All articles by Staff Writer
Staff Writer
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.
Frontier Scientific Solutions Unveils Plans for a Global Free Trade Zone (FTZ) Gateway
Frontier Scientific Solutions, a temperature-controlled storage and transportation company exclusively serving the life sciences industry, today announced the development of state-of-the-art cGMP facilities at Wilmington International Airport (ILM) in North Carolina and Shannon Airport (SNN) in County Clare, Ireland.
Genezen Welcomes Industry Experts Dr. Pam Stetkiewicz and Stuart Auerbach to Board of Directors
Genezen, a best-in-class gene therapy contract development and manufacturing organization (CDMO), is pleased to announce Dr. Pam Stetkiewicz and Stuart Auerbach have joined its Board of Directors.
What is comparator sourcing in clinical trials?
When it comes to clinical trials, sourcing comparators can be a challenge that could expose companies to various roadblocks. There are so many factors to consider, from regulatory and operational risks to cost and waste targets. Tom Rose, SVP of clinical trial sourcing at Clinigen, explains how these risks can be managed and why it’s so important to have a contingency plan in place.
Everything you need to know about adaptive design in clinical trials
Using an adaptive design for clinical trials can often result in a more efficient, informative and ethical trial over traditional designs. This is often due to the better use of resources and sometimes fewer participants, but what is an adaptive design and what are the advantages of using it in oncology trials? Monica Karpinski speaks to Lillian Siu, senior medical oncologist at the Princess Margaret Cancer Centre and Patrick Wen, MD, director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, to find how adaptive design differs from the traditional fixed design and what CRO and sponsors can expect from this approach.
How much do clinical trials cost?
In the ever changing landscape of clinical trials, markets have increasingly seen associated costs rise over the years with an estimated 140% increase in the past decade. With roughly $2.6bn – and 15 years to bring a new drug to market – what can be done to cut costs and raise efficiency? Andrea Valentino talks to Dawn Anderson, managing director, Deloitte Life Sciences R&D and Salman Shah, R&D consulting field of play leader and principal at EY, to find out how optimised clinical supply sourcing, and the clever use of technology and data, can help keep prices down.