All articles by Staff Writer

Staff Writer

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.

Bridging silos for smarter clinical trials

The landscape of clinical trials is increasingly complex, with data playing a pivotal role in shaping research outcomes. Data management, biostatistics, and data standards are essential pillars of this ecosystem, yet they often operate in silos. Adding external vendors to the equation 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.

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.

Bridging silos in clinical trials data

The success of clinical trials relies on integration of various functions, yet silos between Data Management, Biostatistics, Data Standards, and External Vendors remain a challenge. Here eClinical solution company CRScube explores three key areas – system cooperation, task-oriented approaches, and data standards – to bridge these silos effectively.

A game-changer for clinical trial design

Cytel, a leading provider of cutting-edge analytical solutions, quantitative methods, and innovative statistical software for the life sciences industry, has just unveiled an innovative platform that represents a significant advancement in the field of clinical trial design and simulation: East Horizon™. Building on more than 30 years of experience, Cytel has developed a cloud-native, intuitive platform that promises to significantly accelerate the drug development process, making clinical trials more efficient, cost-effective, and reliable. Clinical Trials Insight hears from Kevin Trimm, chief product officer and Aniruddha Deshmukh, VP of Software Engineering at Cytel to find out more.

Regulatory pathways for medical device clinical trials

This article summarises the procedures to get study approval for medical device clinical trials. Along with the intricacies of the Medical Device Regulation (EU) 2017/745, Lumis Life Science Consulting provides an important summary of medical device study classifications and the corresponding submission pathways.

What happens when data is better prioritised?

Drug development is rife with complexities. Success hinges upon managing them effectively. Data is the ultimate deliverable of any study, and treating it with the utmost focus is a responsibility owed to study participants and, ultimately, future patients. This has become even more important as the complexity of clinical trial data structures and collection modalities has proliferated. Clinical Trials Insight speaks with Ben Dudley chief commercial officer at MMS, a data-focused CRO with operations across the United States, about a new approach to integrating biometrics and regulatory aspects of the industry.

Plotting a course toward content automation

With Generative AI reshaping content automation, organisations must ensure they select technology that is scalable and fit for purpose. Here Vladimir Penkrat, associate vice president – regulatory affairs at Indegene, parent company of Trilogy Writing & Consulting, discusses strategies for evaluating and adopting such technologies.

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.

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.