October 2013

PharmaVigilant releases I-Vault3

Thursday, October 24, 2013

PharmaVigilant, an e-clinical provider, has released the I-Vault3. I-Vault3 features new Cube technology, a powerful, multidimensional solution that allows for every document, image and video from an organization to be digitally stored in I-Vault3 with the highest security, access and control in the industry.

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IDDI simplifies collaboration, switches to Veeva Systems’ Vault eTMF Solution

Wednesday, October 23, 2013

International Drug Development Institute (IDDI), an international functional CRO headquartered in Belgium, replaced its mix of a paper-based trial master file (TMF) and e-rooms with Veeva Systems’ cloud-based Vault eTMF solution, part of Veeva’s Development Suite. As a CRO that collects, analyses and reports all data from international phase I through IV clinical trials for sponsors throughout the U.S., Europe and Asia, IDDI wanted a single, centralized system to streamline auditing and collaboration. After evaluating five systems, IDDI chose Vault eTMF for its document tracking capabilities and globally accessible cloud platform.

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ACPU adds new corporate membership class, partners with HealthCarePoint

Wednesday, October 23, 2013

During the opening session of the Association of Clinical Pharmacology Units (ACPU) annual meeting, Donna Dorozinsky, ACPU president, announced the creation of a new corporate membership class. For the first time, Clinical Pharmacology Units (CPUs) can join ACPU directly. Dorozinsky also announced a strategic partnership with HealthCarePoint to provide new corporate members with access to HealthCarePoint’s buying club and PET-ABC (HR management software) in addition to discounted access to HealthCarePoint’s TrainingCampus eLearning system.

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Amarin to eliminate 50% of staff following FDA Advisory Committee vote

Wednesday, October 23, 2013

Amarin, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, plans to reduce operating expenses by eliminating approximately 50% of its staff worldwide, following the recent recommendation of the FDA Endocrinologic and Metabolic Drugs Advisory Committee against the potential Vascepa (icosapent ethyl) label expansion.

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