Risk-based quality management depends on knowing what to monitor and on interpreting what the signals mean.
|Articles|November 30, 2015
Infinity To Use Medidata RBM in Phase III Oncology Study
Infinity Pharmaceuticals will use Medidata's RBM solution in an upcoming Phase III oncology study for patients with indolent non-Hodgkin lymphoma.
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Infinity Pharmaceuticals has expanded its use of the Medidata Clinical Cloud®, by utilizing its risk-based monitoring (RBM) solution in an upcoming Phase III oncology study for patients with indolent non-Hodgkin lymphoma.
Infinity has been a Medidata customer since 2005, utilizing the company’s cloud-based technology for electronic data capture and management (Medidata Rave®) and medical coding (Medidata Coder®) across its pre-clinical and Phase I-III development programs. To further advance its drug development strategy and outsourcing model, Infinity is leveraging the combination of technology and analytics within Medidata RBM-including centralized statistical analytics, targeted source document verification (TSDV), and study and site level key risk indicators (KRIs).
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In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.
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