Blog
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How global capability centres deliver value for healthcare companies
This blog highlights how healthcare companies are leveraging global capability centres in India to drive value through skilled talent, cost advantages and a supportive business environment.
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Post-marketing pharmacovigilance: Ensuring product safety in the real world
Explore the critical role of post-marketing pharmacovigilance in protecting patients and maintaining compliance after your product enters the market.
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Technology and tokenisation: Reflections from the 2025 World Vaccine Congress
Dive into the main themes, topics and outlooks from the 2025 WVC, held in Washington, D.C., where ICON presented and was recognised at the ViE Awards.
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Oligonucleotide progression into early phase studies
In this blog, we explore the importance of quality control testing for oligonucleotide formulations in early-phase clinical trials. While not fully addressed by ICH Q3A/Q6A, these products must comply with parts of EU GMP Annex 1 and the draft EMA guideline to ensure regulatory readiness.
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Cultural Shift of ISO 13485: 2016 Implementation for the FDA
In this blog, we explore the FDA’s Jan 2024 update to 21 CFR 820, now QMSR, aligning U.S. device standards with ISO 13485:2016 for global consistency.
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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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Driving MAA success: Why every submission team needs a regulatory project manager
Regulatory project managers are the guiding force behind successful MAA submissions. Learn about their role in delivering accelerated, harmonised, high-quality MAAs.
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Tallying the TrOOPs: Tracking cost implications under IRA Part D reforms
Get insights into how the 2025 IRA reforms change how Medicare patients accumulate out-of-pocket spend and how the cost burden shifts between stakeholders.
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CMC IMP considerations for Oligonucleotides
There are numerous strategies being developed to enhance the delivery of oligonucleotides, potentially changing the formulation and mode of drug delivery. However for now, we have to manufacture a sterile injection formulation.
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Minimising impurity formation in oligonucleotide synthesis
In the first installment of our three-part series, we provide an introduction to oligonucleotide therapeutics and examine how API synthesis strategies impact impurity formation, highlighting best practices for risk mitigation.
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When and why sponsors should seek MHRA advice
Sponsors can seek scientific advice from regulatory agencies for many reasons. Learn when to seek MHRA advice and the benefits in comparison to other agencies.
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Adaptive trials and the new draft FDA guidance on data monitoring committees
The FDA’s recently released 2024 draft guidance on DMCs is the first update since 2006, marking an important renewal of emphasis on DMCs for modern clinical trials. Here we explore how some of these planned changes to the guidance will affect DMCs in relation to adaptive trials, including management, statistical analysis and delivery.
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Notes on tomorrow’s biotech: Insights from BIO-Europe Spring’s expert panel
ICON’s SVP of Drug Development Solutions, moderated a panel on biotech ecosystem innovation with global industry experts. Read their insights below.
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A partnered perspective on the 2025 Medidata NEXT conference
ICON sponsored and presented at the 2025 Medidata NEXT conference in London, unveiling our Clinical Data Studio integration and discussing innovations in clinical data science and support efficient trials. Read key insights here.
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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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Clinical trial protocol design amid evolving global IVD regulations
Clinical trial protocol design considerations driven by the current global evolution in vitro diagnostic device regulations impacting clinical testing laboratories.
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Navigating Pediatric Drug Development (PDP) in Canada: A comprehensive guide part 2
In the previous blog of this series, we introduced the pilot PDP initiated by Health Canada including the types of PDP that can be submitted and the content and format of a C-PDP. This blog discusses the review of PDPs by Health Canada, amending agreed-to PDPs and annual reporting requirements.
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Validated tokens: The key to following the patient journey
Increasingly, sponsors are finding value in integrating clinical trial data with real-world data and precision medicine data to follow patients through the continuum of care, beyond their trial participation.