Contents In this issue 8
6 News in numbers The headlines and figures impacting the sector.
Regulatory
8 Beyond beta testing With just one year left before all ongoing clinical trials in the EU must transition to the Clinical Trials Information Systems (CTIS), marking the end of the three-year transition period since Clinical Trials Regulation came into effect in the EU, Jim Banks speaks to Lene Grejs Petersen, senior advisor, Danish Medicines Agency and Inge Christoffer Olsen of the Department of Research Support for
12 4 Data management
12 Generative AI: Can it be trusted? In the era of precision medicine, generative AI is poised to revolutionise clinical trials as a formidable tool. As healthcare becomes more data-driven, integrating advanced technologies such as artificial intelligence (AI) into clinical trials promises to deliver faster, more efficient medical research and expedite the development of new treatments.
Clinical Trials, Oslo University Hospital about the most recent updates, challenges and benefits the new regime has brought about.
Clinical Trials Insight discusses the transformative potential and ethical implications of this technology with Jonathan Crowther, PhD, site intelligence lead, study optimization, global product development, Pfizer.
Clinical supply & logistics
15 Hope and understanding The benefits of access programmes for clinical trials extend beyond patient recovery and treatment. Providing patients with treatments or drugs that have not yet been approved in their country is advantageous not just for patients, but for all stakeholders involved. Phoebe Galbraith speaks to Sheela Upadhyaya to explore how the benefits of access programmes can be maximised and how best to design a programme to meet everyone’s needs while managing outcomes and uncertainties.
18 A logistical gateway: Critical support for European clinical trials Yourway
21 Elevating clinical trials: The intersection of speed, efficiency, and connectivity Marken
22 Breaking the cost barrier In the ever changing landscape of clinical trials, markets have increasingly
15 Clinical Trials Insight /
www.worldpharmaceuticals.net
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