Filter blogs by either clicking within the ‘Category’ drop-down list, or begin typing which will automatically match to the nearest available category.
-
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.
-
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.
-
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.
-
Biotech’s evolving relationship with CROs
In this blog, read more on recent trends and learn why strategic outsourcing is a key opportunity.
-
Recent trends in the biotech funding environment
In this blog, discover more about how the biotech sector is transforming uncertainty into opportunity.
-
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.
-
Pre-emptive vaccine research to improve EID response
This blog explores strategies for strengthening vaccine development so that the medical community is better prepared to respond to future epidemics.
-
Use of ddPCR and qPCR assays for PK and safety monitoring in Cell & Gene Therapy clinical trials
Immunotherapy technologies are rapidly advancing, as are the methods of ensuring their safety and reliability. ICON explores the tools used in CGT trials.
-
From clinician visits to data analysis: the challenges and solutions in COVID vaccine pharmacovigilance
Learn more about the challenges and solutions in assessing the long-term effects of Covid and Covid vaccines in this blog.
-
Mary O’Reilly reflects on International Women’s Day
In this blog, Mary O’Reilly reflects on the International Women’s Day panel and events held at ICON’s global headquarters in Dublin.
-
How data science is changing the face of healthcare
In this podcast, Michael Goedde shares his journey in technology and his role in building the digital platform for healthcare systems at ICON.
-
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.
-
Rare Disease Day diversity and inclusion
This event aims to raise awareness about the diversity of individuals affected by rare diseases. Find out how virtual events can be made more accessible and inclusive.
-
-
My patient story - Claudia Egremont-Lee
ICON's Claudia Egremont-Lee shares her personal experience with breast cancer.
-
My patient story - Margaritte De Falco
ICON's Margaritte De Falco shares her personal experience with ovarian cancer.
-
The importance of developing rTPP to build biotech asset value
Discover how Biotechs can build value into their asset by developing a reimbursable Target Product Profile (rTPP).
-
The impact of real world evidence on drug marketing approval and reimbursement
Increasing use of real world data and real world evidence for market regulatory decisions can lead to a more holistic understanding of safety and potency factors for healthcare practices.
-
Redefining sourcing model terminology
This blog explores the new framework for defining CRO sourcing models and explains its importance.
-
Optimising biotech trial designs to stretch your cash runway
Read this blog to learn a few key considerations to help optimise and de-risk your trial design.
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption whitepaper
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel