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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.
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Digital health: Managing cybersecurity risks
When developing a new digital health device, as well as maintaining an existing device, securing the device from cybersecurity attacks is critical.
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Navigating the impacts of the Inflation Reduction Act (IRA): Strategic considerations for pharma
Explore the Inflation Reduction Act’s key points of impact on pharmaceutical companies and considerations to strategically evolve with the coming changes.
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Medicare Part D Price Negotiations update – Widespread impact on the industry
The Inflation Reduction Act (IRA) and resulting Medicare Part D price negotiations promise widespread impact on the industry. For the first time in history, the government is empowered to negotiate drug pricing directly with manufacturers.
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Utilising connected sensors to power diverse and equitable clinical trials
Our publication in Nature npj Digital Medicine outlines current evidence and a solution framework for diversity in research using digital health technologies.
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Outcome Measures: Driving forward patient-centered clinical trials
ICON’s Outcome Measures service aims to drive forward patient-centered treatments while also helping sponsors increase the likelihood of regulatory approval.
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Enabling a new way to select fit-for-purpose COAs to simplify clinical protocols
While digital health technologies are one piece of the clinical protocol puzzle, holistic protocol design requires more breadth.
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Enhancing diversity in clinical trials with AI and human expertise
Explore how AI-enabled insights and data-driven site selection can play a key part in a multifaceted approach to diversity in clinical trials and benefit equity in healthcare by extension.
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The rise of precision outcome measures
Precision outcome measures are the means by which to evaluate a meaningful change on the exact outcome of interest, regardless of tool or instrument.
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Understanding China's 2024 NRDL: Key changes and their impact
This blog provides an overview of the NRDL’s history, highlights the key changes for 2024, and discusses the potential impact on both local and international pharmaceutical industries.
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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 & machine learning (ML) strategies for drug development on investing in and deploying connected sensors to reduce costs & 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.
In this section
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Digital Disruption
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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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Digital Disruption whitepaper
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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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