In the rare disease issue of New Medicines, Novel Insights from Parexel, experts and former regulators share insights for developing effective regulatory strategies earlier.
Current industry trends align with the need for improved, fit for purpose technology.
Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power, are transforming today’s clinical research.
Master protocols helped accelerate research during the pandemic in the EU. How can US companies learn from this and start preparing master protocols now?
The approach of the Cancer Research UK Centre for Drug Development.
Exploring the 11 key ‘warning signs’ that could impact partnership success.
In a complex world of global clinical trials where execution is riddled with uncertainty, how should sponsors and providers approach and achieve a balance of risk and reward?
Phase I/II study in cancer patients showcases eClinical effectiveness.
Fully-integrated, component-based CDMS offers flexibility, customization, and efficiency.
The use of modeling and biosimulation can help predict potential outcomes and improve confidence in therapeutic candidates for Alzheimer disease.
The many different shapes and sizes of vendors requires a thoughtful process for selection.
Key considerations in deploying fit-for-purpose digital health technologies in drug development.
Pursuing new tools and capabilities in sample logistics, storage, and data analysis.
Emerging tools in data analytics, automation, EMR aggregation, and even social media are enabling faster and easier patient recruitment.
The adaptability and innovative capacity of CROs highlighted in EUCROF survey.
A well-designed approach can benefit clinical trials from protocol design to site support.
Bringing clinical trials to patients’ homes can address existing site-based challenges.
The ongoing evolution of real-world evidence from a novel concept to a cornerstone of modern medical research signifies its growing importance and vast potential to improve personalized medicine, overall healthcare outcomes, and eventually democratization of scientific facts by general accessibility.
Harnessing advances in digital health technologies for a more precision-measured approach.
AliveCor knows that cardiac safety is critical, with concerns often driving drug withdrawals from trials and the market. Our solutions go beyond compliance to boost regulatory trust, data integrity, and trial success. As the only company offering integrated 6L and 12L ECGs, we provide comprehensive monitoring—onsite and remotely—to meet complex cardiac requirements. Our innovative tools empower sponsors and CROs to control trial data, enabling faster, smarter decisions throughout the research lifecycle.
In the ever-evolving landscape of healthcare, it's vital for organizations to take steps toward bridging the gap between their clinical and marketing teams.
Statistical methods used via this technique in centralized monitoring.
Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
Study evaluates the use of AI-supported medical coding module.
Similar to a world-class symphony, a curated site start-up model can accentuate its individual components and lead to swift starts for clinical trials.
Leveraging and benchmarking insights to boost efficiency and optimization.