Participant-centric study design has advanced, but site-centric execution has not kept pace. In the Journal for Clinical Studies, Brian Mallon examines how unclear expectations, administrative burden and contract delays ...
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COVID trials vaccine firm ICON announces €10bn US takeover deal
ICON has announced one of the biggest takeover deals in Irish corporate history.
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ICON to buy contract researcher PRA Health for $12B
ICON will buy PRA Health Sciences for about $12 billion in cash and stock, snapping up one of the larger independent companies in the drugmaker services business.
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ICON plc acquires PRA Health Sciences Inc. in $12 billion acquisition
In a cash and stock transaction value of approximately $12 billion, ICON plc has announced its acquisition of PRA Health Sciences as part of a focus on innovative and high-quality clinical trials.
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CRO consolidation continues with ICON buying PRA Health Sciences for $12B
ICON is set to acquire rival PRA Health Sciences in a $12 billion deal that will vault the combined company into second place among clinical trial services providers.
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Decentralised, hybrid or traditional: Choosing the best option for your clinical trial
In this article, EB McLindon offers insights to help sponsors decide which approach is most optimal for a clinical trial.
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Best practices in managing CGT from protocol design to data management
Though the fields of immunotherapy and cell and gene therapies have seen significant growth since April 2012, CGT clinical research remains a challenge. ICON's Tamie Joeckel offers expert commentary on managing and executing CGT clinical trials.
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COVID-19 trial of alternating vaccines begins in the UK
Recruitment has begun in the UK for a world-first study to investigate whether using different COVID-19 vaccines for first and second doses is as effective as using the same type of vaccine for both. ICON’s Dr Garrett provides commentary.
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No10 launches world's first trial into whether mixing and matching coronavirus vaccines can enhance protection
ICON's Dr. Garrett comments on the UK government's new 'Com-Cov' study of over 800 patients, designed to test mixing doses of the Oxford and Pfizer COVID-19 vaccines, as well as different intervals between doses.
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Navigating the EU’s IVDR compliance deadlines amid uncertainty
With the COVID-19 pandemic, Brexit, and the rapidly approaching deadlines to comply with the new European Regulation on in vitro diagnostics (IVDR), IVD manufacturers will need to prepare for an ever-evolving clinical and regulatory landscape, and create mitigation strategies that allow for quick, agile changes to keep studies on track. Additionally, manufacturers will need to adopt a strategy to address gaps in meeting new regulations to avoid potential UK and European Union product availability issues. Understanding current guidance and adapted regulations is the first step to navigating the transformations undergoing the diagnostics field and the broader healthcare industry. In this article, Angela Brown and Nicole Cowan provide an overview of today’s regulatory setting and discuss how manufacturers can develop strategies to ensure a successful transition to comply with the IVDR by the 2022 deadline, including: overcoming the shortage of Notified Bodies; assessing product portfolios and quality systems; planning and implementing technical file remediation; and managing the IVD lifecycle.
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Shaping the future
An article discussing how the pandemic spread caused disruption but also a rapid deployment of solutions to ensure continuity in clinical trials and preserve and build resilience into ongoing research programmes.