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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.
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Digital health : patient safety and the next frontier
Medical and wearable devices, remote in-vitro diagnostics and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.
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SDoH data analysis for proactive outcome improvement: A multilayered approach
Social determinants of health affect patients in widely variable ways, and proper, multi-layered analysis is required to gain actionable insight into patient healthcare consumption and behaviour to optimise brand strategy and deliver better solutions and services to patients.
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How AI could transform literature surveillance for pharmacovigilance
In pharmacovigilance AI could be used to detect adverse events sooner, offering benefits for patients and researchers.
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SDoH data for efficient, patient-centred clinical trials
The social determinants of health (SDoH) are a key component of understanding and delivering better outcomes for patients.
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Insights from PHUSE US Connect 2024
ICON recently attended the PHUSE US Connect Conference, which took place from February 25th to 28th in Bethesda, Maryland, participating in exhibitions, unique presentations and interactive discussions on key topics. ICON’s experts shared their insights in multiple presentations within the statistical programming sphere.
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How pharma can use social determinant of health to address health equity
The majority of our disease risk is social and environmental, not genetic, meaning the social determinants of health are a key piece of the puzzle. Effectively leveraging SDoH data can help close the gap in health equity and reveal new insights to guide pharma brand growth.
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How data intelligence tools are enhancing signal detection methods
Advancements in intelligence tools such as ICON’s Signet help overcome challenges with data volume, complexity and completeness to accurately and rapidly detect safety signals to ensure patient safety throughout the drug’s lifecycle.
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Digital therapeutics considerations for CNS
This blog explores DTx in CNS clinical trials: regulatory landscape, data management, endpoints, payer coverage, and future trends.
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Keeping up to date with the latest regulatory developments for decentralised clinical trials
This blog examines the crucial topic of regulating the use of DCTs, exploring what’s in place now and what sponsors need to consider as these methods continue to gain traction.
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Realising the benefits of bringing decentralised cardiovascular trials to patients
This blog reflects on the success of the first fully decentralised cardiovascular trial during the COVID-19 pandemic and highlights key elements for future trials.
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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.
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Data capture: The benefits and evolution of eCOA
As the demand for improving patient safety in clinical trials continues to rise, so will the use of technology as a way to better capture data and enhance clinical outcome assessments (COAs).
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Harnessing digital health to advance traumatic brain injury clinical trials
Advances in wearable technology have provided an effective tool to monitor outcomes and facilitate the delivery of interventions in patients across indications, especially those in need of rehabilitation interventions.
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Dirty data: How to manage data from wearables in clinical trials
How to manage data from wearables in clinical trials — from overcoming regulatory issues to handling challenges associated with dirty data.
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Mapping digital health transformation: from digital endpoints to device selection
At ICON, our framework maps the transition from device selection to digital endpoint validation, leading to a better data management and risk mitigation.
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Wearables across phases: How to best incorporate digital endpoints at every stage of clinical research
Once implemented properly, digital endpoints have the potential to enhance any trial, whether observational or interventional, or early or late phase.
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Remote management: the new normal in a post-COVID world
As procedures typically carried out on-site continue to be managed remotely, sponsors will need to implement a remote clinical trial management strategy to mitigate further roadblocks that may arise and keep clinical trials moving forward.
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Best practices for designing digital endpoints for COVID-19 clinical trials amid uncertainty
Utilising data from sensors, wearables and other digital health technologies can provide critical information on COVID- 19 related symptoms and identify digital biomarkers in real- time.
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
- mHealth wearables
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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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Decoding AI in software as a medical device (SaMD)
- Software as a medical device (SaMD)
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Clinical strategies to optimise SaMD for treating mental health
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Patient Centricity
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Accelerating clinical development through DHTs
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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
- Representation 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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Prioritising patient-centred research for regulatory approval
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Accelerating clinical development through DHTs
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Regulatory Intelligence
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Accelerating access
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Meeting requirements for Joint Clinical Assessments
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Navigating the regulatory landscape in the US and Japan:
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Preparing for ICH GCP E6(R3) implementation
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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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Exploring FDA guidance for modern Data Monitoring Committees
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Streamlining dossier preparation
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Accelerating access
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Therapeutics insights
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Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
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Central Nervous System
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A mind for digital therapeutics
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Challenges and opportunities in traumatic brain injury clinical trials
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Challenges and opportunities in Parkinson’s Disease clinical trials
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Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
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Key Considerations in Chronic Pain Clinical Trials
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ICON survey report: CNS therapeutic development
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A mind for digital therapeutics
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Glycomics
- Infectious Diseases
- NASH
- Obesity
- 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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Endocrine and Metabolic Disorders
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Transforming Trials
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Accelerating biotech innovation from discovery to commercialisation
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Demystifying the Systematic Literature Reviews
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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From bottlenecks to breakthroughs
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Linguistic validation of Clinical Outcomes Assessments
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More than monitoring
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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
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Blended solutions insights
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Clinical trials in Japan: An enterprise growth and management strategy
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How investments in supply of CRAs is better than competing with the demand for CRAs
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The evolution of FSP: not just for large pharma
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Embracing a blended operating model
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Observations in outsourcing: Survey results show a blended future
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Clinical trials in Japan: An enterprise growth and management strategy
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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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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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Integrating openness and precision for competitive advantage
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Strategies for commercialising oncology treatments for young adults
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