Blog
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Streamlining early phase clinical trial submissions under the EU CTR
The EU Clinical Trials Regulation (CTR) represented a significant shift in the regulatory landscape, aiming to create a more favourable environment for clinical research across Europe.
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Transforming CML patient monitoring with ICON’s innovative RNA-based NGS assay
ICON's new RNA-based NGS assay improves CML monitoring, offering higher sensitivity and specificity, including for the identification of typical and atypical BCR::ABL1 transcript types and the detection of TKI resistant mutation.
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Insights from PSI 2024: Advancements in digital health technology
ICON’s statisticians share insights from the PSI’s 2024 conference where they presented on advancements in digital health technology and decision making.
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Defining the differences when regulating medical devices, medicinal and combination products
A basic guide to the complex regulations governing clinical trials which involve medical devices and medicinal products.
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Pushing boundaries in idiopathic pulmonary fibrosis clinical research
The landscape of IPF research is evolving and early-stage biopharmaceutical teams need a new roadmap to success. We offer strategies to meet the challenges to develop new treatments.
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Essential components of a successful global labelling process
By incorporating these essential components, global labelling processes increase their fundamental impact on delivering an efficient drug development program.
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Innovative approaches to ensuring participant safety in early phase clinical research
Early phase clinical research is key to refining the safety profile of new drugs and proof of concept, expanding on the data gathered in preclinical studies. With innovative tools and unique collaboration models, ICON is driving more proactive participant safety measures to effectively mitigate risks.
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How human-enabled AI is creating a new map for navigating site selection
Discover how AI transforms site selection in clinical research by leveraging data and human expertise through an ecosystem approach to optimise site ranking, patient enrolment, and study timelines.
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Navigating shifting paradigms in dose optimisation and dose selection for oncology therapeutics
The maximum tolerable dose (MTD) is increasingly seen as suboptimal for emerging oncology therapies, which lack chemotherapy’s generalised cytotoxic effects. More contemporary dose-selection designs can now identify the lowest dose of an oncology therapy with the highest rate of efficacy that is tolerable for patients. Learn more.
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Innovations contributing to the reemergence of antibody drug conjugates
ADC candidates that address the limitations of their first-generation predecessors are receiving approvals, and a new wave of ADCs are in clinical development. Read the blog to explore the innovations contributing to the re-emergence of ADCs.
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Navigating oncology development decisions for long-term success
Read the blog to learn how to navigate key challenges in oncology and the important decision points including early clinical development, robust registrational strategy and late-stage development.
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Leveraging healthcare intelligence to increase diversity of oncology clinical trials
New regulatory requirements for diversity require sponsors to submit a diversity action plan alongside key trial documents to the FDA. Read the blog to learn how healthcare intelligence can be leveraged to increase diversity in oncology clinical trials.
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Veeva R&D and Quality Summit 2024
A conference on research, development and quality shows that collaboration is crucial to advancing life sciences. Three ICON clinical data scientists share what they learned.
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The rise and role of AI in medical imaging
Discover how AI is revolutionising medical imaging and clinical trials, enhancing efficiency, accuracy, and patient outcomes through innovative applications in oncology, cardiology and more.
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Digital health : patient safety and the next frontier
Medical and wearable devices, remote in-vitro diagnostics and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.
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ICON at SCDM 2024: Connecting the dots of clinical data management
Four ICON experts shared insights at the 2024 Society for Clinical Data Management conference across topics of RBQM, change management, data managers and diversity.
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Navigating regulatory landscapes: A guide to global submission standards
This blog summarises the key insights and recommendations from our recent webinar, offering a guide for pharmaceutical stakeholders navigating the complex terrain of regulatory submissions.
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Integrating Performance Studies of In-Vitro Diagnostics into Clinical Trials: A Complex Challenge
Integrating performance studies of IVDs within clinical trials is a complex yet essential endeavour in advancing healthcare innovation. We explore how to navigate the nuances of regulations and embrace collaborative initiatives to overcome challenges and unlock the full potential of combined trials.
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SDoH data analysis for proactive outcome improvement: A multilayered approach
Social determinants of health affect patients in widely variable ways, and proper, multi-layered analysis is required to gain actionable insight into patient healthcare consumption and behaviour to optimise brand strategy and deliver better solutions and services to patients.
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Navigating the complexities of healthcare data types
Navigating the landscape of healthcare data has become increasingly challenging amidst a multitude of data types including open and closed claims sets. Choosing the appropriate foundational dataset will empower data-driven solutions to your business questions.