TransCelerate BioPharma Inc.
Latest From TransCelerate BioPharma Inc.
Digitizing data collection and monitoring has taken longer than desired due to various challenges, including resistance to change, unanticipated burdens and trial complexity, officials from ACRO and Medidata say, countering US FDA Commissioner Gottlieb’s criticisms that CRO business practices are holding back change.
Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.
Goal is to streamline preclinical development through cross-company sharing of target-based toxicology datasets.
Industry says relaxation of HIPPA could take years off drug research and enable new clinical trial networks, but is less willing to de-privatize its own data.
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