PMDA

Kyowa Hakko Kirin joins Certara’s Simcyp consortium

Wednesday, September 13, 2017

Certara, a provider of model-informed drug development and regulatory science, announced that Kyowa Hakko Kirin has joined the Simcyp Consortium and licensed the Simcyp Population-based Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical company and the 11th Japanese pharmaceutical company to join the Consortium. Member companies meet in a pre-competitive environment and work together to progress the evolution of modeling and simulation (M&S) and the Simcyp Simulator.

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Certara launches Simcyp Access to expand simulator availability

Thursday, March 9, 2017

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced the launch of Simcyp Access. This new cloud-based licensing approach provides trained individuals at smaller pharmaceutical companies (less than 500 employees) with a method for using Certara’s Simcyp Population-based Simulator in research projects. 

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Aptiv Solutions enables first surrogate endpoint-based adaptive clinical trials

Friday, March 21, 2014

Aptiv Solutions, a global biopharmaceutical and medical device development services company, has released ADDPLAN 6.1, the first statistical software to enable the use of surrogate endpoints to expedite interim analysis decisions in adaptive clinical trials. With this tool, survival trials for cancer therapeutics and other trials with long-duration endpoints can now utilize adaptive designs to a far greater extent.

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