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ICON plc
  • Services

    Services

    Our services 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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    Services
    Clinical Research ServicesCommercial PositioningConsultingEarly PhaseStrategic SolutionsLaboratoriesLanguage ServicesMedical ImagingReal World IntelligenceSite & Patient Solutions
    Clinical trials during COVID-19.
    COVID-19 clinical operations

    Clinical trials during COVID-19.

    Bringing the clinical trial to the patient with innovation and in-home solutions.
    Decentralised & hybrid clinical solutions

    Bringing the clinical trial to the patient with innovation and in-home solutions.

  • Sectors

    Sectors

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

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    Sectors
    BiosimilarsBiotechGovernment & Public Health SolutionsMedical DevicePharmaceuticals
    A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.
    The IVDR journey

    A roadmap to meet 2022 deadlines, while navigating pandemic disruptions.

    Developing transformative therapies requires a flexible approach.
    Biotech

    Developing transformative therapies requires a flexible approach.

  • 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.

  • Innovation

    Innovation

    We develop integrated technologies to significantly enhance the efficiency and productivity of clients’ drug and device development programs.

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    Innovation
    FIRECRESTICON Digital PlatformSafety Reporting SolutionOne SearchEvidence PlatformFLEX ADVANTAGEMedical Imaging TechnologyNONMEM ICONIKPDx-POPPubsHubSIMSICOMaster for eTMF
    With travel restrictions due to COVID-19, FIRECREST helps deliver and manage remote training for investigators.
    FIRECREST

    With travel restrictions due to COVID-19, FIRECREST helps deliver and manage remote training for investigators.

    Harmonising data and services for more integrated decentralised clinical trials.
    ICON Digital Platform

    Harmonising data and services for more integrated decentralised clinical trials.

  • 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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    Insights
    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 & hybrid 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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    News & Events
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    Webinar: Regulatory considerations for technology in decentralised clinical trials

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    Watch the webinar
    Webinar: Social media data - Opportunities and insights for clinical research

    Watch the webinar

  • 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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    About ICON
    Company historyICON in Asia PacificICON in Latin AmericaLeadershipQuality
    ICON is committed to making a positive impact on our people, environment and our community.
    Environmental, Social & Governance

    ICON is committed to making a positive impact on our people, environment and our community.

    Partners making a difference.
    ICON and You

    Partners making a difference.

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  1. Home
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  3. Blog

Blog

  • 03 February 2023

    My patient story - Chelsea Mason

    ICON's Chelsea Mason shares her personal experiences with cancer.

  • 03 February 2023

    My patient story - Margaritte De Falco

    ICON's Margaritte De Falco shares her personal experience with ovarian cancer.

  • 03 February 2023

    My patient story - Claudia Egremont-Lee

    ICON's Claudia Egremont-Lee shares her personal experience with breast cancer.

  • 18 January 2023

    The importance of developing rTPP to build biotech asset value

    Discover how Biotechs can build value into their asset by developing a reimbursable Target Product Profile (rTPP).

  • 13 January 2023

    The impact of real world evidence on drug marketing approval and reimbursement

    Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.

  • 06 January 2023

    Redefining sourcing model terminology

    This blog explores the new framework for defining CRO sourcing models and explains its importance.

  • 20 December 2022

    Optimising biotech trial designs to stretch your cash runway

    Read this blog to learn a few key considerations to help optimise and de-risk your trial design.

  • 19 December 2022

    Crafting a competitive biotech funding pitch

    Biotechs can hone their pitch with the guidelines provided in this blog and through early engagement opportunities with strategic partners.

  • 15 December 2022

    Medical device classifications and applicable Food and Drug Administration regulations

    Medical device manufacturers should understand how their product is viewed by regulatory bodies to proceed with the appropriate regulatory pathway to market.

  • 14 December 2022

    Filling the gaps for rare and orphan diseases

    Read the blog to learn more about the benefits and challenges of Rare Disease natural history studies.

  • 06 December 2022

    Pharmacovigilance outsourcing: Tips for selecting a service provider

    Selecting a vendor requires careful exploration and planning to ensure a successful relationship between sponsor and outsourcing partner.

  • 05 December 2022

    MDR transition period and certification bottleneck

    It is of paramount importance that companies with expiring certification begin the process to remain compliant under the new MDR. Read more about identified challenges and solutions.

  • 01 December 2022

    Implementing surveillance measures to prioritise patient safety

    Patient centricity is a top priority at ICON. We use the latest technologies to detect and manage potential risks posed by medicinal products in accordance with GVP.

  • 30 November 2022

    US marketing approval of drugs and devices by sole reliance on foreign (non-US) clinical data

    Clinical research is becoming increasingly global. Sponsors may choose to conduct multinational clinical studies under a variety of scenarios at both foreign (non-US) sites and US sites.

  • 29 November 2022

    Challenges and key success factors for linguistic validation and COA translation within clinical trials

    This blog outlines challenges and key success factors in the linguistic validation process.

  • 23 November 2022

    Chemistry, manufacturing, and controls in drug development and life cycle management

    Chemistry, Manufacturing, and Controls (CMC) is the “first step” to ensuring drug quality throughout the product development lifecycle.

  • 18 November 2022

    Understanding the impact of the Clinical Trial Liaison (CTL) function

    The impact of the clinical trial liaison function (CTL) in developing and delivering optimal clinical trials.

  • 17 November 2022

    Empowering children with education through clinical trials

    In support of World Children’s Day 2022, this blog shares strategies to empower children every day through education, specifically in clinical trials.

  • 17 November 2022

    A rare partnership: collaborating with patient advocacy organisations for rare disease registries

    Rare disease registries: practical ways to build trust and collaboration with patient advocacy groups.

  • 10 November 2022

    Keep eCOA off the critical path of clinical trial startup

    In today’s patient-driven and competitive drug development landscape, healthcare organizations cannot succeed without active patient insight through COAs.

In this section
In this section
  • Digital Disruption
    • AI and clinical trials
      • Impact of AI on Outcomes Based Contracting
    • Clinical trial data anonymisation and data sharing
    • 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
      • 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
    • Current overview of data sharing within clinical trial transparency
    • EU Regulations
      • 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
    • Keeping the end in mind: key considerations for creating plain language summaries
    • 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
      • Cell and Gene ebook
      • Long-term follow-up studies of cell and gene therapies
      • Mainstreaming Cell & Gene Therapies
    • Central Nervous System
      • 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
      • HIV
    • NASH
      • The voice of NASH investigators
    • Oncology
    • 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 & hybrid 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
    • Functional model insights
      • 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
    • 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
    • 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
  • Blog
  • Videos
  • Webinar Channel
  • Diversity and inclusion in clinical trials
    • Diversity and inclusion in clinical trials whitepaper
  • Decentralised & hybrid 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

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