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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The future of RWD and RWE in healthcare decision-making: Applications of novel real-world data collection methods for healthcare decision-making
Read insights from Jennifer Eriksson, Divisional Principal, on the use of real-world evidence and real-world data to inform healthcare decision-making and provide patients with rapid access to innovative healthcare technology.
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ICON interview: Insights on the new EMA guidelines for computerised systems and electronic data in clinical trials
Outsourcing Pharma spoke to Vesta Marciulioniene, director global regulatory clinical services at ICON Biotech, who shares her insights on the new EMA guideline for computerised systems and electronic data in clinical trials and what new expectations it sets for the clinical research industry.
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Implications of regulatory and FDA guidance on diversity, equity and inclusion on clinical research study sites
Following discussions at the 2023 Global Site Solutions Summit, Missy Gottschlich, Director of Site Networks for Accellacare, provides key insights on how sites can implement regulatory guidelines on diversity, equity and inclusivity in this article in pharmaphorum.
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Confidently compliant? Considerations for industry players to meet the new EMA guideline
Vesta Marciulioniene, Director, Global Regulatory Clinical Services and Jo Hulbert, Executive Director, Global Regulatory Clinical Services provide an overview of the EMA’s new framework on computerised systems and electronic data in clinical trials in this article from XTalks Clinical Edge.
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Essential considerations for a successful submission under EU CTR
A key feature of the EU CTR is the introduction of a single electronic portal, the Clinical Trial Information System (CTIS), which is mandatory for all EU CTR submissions. CTIS enables harmonised and simplified end-to-end electronic application procedures over the lifecycle of clinical trials across the EU/EEA.
Published by International Biopharmaceutical Industry Journal Volume 6 Issue 2
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Comparing treatment performance through evidence synthesis
If there is a variety of treatment options in a specific disease area, decision makers require evidence of efficacy and safety of novel interventions in comparison to established treatments. One randomised controlled trial (RCT) is not sufficient to come to a final conclusion, especially since RCTs often present contradictory results.
Published by Journal for Clinical Studies Volume 15 Issue 2 (https://journalforclinicalstudies.com/).
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Regulatory considerations in technology for decentralised clinical trials
This article in the Journal of mHealth explores the guidance regulators have provided for diversity and inclusion in clinical trials, privacy considerations and endpoint selection, and is authored by Jo Hulbert, Executive Director, Global Regulatory Clinical Services with contributions from Arwa Shurrab, Senior Director, Global Regulatory Affairs and Priti Prasad, Senior Manager, Global Regulatory Affairs.
Copyright 2023 The Journal of mHealth (Simedics Ltd)
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Global collaboration: Irish company ICON on scaling up COVID-19 vaccine trials
An interview in which Steve Cutler gives a short overview of ICON and describes the company’s role in the Pfizer/BioNTech trial, explaining how the FDA played a critical role in expediting regulatory approvals.
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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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Encouraging patient participation in real world studies
Real world data is rapidly becoming the latest frontier for life sciences companies for supporting regulatory filings and conducting drug safety surveillance. ICON experts discuss the critical role of patients and advocacy groups in the June issue of Pharmaceutical Market Europe.
