news roundup
The FDA has extended its Cooperative Research and Development Agreement (CRADA) with CluePoints to October 2021, and will include additional research focused on "moderators of treatment effect" and real-world evidence. FDA also plans to conduct statistical tests provided by CluePoints such as Key Risk Indicators that will supplement the existing data-driven approach to selecting sites for inspection using a risk-based approach.
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Exclusive Video from DIA:
Watch Ken Light from OmniComm talk about noteworthy changes and innovations that are impacting clinical trials.
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Sponsored by: OmniComm |
CRO CROMSOURCE has further refined its Hybrid Services to provide clients with an efficient alternative to traditional fully outsourced or functional service provider (FSP) models.
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Launching Medical Devices in the Japanese Market
- How to navigate regulatory and reimbursement approval
Thursday, October 31, 2019 at 11am EDT
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Certara has launched Phoenix 8.2, its pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation software for drug development. Updated features include access to PK Submit and Certara Integral directly using Phoenix plug-ins, the Reporter Tool has added several updates and the Phoenix Online Help section has been modernized.
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Begin with the End in Mind: The Strategic Benefit of Coordinating Site Budgeting, Contracting, & Payments
Wednesday, October 2, 2019 at 11am EDT
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The Veteran's Administration leadership is committed to changing its clinical research processes to become more competitive to industry opportunities, and in July presented its updates to Congress.
Articles
Varied site performance, increasing staff workloads, limited access to data analytics, and difficulty finding patients, has resulted in a clinical site landscape that is looking to become more competitive, as well as flexible, collaborative, customized, and efficient for the clinical research enterprise.
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How AI/ML and advanced techniques are enhancing clinical development
Lessons learned from use in study design, patient and site ID, safety, and risk-based monitoring
Tuesday, October 1, 2019 at 11am EDT
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Patient retention is an important element of the Parkinson's Progression Markers Initiative (PPMI), a landmark, longitudinal, observational study sponsored by The Michael J. Fox Foundation (MJFF). This article discusses their strategies to retain participants in detail.
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Successful Early Phase Drug Development of mAb Drugs
Europe: Thursday, September 26, 2019 at 3pm BST | 4pm CEST
North America: Thursday, October 3, 2019 at 11am EDT | 10am CDT | 8am PDT
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Blog Posts
Stella Kyriakides is named to European Union Health Commissioner and is tasked "to support the health sector and the professionals working within it, to invest in new technologies, to promote healthy lifestyles and to cooperate better within the EU."
In this interview, Dr. Steven Fox, CEO of Akelos, Inc., discusses the environment of non-opioid drug options, and challenges of developing new non-opioid medical products.
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