The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|August 30, 2011
OptiNose Standardizes on Medidata Rave Clinical Technology
Advertisement
“The company’s selection of Rave speaks volumes about the comfort and trust in our technologies at all levels–from sponsors of all sizes to investigators across the globe.”
Founded in 2000, OptiNose is focused on the development of breakthrough bi-directional nasal drug delivery technology which significantly improves drug transport to targeted sites deep into the nasal cavity. The company is currently planning clinical research programs for the treatment of migraine headaches, nasal polyposis and chronic sinusitis. In assessing potential systems, OptiNose looked for a user-friendly, affordable EDC system that could potentially reduce time to database lock across global trials.
“The product’s ease-of-use and the company’s global presence provide benefits for our clinical development team, as well as our investigators, many of whom are familiar with the Medidata system,” commented Jennifer Carothers, senior director of clinical development, OptiNose.
Leveraging Medidata Rave’s global library to create standard electronic case report forms (eCRFs) will help OptiNose accelerate EDC set-up across their trials. Research teams, including site investigators, will also benefit from Rave’s broad data reporting capabilities, including out of the box J-Review reports for simplified ad-hoc clinical data analysis.
Advertisement
Related to this article
Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.
In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, argues that CROs must act as orchestrators rather than aggregators—and that the real test of any AI ecosystem is whether it reduces sponsor coordination burden or just hands it back to them.
Syneos Health and Optum outline a joint model for trial planning, recruitment and site access, with no financial terms or timelines disclosed.
AstraZeneca and Oracle Outline AI Collaboration for Clinical Trial Recruitment and Safety Monitoring
What sponsors and sites should know about the AstraZeneca-Oracle AI collaboration on trial recruitment, safety monitoring and data governance.
Advertisement
Advertisement
Trending on Applied Clinical Trials Online
1
Where the Industry Is Headed as Clinical, Operational, and Real-World Data Connect
2
Building Standardized Evidence for eSource-Enabled Clinical Trials: Multi-Site Validation of a Clinical Research Coordinator Satisfaction Methodology
3
Where AI Governance in Clinical Development Falls Short
4
Syneos Health, Optum Partner on Adaptive Clinical Development Model
5