Career progression is rarely linear, and there is no single path to leadership. In our latest blog, Sinéad McKeon discusses what drove her move from the lab bench to project management. She reflects on the capabilities...
Filter blogs
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.
-
Encouraging patient participation in real world studies
Real world data offers an alternative approach to observational research, particularly to inform decisions on patient needs and preferences.
-
The impact of COVID-19 on pharmacovigilance
COVID-19 is affecting how clinical trials are managed, in terms of patient recruitment, patient care, data collection, analysis and safety reporting.
-
Wearables and digital endpoint generation
The key considerations that arise when using digital technology to support endpoint generation in clinical studies.
-
Digital intelligence for the clinical trial: How the IoMT is streamlining clinical operations
Rapid progress in connectivity and technology is inspiring innovative clinical trial design.
-
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.
-
-
Can AI improve R&D productivity enough to restore ROI to sustainable levels?
According to an ICON survey, artificial intelligence (AI) was considered the digital technology with the most potential to improve R&D productivity.
-
Adoptive Cellular Transfer (ACT): novel cancer trials demand that participating sites act differently
The evolution of adoptive cellular transfer (ACT) for the treatment of lymphoma, leukaemia and myeloma patients has grown exponentially.
-
Alexa… What’s the deal with voice assistants?
As the buzz around voice technology increases, our digital team is asked more & more, “What’s the deal with voice assistants? Can we offer this to our clients?”
-
The digitization of clinical drug development
ICON expert Dr. Uma Arumugam takes a look at the advancements in digital applications and technology impacting clinical drug development.
-
Why you should consider using a learning management system
Centralising and tracking training requirements for your trials through a learning management system to make it easier for site and study staff.
-
FDA acceptance of clinical data collected outside the U.S.
The US Food & Drug Administration (FDA) amended requirements for the acceptance of clinical data cllected outside the US to support medical device submissions.
-
Making the move to virtual clinical trials late-phase research
Late phase research, once the exception, is becoming the rule. Some post marketing evidence needs can be met with virtual studies, DtP and cyber studies.
-
mHealth devices allow for better treatments and clinical outcomes
Benefits include better, more personalised, treatment and improved clinical outcomes, with fewer clinic visits and greater independence for patients.
-
The power of AI to transform clinical trials
Artificial intelligence (AI) technology, combined with big data, hold the potential to solve many key clinical trial challenges.
-
Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory and Distribution Challenges
Scaling Up CAR-T Therapies Requires Overcoming Manufacturing, Regulatory and Distribution Challenges.
-
Leveraging Voice-Assistant Technology in clinical trials
Voice Assistant technologies provide an opportunity to create a different level of engagement and interaction in comparison to regular apps and web pages.
-
Not if, but when: five cybersecurity threats you can expect
Assess how well equipped you are to meet today’s cybersecurity needs.
-
Addressing the inevitable: managing medical device cybersecurity risks
Cybersecurity threats are among the fastest growing risks for devices connected to private or public networks.
-
Real-time monitoring of the digital patient
Direct to patient strategies and crafting patient centric trials are of increasing interest in drug development trials.
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption: Surveying the industry's evolving landscape
- 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
- mHealth wearables
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Decoding AI in software as a medical device (SaMD)
- Software as a medical device (SaMD)
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Accelerating clinical development through DHTs
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
- Representation 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
-
Prioritising patient-centred research for regulatory approval
-
Accelerating clinical development through DHTs
-
Regulatory Intelligence
-
Accelerating access
-
Meeting requirements for Joint Clinical Assessments
-
Navigating the regulatory landscape in the US and Japan:
-
Preparing for ICH GCP E6(R3) implementation
-
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
-
Exploring FDA guidance for modern Data Monitoring Committees
-
Streamlining dossier preparation
-
Accelerating access
-
Therapeutics insights
-
Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
-
Central Nervous System
-
A mind for digital therapeutics
-
Challenges and opportunities in traumatic brain injury clinical trials
-
Challenges and opportunities in Parkinson’s Disease clinical trials
-
Early, precise and efficient; the methods and technologies advancing Alzheimer’s and Parkinson’s R&D
-
Key Considerations in Chronic Pain Clinical Trials
-
ICON survey report: CNS therapeutic development
-
A mind for digital therapeutics
-
Glycomics
- Infectious Diseases
- NASH
- Obesity
- 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
-
Endocrine and Metabolic Disorders
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Demystifying the Systematic Literature Reviews
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
From bottlenecks to breakthroughs
-
Linguistic validation of Clinical Outcomes Assessments
-
More than monitoring
-
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
-
Clinical trials in Japan: An enterprise growth and management strategy
-
How investments in supply of CRAs is better than competing with the demand for CRAs
-
The evolution of FSP: not just for large pharma
-
Embracing a blended operating model
-
Observations in outsourcing: Survey results show a blended future
-
Clinical trials in Japan: An enterprise growth and management strategy
-
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
-
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
-
Integrating openness and precision for competitive advantage
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel