Contents In this issue 6 Regulatory
6 Easing the clinical trials pathway
As The Accelerating Clinical Trials in the EU launches two new advice pilots aimed to improve the quality of applications for clinical trials, in a further attempt to build a firmer foundation for the development of safe and effective medicines in Europe, Jim Banks explores how these will help researchers to navigate the technical and regulatory requirements of the new regime.
9 Plotting a course toward content automation Trilogy Writing & Consulting
Outsourcing
12 Uncovering the CRDMO advantage
Bringing a new drug to market is always complicated, especially when working with multiple outsourcing partners. As a result, we are seeing a shift towards integrated CROs and CDMOs, which can offer everything from drug discovery to clinical trials under one roof. Abi Millar speaks to Kevin Li, chief marketing officer of BioDuro-Sundia, and Jennifer Cannon, president commercial operations pharma services at Thermo Fisher Scientific, to find out more.
Clinical Trials Insight /
www.worldpharmaceuticals.net
15 What happens when data is better prioritised? MMS Holdings
17 Regulatory pathways for medical device clinical trials Lumis Life Science Consulting
Trial design
18 Predict, design succeed We are in the midst of a paradigm shift towards digital solutions for designing and running clinical trials. These tools and models, from generative AI to digital protocols, allow for easy exchange of information and offer insights to assist in trial design. In some cases, they can even increase
the odds of a trial’s success. Monica Karpinski explores the potential of these novel approaches.
21 A game-changer for clinical trial design Cytel
Clinical supply and logistics 24 Chain reactions
The future is digital, and the clinical trial supply chain is no exception. Sarah Harris speaks to Kelly Archer, managing partner, and Erika Biggadike, head of supply chain, at 4C Associates, as they discuss how to optimise clinical trial supply chain management through digital process and automation to improve supply chain visibility and communication across all stakeholders.
28 Cooling the cold chain With the push to go green showing no signs of stopping, what are the latest technological advances and systems in the cold chain industry that should be on everyone’s radar? How can businesses align market growth with saving the planet? Abi Millar investigates, speaking to Tom Rose, SVP of clinical trial sourcing at Clinigen, along the way.
Data management
31 Bridging silos for smarter clinical trials
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The clinical trials landscape is increasingly complex, with data playing a pivotal role. Data management, biostatistics, and data standards are essential pillars of this ecosystem, yet they often operate in silos. Adding external vendors further fragments the process, potentially leading to inefficiencies and compromised data integrity. To achieve transparency, efficiency, and robust data integrity, the industry must address these silos and foster seamless collaboration across all stakeholders. Phoebe Galbraith speaks to Mike Martin, principal, and Bazgha Qutab, principal, at ZS Associates.
34 Bridging silos in clinical trials data CRScube
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