In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
|Articles|June 19, 2017
Cognizant Announces Collaboration with TransCelerate BioPharma Inc.
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Cognizant, in its collaboration with TransCelerate BioPharma Inc.-a non-profit organization containing members of global biopharmaceutical companies-announced its new Shared Investigator Platform (SIP) for clinical trial researchers. The platform is cloud-based and will help researchers access, share, and anayze data for the biopharmaceutical industry.
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Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.
A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.
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In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
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