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Continuing the fight against AMR with new tools for diagnosis and treatment
The employment of antimicrobials to fight previously devastating microbial diseases, such as tuberculosis, meningitis and pneumonia, has been credited as being one of the most transformative medical achievements of the 20th century.
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The impact of paediatric medical trauma in clinical trials
Up to 80% of children and their families experience paediatric medical trauma after medical interactions of significant illnesses. Read the insights shared by a panel of Paediatric Medical Trauma Working Group members to learn how patient-centric paediatric trials can help mitigate the potential for medical trauma and its life-long implications.
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Navigating CTIS: Setting up clinical trials under EU CTR
The EU CTR Nº 536/2014 came into force on 31 January 2022, repealing the Clinical Trials Directive and improving the harmonisation of clinical trials regulation throughout the EU and European Economic Area (EEA).
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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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Expanding CAR T-cell Therapy into solid tumours
In this blog, learn more about a range of approaches that researchers are taking to improve the efficacy and safety of CAR T-cell therapies in solid tumours.
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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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Highlights from the revised Medicare Drug Price Negotiation program guidance
Explore revised guidance instructions related to the Medicare Price Negotiation program in this blog.
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CMS Medicare Part D Price Negotiations
In this blog find more about a current list of drugs likely to be selected for negotiation, with their same-in-class competitors.
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The new EMA guideline expectations
In this blog, discover more about the new EMA guideline on computerised systems and electronic data in clinical trials.
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Patient-centric best practices for improved diversity
In this blog, we share best practices for a more patient-centric approach to trials as discussed in our webinar to improve accessibility, inclusion and diversity.
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Disease surveillance in low- and middle-income countries
Disease surveillance and reporting is critical to public health, enabling faster and better response to infectious disease outbreaks.
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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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Disease surveillance and innovative vaccines
Learn about current approaches to disease surveillance and why they are important for the advancement of vaccine development in this blog.
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EU CTR: Practical experiences and lessons learned
EU CTR effective January 31, 2022, introducing new age for interventional clinical trial applications in EU and EEA. Read more about the practical experiences and lessons learned.
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Rare diseases and orphan drugs regulatory framework in Canada
This blog details initiatives that are being taken by the Government of Canada to promote a health care system that works for those with rare disorders.
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The impact of the new EU Clinical Trial Regulation on language translation
On January 31st, 2023, the EU Clinical Trial Regulation and the Clinical Trial Information System went live and changed the European landscape for clinical trials.
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Biotech’s evolving relationship with CROs
In this blog, read more on recent trends and learn why strategic outsourcing is a key opportunity.
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Recent trends in the biotech funding environment
In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.
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Improving the experience of healthy volunteers during early phase clinical trials
How ICON’s application of a volunteer-centric approach is improving recruitment and retention rates of healthy participants in early phase studies.
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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Videos
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Webinar Channel