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Early-phase clinical trials serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market. However, these early stages present significant challenges—nearly half of all drugs entering clinical trials do not make it past phase 1. With the average phase 1 trial costing millions of dollars and consuming valuable time, biotechs have little room for error. This article discusses how partnering with a CRO can benefit a small biotech - helping to fill the gaps in knowledge, resources infrastructure.
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Kathleen Mandziuk, Vice President of eClinical Development & Delivery, offers insights on the persistent challenges of patient recruitment, the revolutionary role of AI and digital tools, and the critical importance of diversity and inclusion.
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For sponsors considering how to most efficiently and effectively allocate resources, innovative trial designs offer advantages. In early phase trials—specifically, phase I and II trials involving safety, dosing, and proof of concept—innovative designs offer potential for improvements in efficiency and decision-making, as well as lowering costs. Innovative trial designs, such as adaptive trials, Bayesian methodologies and master protocols, can be utilised to add value when used in early phases.
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As the cost of developing new therapies continues to rise, pharma executives must turn to technologies that drive better insights into de-risked investments and produce operational efficiencies. AI-powered digital measures are being developed and validated to better define disease, patients, and drug efficacy.
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Read insights from Harpreet Gill VP, Real World Solutions, on how sponsors can optimise their LTFU studies to be flexible and cost-effective, with strategic planning and innovation, overcoming challenges while capturing valuable data insights.
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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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With the increasing adoption of COAs, the importance of standardization across training, collection, and implementation to ensure high quality and consistent data collection has become apparent in recent decades.
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In this interview with Asia Business Outlook Magazine, Nagalakshmi Shetty, Vice President & India Country Head shares how changes in data management have changed the way clinical research is practiced and emphasises the role of interdisciplinary collaborations in progressing research.
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This article by Gerard Quinn, Vice President of IT Innovation and Informatics, which appeared in PharmaTimes Magazine, delves into how AI is transforming clinical trials by improving efficiency, accelerating timelines, and enhancing decisions across the clinical development process.
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In this article Rebecca A Rozich, Director, Client Engagement & Medical Strategy at 91黑料 shares how to effectively measure the true impact of campaigns across social media, disease education and marketing initiatives.
