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Cross-border initiative to empower rare disease researchers
ICON joins new EU initiative to boost cross-border collaboration.
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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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Complexities of running clinical trials in retinal disorders and ways to overcome them
In this blog, we will explore the complexities of running clinical trials in retinal disorders and discuss ways to overcome these challenges based on our experiences from running multiple global retina studies in various indications.
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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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Diabesity: Overlapping pathophysiology informs multi-indication treatment
As recognition of the overlap between obesity and diabetes has grown, so have efforts to develop treatments that can treat the two conditions in tandem.
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Site Training for Clinical Trial Success
Training site staff on clinical trial protocols takes time and money, and poor training modules can lead to low compliance or staff that is technically trained, but have missed the learning objectives. Effective training using rich and varied content, leveraging highly engaging methodology and comprehension checks will provide learners with confidence and retention long after the training is completed. Learn more about what you need to reduce risk, increase compliance and enhance quality with a comprehensive training solution.
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Beyond awareness: Driving progress on the Rare Disease journey
ICON employees share their experience with Rare Diseases.
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Rare disease trials require effective participation support strategies to succeed
ICON is leading the way in rare disease clinical research having supported 778 rare disease clinical trials in the past five years. Every day, thousands of colleagues at ICON work tirelessly to support the success of rare disease clinical research – because patients can’t wait.
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Strategies for de-risking rare disease programmes during research and development
Difficulties in research and development for rare disease therapeutics have been compounded by a historically challenging market for biotechs. ICON experts share how biotechs can maximise funding for rare disease therapeutic development in our blog.
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Insights from the 2024 ISCR Annual Conference: India’s evolving clinical research arena
ICON participated in the 17th annual Indian Society for Clinical Research (ISCR) conference on the 1-3 February in Hyderabad, India. ICON experts shared insights on topics of special interest including clinical data management and biostatistics and statistical programming, among others.
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Ensuring safety and compliance: The essentials of outsourcing pharmacovigilance
In this blog, we delve into the rationale behind outsourcing pharmacovigilance activities at the affiliate level and explore the essential requirements for appointing local persons for pharmacovigilance (LPPVs).
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Looking forward: The most significant 2024 US healthcare trends - Part 5 of 5
When discussing the 5 biggest challenges that await the healthcare industry in 2024, US politics is a key issue. America is clearly divided on many issues, including those involving government spending, healthcare reimbursements, and treatment coverage issues.
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Looking forward: The most significant 2024 US healthcare trends—Part 4 of 5
Given that some of the overall physical- and mental-health indicators show negative progress even while healthcare costs are rising, it begs the question: What is the reason for the backslide?
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Looking forward: The most significant 2024 US healthcare trends—Part 3 of 5
Physical- and mental-health measure declines are 2 factors likely to impact the healthcare industry as they move forward in 2024 and beyond. Not surprisingly, concerns over rising healthcare costs and how to best control them continue to dominate in significance.
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Looking forward: The most significant 2024 US healthcare trends - Part 2 of 5
In addition to physical health indicators, mental health declines also serve as a measure of the serious health concerns to the healthcare industry in the United States. These changes likely impact drug manufacturers directly and indirectly through market needs, opportunities, and resource allocations related to the development and marketing of both existing and prospective treatments.
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Looking forward: The most significant 2024 US healthcare trends - Part 1 of 5
2024 may well be the most challenging year yet for the US healthcare industry. Our research reveals 5 overarching trends likely to have the strongest impact on the industry and improving the health of Americans for the months and years ahead.
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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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Trialling abroad: How sponsors, ethics committees and regulators can improve patient outcomes in cross-border trials
Patients’ need for novel investigational treatments for life-impacting diseases in the absence of available treatment options drives an ongoing debate on how sponsors, ethics committees and regulatory bodies can work together to overcome both logistical and regulatory barriers.
In this section
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Digital Disruption
- 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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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
- 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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