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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Advancing patient-centred outcomes in sleep medicine
PLATO‑11 is a newly validated, freely accessible patient‑reported outcome instrument developed by ICON in collaboration with the American Academy of Sleep Medicine to address long‑standing gaps in patient‑centred assessment for obstructive sleep apnoea. Built through rigorous qualitative and quantitative research, PLATO‑11 captures the real‑world, day‑to‑day impact of OSA and supports more personalised, evidence‑based care in both clinical practice and research.
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Managing AI model biases in AI-enabled SaMDs
Medical device developers using AI in software as a medical device must avoid AI biases to optimise their SaMDs and limit health disparity perpetuation.
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Understanding FDA regulations for AI in SaMD
Despite an increase in AI-enabled medical devices receiving FDA approval there is no distinct regulatory route. Learn about FDA guidance on AI in SaMD.
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Designing Delphi panels: A useful, non-standardised tool for patient-centric research
ICON’s PCO experts outline how to successfully design different types of Delphi panels for expert consensus, patient-centric COA and ClinRO development.
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Behind Biotech: Heidi Hoppe
When Heidi Hoppe began her career more than two decades ago, she didn’t plan on becoming the Senior Director of Project Delivery for Biotech at one of the world’s largest CROs. She hadn’t planned on being in the industry at all.
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Behind Biotech: Bojana Mirosavljevic
When companies seek support with rare disease patient advocacy, ICON Biotech’s Bojana Mirosavljevic brings hard won insights. As an embryologist and mother of a rare disease patient, she sees patient advocacy from the dual perspectives of science and caregiver.
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Behind Biotech: Mark Sorrentino
One would expect a driven and empathetic person at the helm of the industry’s leading pediatric clinical development centre, but Mark’s particular brand of tenacious empathy would undoubtedly surprise you.
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Why integration is essential for outsourced regulatory submissions
Greater efficiency in global regulatory submissions is possible with an integrated regulatory and translation services delivery model.
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Protocol predictability: Refocusing through the lens of site and patient engagement
Site and patient engagement is the key to optimised protocol that accelerates study start-up. Explore how refocusing protocol drives faster, more feasible and efficient clinical trials.
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Implementing digital health technologies for patient-centred trials
DHT adoption is growing as a way to de-risk clinical trials. But effective use of these technologies requires a structured approach to mitigate risks and maximise value. This blog and accompanying webinar provide a step-by-step guide to success with DHTs.
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Controlling complexity for regulator-ready protocol
Discover how a data-driven approach to protocol optimisation can reduce complexity, minimise costly amendments, and improve both regulatory readiness and patient-centricity in clinical trials.
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Collaborating for protocol perfection: a holistic approach to protocol design
In our latest blog, discover how early consultation on protocol development and a structured, data-driven evaluation process can result in scientifically sound, operationally efficient, and patient-centric protocols.
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Why translating core dossiers for marketing applications requires more than language skills
In this blog we outline why adoption of eCTD dossiers has increased and why translation requires regulatory expertise as well as language skills.
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The future of medical science depends on transparency: Why plain language summaries matter
In this blog, we explore the industry’s response to this new era of clinical trial transparency, why it’s fundamental to the future of medical science, and how the nuances of public awareness can be quite complex.
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A clinical trial linguist’s perspective on machine translation
Perspectives on what machine translation means for clinical trial translations from an experienced clinical trial linguist.
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How COAs and DHTs offer deep insights into patient experiences and treatment effects
A conversation with Sonia Bothorel, Managing Director, Mapi Research Trust and Outcome Measures Solutions.
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The importance of communication in patient-centred clinical trials
How can we navigate this complex linguistic landscape while preserving the integrity of the original message and keep participants well informed?
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The importance of a robust clinical outcome assessment strategy in your clinical trial
At ICON, we understand the nuances involved in creating a COA strategy that not only meets regulatory standards but also resonates with patients and stakeholders alike.
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Maximising clinical trial success with integrated language services
Translation management is a critical component in global clinical trials - accurate and culturally appropriate communication is non-negotiable. Learn the importance of integrated language services in clinical research.
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Why using COAs and DHTs together is the future of clinical research
Though both COAs and DHTs are tools used to evaluate a treatment’s impact, they often exist in separate spheres, rarely integrated. We argue that combining these two approaches in the same study can help researchers gather better data and improve the likelihood of regulatory approval.
