news roundup
iCardiac Technologies has been selected to work on an early phase oncology clinical trial with a Japanese pharmaceutical company. The study will utilize its iCardiac's Rapid QT service offering, to enable trial sites to make more accurate patient inclusion/exclusion decisions.
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Coming to terms with Patient Centricity
Live Webinar: Tuesday, June 20 at 12:00pm EDT  Register now |
Italy-based CRO Exom Group has announced the launch of its electronic informed consent solution, Genius Engage. The tool's digital workflow is fully combined with the eTMF, and integrated with the eCRF.
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Selecting and Auditing a Technology Vendor for Biopharmaceutical Development
Live Webcast: Thursday, June 8 at 11:00am EDT
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Modernizing FDA's new drug regulatory program is a main goal for Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), she said at the DIA/FDA annual Statistics Forum in Bethesda, MD.
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Emerging Biopharma and Rare Disease: Finding a Needle in a Haystack
Data-driven Patient Recruitment Solutions
Live Webinar: Thursday, June 8 at 2:00pm EDT
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Latest business and people news from the clinical trials industry.
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Achieve Better Outcomes with New RBM Tech Enhancements
Live Webinar: Wednesday, June 7 at 11:00am EDT
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Articles
This article outlines a decision-making framework that integrates real-world signals with supply planning techniques to proactively reduce supply chain risk and avoid potential supply interruptions developed by the clinical drug supply team at Biogen and Brizzey, a clinical supply chain management company.
Sponsors who already have experience with FSP should evaluate what aspects are working and which are not, as there may be a better model available.
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Is Your CTMS Working for You? Unify and Optimize Your Approach to Clinical Trials
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Talking the Patients' Language – the importance of effective, patient-centered engagement
Live Webinar: Tuesday, June 6 at 8:00am EDT  Register now |
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Winning the RAT race: A new Center of Excellence to drive development of regenerative medicines
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Blog Posts
The initiative highlights some of the gaps in the European provision of novel therapies in general, and immunotherapies in particular, especially the patchwork-quilt character of Europe's drug market.
An interview with Joyce Smith, Clinical Country Lead & Research Nurse Manager at The Medical Research Network, a clinical research nursing provider, highlights the study site's perspective on data quality.
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Risk-Based Monitoring
A graphical tool—subject profile analyzing risk (SPAR)—is a proprietary tool designed to align with the FDA, EMA and ICH guidance documents on RBM and eSource. This article discusses its use in a PaxVax Phase IV trial implementing risk-based monitoring (RBM).
CluePoints has added Patient Profile reports to its Risk-Based Monitoring and Data Quality Oversight solution.
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