news roundup
The Research to Accelerate Cures and Equity for Children Act (RACE) goes into effect August 18, amending the existing Pediatric Research Equity Act to allow pediatric evaluation of new drugs and biologics intended for the treatment of adult cancers.
AG Mednet, a technology company for clinical trials, is launching Judi // Monitor to address review and verification of subject data at the site. It includes the following features, security and compliance; deployment and data access control; source data reviews tools and PHI management.
ERT and Inofab Health have entered into a partnership for in-home spirometry use. The solution enables at-home, patient-administered testing of the lung, for high-quality, in-home data collection for respiratory trials.
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Harnessing CAR-T Therapy for Hematologic Malignancies and Solid Tumors: Experience from City of Hope
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CluePoints announced the launch of its new business intelligence platform, BEYOND, an extended visualization solution and analytics tool for data quality, integrity and risk detection.
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This article includes information and approaches about home visits for sponsors and sites that are considering changing protocols for existing clinical trials and for those interested in including home visits in any new clinical trials.
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Trends In Clinical Trial Planning
Wednesday, July 15, 2020 at 11am EDT | 8am PDT| 4pm BST | 5pm CEST
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Brand Insights - Thought Leadership | Almac
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While most companies have bought into CDISC standards, are using them in ongoing trials, and are transforming legacy data to a compliant format, the authors layout the reasons why companies should consider the standards much earlier in the typical trial planning and design process to fully exploit their use.
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Accelerate your Clinical Trial by Adopting a New Mindset
Wednesday, July 22, 2020 at 10am EDT | 9am CDT | 3pm BST | 4pm BST
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Blog Posts
The FDA recently released guidance on ways to consider and manage changes in statistical methods for quantifying uncertainty generated by the pandemic. This is just the latest in a steady wave of new advisories from the FDA on strategies for modifying practices for treating and tracking patients in clinical trials in the ongoing pandemic.
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A recently announced EU program, EU4Health, aims to deliver support to clinical trials—not just because of the contribution they can make "to the rapid development of medical countermeasures…in the time of health crisis emergency", but also to address unmet medical needs and speed up "the development, authorization, and access to innovative and effective medicines." It also addresses shortages of medicines currently being experienced because of the pandemic.
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Are the Intended Benefits of ICH Regulations Obscured by the Adoption Struggle?
Tuesday, August 25, 2020 1pm EDT | 12pm CDT | 10am PDT
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