Blog
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For biotech success: Start with the end in mind and develop a TPP early
Industry experts advise biotechs seeking funding to develop a TPP early, avoid short cuts and overselling. Get strategies for success in this blog.
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Breakfast with biotech: Expert insights for early-stage innovators from Bio€quity Europe 2025
ICON hosted a candid and insightful Breakfast Workshop on de-risking early-stage biotech. Read the key points and recommendations for the turbulent market, killer experiments, and balancing risk.
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Solving common challenges to develop oncology combination therapies
ICON surveyed oncology developers in North America and Europe to explore challenges in therapeutic development. This article highlights key findings and offers strategies to de-risk combination therapy trials—explored further in our whitepaper.
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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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Writing, managing, leading: The multifaceted role of a successful medical writer
This blog highlights the critical role of project management, leadership, and communication in medical writing. Learn how these skills contribute to high-quality, timely submissions.
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Project management tips for successful MAA, NDA or BLA submission preparation
From personalized medicine to AI-driven discovery, pharma innovation is accelerating. Gaining market approval requires strong cross-functional teamwork. This article shares project management tips to help you avoid pitfalls and prepare confident, high-quality submissions.
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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.