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Measuring the impact of ICH E9(R1) on UK research protocols
The ICH E9(R1) Addendum, adopted in November 2019, aims to clarify treatment effects in clinical trials. Tim Clark, ICON’s VP of Clinical Sciences, co-authored a study reviewing how UK research protocols apply estimands and how usage has evolved since the addendum’s adoption.
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Modern tools for cardiovascular studies
Cardiovascular disease is the leading global cause of death, driving urgent research efforts. CV studies are key to evaluating heart-related treatments and impacts. Digital health technologies (DHTs) now play a growing role, improving data capture and patient-centricity in CV research.
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Reimagining clinical programming: The strategic role of R in modern trials
This blog explores how adopting R is transforming clinical programming by meeting growing complexity, tighter timelines, and the need for transparency, positioning it as a catalyst for innovation across pharma and biotech.
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Getting the values right: Which QT correction formula is most accurate in healthy volunteers?
ICON assessed ECGs from 22,063 medically healthy individuals participating in phase 1 trials between 1997-2023. Learn which QTc formula performed best in age, sex, BMI and heart rate subgroups.
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Rising to the challenge with innovative therapies
Global regulators are streamlining access to innovative therapies—but navigating these pathways takes strategy. From FDA’s Breakthrough to EMA’s PRIME, early planning and expert partnerships make the difference.
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Beyond tradition: An analysis of modern vaccine technologies
This blog explores some of the most promising non-viral vaccine development platforms, highlighting their mechanisms, advantages, and limitations.
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How Project Optimus has impacted oncology-focussed biotech companies
By focussing on dose-optimisation the FDA’s Project Optimus is changing how oncology-focussed biotechs develop their treatments.
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The importance of stability programs in early clinical drug product development
Stability studies assess how a drug’s quality changes over time under environmental stress like heat, humidity, and light. They ensure safety and efficacy throughout the product’s lifecycle, supporting reliable clinical data and regulatory approval.
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To avoid HTAR bottlenecks NICE and MHRA offer a strategic alternative
This blog explores how drug and medical device developers can engage with the MHRA and NICE as a strategic alternative when access to Joint Scientific Consultations (JSCs) is limited.
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How GCP updates make way for an RBQM revolution
Explore how the new ICH GCP E6(R3) empowers sponsors and CROs to strategically innovate and optimise trials by embedding RBQM at the core of quality management.
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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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Oncology biosimilars on the rise: Key clinical development insights
As cancer treatment advances, biosimilars are becoming key players in oncology. While biologics have improved outcomes, their high costs remain a barrier. Biosimilars offer a more affordable alternative, closely replicating biologics whose patents have expired.
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Why long-term follow-up should start early in vaccine trials
Learn more about why demonstrating long-term safety should start early in vaccine trials. With early planning, vaccine developers can gather real-world data and evidence needed to help individuals make informed decisions about vaccination.
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The revision of ISO 10993-1 – what does it mean for medical devices?
Biological evaluation is a toxicological risk management process. The revised standard, expected by year-end, places it in proper context, emphasizing Clause 4's unchanged principles. The update aligns evaluation with ISO 14971 and accepted toxicological risk assessment practices.
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The real weight of real-world data: Key factors for successful real-world data RFP/RFI
Learn key factors for making the right RWD supplier selection and the hidden complications in seemingly straightforward numbers.
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Navigating post-market access and adoption of biosimilars across APAC
Post-market success of biosimilars depends on public health needs, reimbursement, and safety monitoring. Sponsors must navigate diverse regulatory and market landscapes. This analysis explores key post-market strategies in major APAC countries, including China, Japan, India, Singapore, and South Korea.
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The future of clinical trials: Why patient-centric outcome measures matter
In recent years, clinical trials have shifted toward a more holistic, patient-centred model. This approach values patients as experts in their own conditions, offering critical insight into whether treatments truly address their needs and priorities. But how do researchers determine which measures reflect what truly matter to patients?
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Why assessing the pharmacokinetics of antibody-drug conjugates is so complex
In this article we look at some of the challenges of typical bioanalytical ADC assays and some recent developments in the area.
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(Re)Designing schizophrenia trials: Lessons from the frontlines of CNS research
There is room for improvement in schizophrenia trials, and small decisions make a big difference. Read what experts say about designing and implementing trials to overcome persistent challenges.
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Rethinking women’s health
A review of the availability and application of COAs within the context of the FDA’s roadmap highlighted several patterns and gaps in how women’s health is currently evaluated across therapeutic areas.
