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Advancing pharmacovigilance in a changing landscape: 2024 World Drug Safety Congress
With over 1,500 registered attendees, the 2024 World Drug Safety Congress brought together pharmacovigilance experts to discuss the challenges and solutions in their profession. ICON experts who were there reflect on the topics discussed and look at the emerging trends.
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Celebrating World Children’s Day
To mark World Children's Day we reflect on ICON’s commitment to increase pediatric healthcare access and inclusion by supporting pediatric clinical trials.
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Preparing for EMA policy 0070
Clinical trial data must be anonymised to protect patient privacy and business information, yet transparent enough to be useful for other researchers.
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Data Transparency: Variances in patient and claims counts explained
This blog explains how Symphony Health’s commitment to data transparency ensures clients can confidently interpret and utilise their refreshed datasets.
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Investigating multi-indication drug targets
This blog will explore some of the multi-indication drug targets that have already been developed in multiple applications, as well as considerations for entering clinical trials, such as building evidence and trial design.
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Navigating early phase challenges for biotechs
To better understand the concerns of biotechs in early phases, ICON conducted a survey of 149 professionals representing small- and medium-sized biotech organisations from North America and Europe.
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The importance of communication in patient-centred clinical trials
How can we navigate this complex linguistic landscape while preserving the integrity of the original message and keep participants well informed?
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Obesity-related liver conditions: Understanding treatment options
Explore obesity’s role in liver disease progression and the value of different treatment options providing renewed hope to patients.
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Designing clinical trials for a complex disease: Pediatric obesity
Pediatric obesity is a complex disease with multiple factors for sponsors to consider when designing and executing treatment trials.
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The importance of a robust clinical outcome assessment strategy in your clinical trial
At ICON, we understand the nuances involved in creating a COA strategy that not only meets regulatory standards but also resonates with patients and stakeholders alike.
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How an eCOA library can reduce your study start up timelines
Learn about the benefits of developing an eCOA library and how a strong eCOA strategy can help reduce screenshot review step by five weeks.
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A dynamic market: Trends transforming the future of obesity drug development
Learn about the future of obesity drug development and explore how GLP-1 drugs and multi-indication therapies are transforming treatment.
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Submission strategies for combined studies in the EU
In this article we look at how an oncology study sponsor managed their submission process which spanned more than 30 countries, many in the EU.
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Maximising clinical trial success with integrated language services
Translation management is a critical component in global clinical trials - accurate and culturally appropriate communication is non-negotiable. Learn the importance of integrated language services in clinical research.
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The benefits of going big: Why small biotechs need large CRO partners
Small biotech companies can gain significant benefits by partnering with a big CRO – if it’s the right fit. We outline some of the benefits of strategic partnerships for cash-constrained biotech.
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Accelerating ATMP and CGT: The importance of Regulatory CMC expertise in efficient biologics development
Discover how dedicated Regulatory CMC expertise benefits biologics development, ensuring compliance and efficiency, especially for innovative therapies like ATMPs and CGTs.
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Why using COAs and DHTs together is the future of clinical research
Though both COAs and DHTs are tools used to evaluate a treatment’s impact, they often exist in separate spheres, rarely integrated. We argue that combining these two approaches in the same study can help researchers gather better data and improve the likelihood of regulatory approval.
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Enhancing diversity in clinical trials
To fully assess the efficacy and safety of a therapeutic indication, clinical trials must evaluate populations that are representative of the treatment population, as different people may experience the same disease differently.
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Unlocking the value of transparent healthcare data
In this blog, we'll explore how transparency in healthcare data can unlock its full potential. Discover why transparency matters and how Symphony Health’s approach ensures you get the most accurate, actionable insights.
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Digital health: Why evaluating human factors is essential
With the rapidly evolving technology, digital health is transforming healthcare, emerging as a promising solution to reduce rising healthcare costs and improve patient care.
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: Surveying the industry's evolving landscape
- 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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