Amgen has entered a partnership to use Veeva Systems’ comprehensive Clinical Platform to enhance trial processes.
This collaboration also aims to advance innovation in clinical trials and expedite the development of new treatments for patients with serious illnesses.
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Veeva Systems will provide Amgen with a connected platform that spans various data applications and clinical operations.
It includes tools for clinical trial management systems (CTMS), electronic data capture (EDC), and electronic trial master file (eTMF) applications, among others.
Amgen chief information officer and senior vice-president Scott Skellenger said: “In collaboration with Veeva, we’re leveraging advanced technology to unlock new capabilities for our end-to-end trial operations, which are expected to further strengthen our ability to bring innovative treatments to patients with speed and scale.”
The CTMS offered by Veeva is designed to manage and monitor clinical studies, supporting both insourced and outsourced studies.
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By GlobalDataIn addition, the EDC system facilitates the collection, review, and management of patient data reported by clinical sites.
The eTMF system is essential for maintaining the quality and timeliness of trial master files. It also supports global outsourcing and features a TMF Transfer function to streamline the exchange of completed TMFs between contract research organisations (CROs) and sponsors at the close of a trial.
Veeva’s electronic clinical outcome assessments (eCOA) enable questionnaire responses to be captured directly from subjects, clinicians, or caregivers through digital means.
CROs, sponsors, and clinical trial sites use the Randomisation and Trial Supply Management (RTSM) component of the platform to randomise participants and manage the study supplies.
Veeva Business Consulting will assist Amgen with the implementation and change management.
Veeva development cloud president Jim Reilly stated: “We’re excited to help Amgen further advance clinical development. Veeva Clinical Platform will provide the backbone for standard and connected processes that can speed the delivery of life-saving drugs to patients in need.”
