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The race to develop combination vaccines – and the importance of indirect effects
A development race is currently underway in the field of combination vaccines, with a number of influential pharmaceutical and biotech companies pursuing combination vaccines targeting influenza and COVID-19.
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Unlocking quality in machine translation: The impact of ISO 18587 certification on clinical research
ISO 18587 certification helps ensure consistency and quality in the post-editing process, fostering trust and confidence in machine-translated content across various industries and applications.
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Tested, tried and true: Why digital biomarkers are the AI & ML strategy pharma should prioritise
Rather than chasing generative AI, pharma executives can focus their AI and machine learning (ML) strategies for drug development on investing in and deploying connected sensors to reduce costs and improve patient outcomes.
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Outcome measures: Driving precision health strategies forward
ICON has been speaking, collaborating, and building with top pharma throughout the year to help them develop better drugs, faster, for patients. Here are a few observations from this year.
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Digital endpoints widely adopted in pharmaceutical and biotech-sponsored clinical trials
Over 130 pharma and biotech organizations have relied on AI-powered digital biomarkers and sensor-derived clinical outcome assessments (COAs) to capture patient-centered endpoints.
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The impact of AI on the evolution of machine translation
From its nascent stages to the sophisticated systems we employ today, machine translation has become an indispensable efficiency generating tool.
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Streamlining early phase clinical trial submissions under the EU CTR
The EU Clinical Trials Regulation (CTR) represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe.
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Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay
ICON's new RNA-based NGS assay improves CML monitoring, offering higher sensitivity and specificity, including for the identification of typical and atypical BCR::ABL1 transcript types and the detection of TKI resistant mutation.
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Insights from PSI 2024: Advancements in digital health technology
ICON’s statisticians share insights from the PSI’s 2024 conference where they presented on advancements in digital health technology and decision making.
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Defining the differences when regulating medical devices, medicinal and combination products
A basic guide to the complex regulations governing clinical trials which involve medical devices and medicinal products.
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Pushing boundaries in idiopathic pulmonary fibrosis clinical research
The landscape of IPF research is evolving and early-stage biopharmaceutical teams need a new roadmap to success. We offer strategies to meet the challenges to develop new treatments.
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Essential components of a successful global labelling process
By incorporating these essential components, global labelling processes increase their fundamental impact on delivering an efficient drug development program.
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Innovative approaches to ensuring participant safety in early phase clinical research
Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. With innovative tools and unique collaboration models, ICON is driving more proactive participant safety measures to effectively mitigate risks.
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How human-enabled AI is creating a new map for navigating site selection
Discover how AI transforms site selection in clinical research by leveraging data and human expertise through an ecosystem approach to optimise site ranking, patient enrolment, and study timelines.
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Navigating shifting paradigms in dose optimisation and dose selection for oncology therapeutics
The maximum tolerable dose (MTD) is increasingly seen as suboptimal for emerging oncology therapies, which lack chemotherapy’s generalised cytotoxic effects. More contemporary dose-selection designs can now identify the lowest dose of an oncology therapy with the highest rate of efficacy that is tolerable for patients. Learn more.
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Innovations contributing to the reemergence of antibody drug conjugates
ADC candidates that address the limitations of their first-generation predecessors are receiving approvals, and a new wave of ADCs are in clinical development. Read the blog to explore the innovations contributing to the re-emergence of ADCs.
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Navigating oncology development decisions for long-term success
Read the blog to learn how to navigate key challenges in oncology and the important decision points including early clinical development, robust registrational strategy and late-stage development.
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Leveraging healthcare intelligence to increase diversity of oncology clinical trials
New regulatory requirements for diversity require sponsors to submit a diversity action plan alongside key trial documents to the FDA. Read the blog to learn how healthcare intelligence can be leveraged to increase diversity in oncology clinical trials.
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Veeva R&D and Quality Summit 2024
A conference on research, development and quality shows that collaboration is crucial to advancing life sciences. Three ICON clinical data scientists share what they learned.
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The rise and role of AI in medical imaging
Discover how AI is revolutionising medical imaging and clinical trials, enhancing efficiency, accuracy, and patient outcomes through innovative applications in oncology, cardiology and more.
In this section
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Digital Disruption
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Clinical strategies to optimise SaMD for treating mental health
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Digital Disruption whitepaper
- AI and clinical trials
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Regulatory Intelligence Newsletter
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
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Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
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Respiratory
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Optimising biotech funding
- Adaptive clinical trials
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
- Blended solutions insights
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
- Partnership insights
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Ensuring scientific rigor in external control arms
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Health technology assessment
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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