimilars Market
    • Medical communications in early phase product development
    • Navigating the Challenges and Opportunities of Value Based Healthcare
    • Payer Reliance on ICER and Perceptions on Value Based Pricing
    • Payers Perspectives on Digital Therapeutics
    • Precision Medicine
    • RWE Generation Cross Sectional Studies and Medical Chart Review
    • Survey results: How to engage healthcare decision-makers
    • The affordability hurdle for gene therapies
    • The Role of ICER as an HTA Organisation
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