Artificial intelligence is transforming how life sciences teams plan, execute, and scale commercial strategy—but the true differentiator isn’t the algorithm. It’s the data foundation behind it. In our latest blog, we ex...
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Filter blogs by either clicking within the ‘Category’ drop-down list, or begin typing which will automatically match to the nearest available category. Note - not all categories will display results if selecting a particular year.
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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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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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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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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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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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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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Best practices for KPI management in FSP partnerships
Learn more about the best practices for KPI creation and management in this blog.
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A positive step for diversity and inclusion in clinical trials – reflections on FDORA
Read this blog for updated recommendations and additional guidance on DCTs to ensure equitable access to cutting-edge therapeutics and clinical trials.
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Redefining sourcing model terminology
This blog explores the new framework for defining CRO sourcing models and explains its importance.
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Challenges and key success factors for linguistic validation and COA translation within clinical trials
This blog outlines challenges and key success factors in the linguistic validation process.
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Managed service providers
Managed Service Providers ensure our businesses have competitive advantage especially in the area of language and translation services.
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Hassle-free medical and clinical trial translation services in the post-pandemic era
The Covid-19 pandemic has revealed the importance of medical translation as a mostly overlooked albeit essential service in the world of life sciences and healthcare.
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How joint venture models can boost Japan’s pharmaceutical industry
Japan is the third-largest consumer of ethical drugs and the world’s third-largest economy; therefore, it is an important development centre for new medicines. However, there are various cultural and economic challenges in Japan that make it difficult to manage a fixed workforce against a variable portfolio of clinical research.
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Exploring the benefits of biotech partnerships
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases.
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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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Post pandemic clinical trial strategies: How COVID-19 altered clinical trials forever and what’s next
The COVID-19 pandemic forced the clinical trials industry to accept and accelerate the use of digital health technologies.
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Wearables and digital endpoint generation
The key considerations that arise when using digital technology to support endpoint generation in clinical studies.
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Top five digital technologies set to transform pharma R&D
The current wave of emerging digital technologies offers an opportunity to significantly disrupt pharma business operating models in a variety of ways.
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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