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IDDI Improves Collaboration, Control, and Audit-readiness in the Cloud with Veeva Vault eTMF
技术
- 平台即服务 (PaaS) - 数据管理平台
适用行业
- 药品
- 医疗保健和医院
适用功能
- 产品研发
- 质量保证
用例
- 远程协作
- 监管合规监控
服务
- 云规划/设计/实施服务
挑战
Before moving to Veeva Vault eTMF, IDDI was burdened with a cumbersome hybrid system of paper-based processes supplemented with electronic shared drives and e-rooms for sharing documents with its clients. Users turned to unsecured workarounds like email, and the complexity prevented effective collaboration with sponsors, independent data monitoring committees (IDMCs), and internal teams around the world. Paper documents proved too difficult to access and track, and the organization turned to shared drives to give sponsors access to content electronically. However, these shared drives were only accessible off-site by using a VPN. E-rooms were meant to provide more flexibility, but limitations in the e-room access control model created a new set of challenges and security vulnerabilities, leading to serious compliance concerns. Lacking true content management capabilities like workflow, reporting, and audit trails, these file shares functioned largely as document storage, and had to be cleared periodically to make room for new documents. Facing an impending audit, IDDI decided to print all electronic documents to create a paper-based TMF. Despite the time and effort expended to compile trial master f ile (TMF) documents from disparate sources, audit-readiness remained challenging.
关于客户
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology. IDDI optimizes the clinical development of drugs, biologics, and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston, Raleigh, and Cupertino. The organization is committed to providing the highest quality of services, exceeding customer expectations, and ensuring patient safety. IDDI's mission is to provide accurate, timely, and cost-effective services that are tailored to the specific needs of each client. The organization's team of experienced professionals is dedicated to delivering innovative solutions that meet the unique needs of each project, from early phase to post-marketing studies.
解决方案
IDDI searched for two years and reviewed six solutions before selecting Vault eTMF for its combination of cloud fl exibility and life sciences-specifi c capabilities that met their most strategic areas. Crucially, as a process-driven application delivered in the cloud, Vault eTMF enables real-time collaboration between all trial stakeholders, and ensures IDDI’s clients can always access the most recent versions of study documents. All users, wherever they are in the world, can review and contribute eTMF documents via a simple web login, eliminating the need for VPNs and layers of permissions. Along with simplifying communication, Vault eTMF’s document metadata allows content to be shared across studies for the same sponsor – helping IDDI better meet client needs. E-signatures in Vault eTMF have also removed the costly and time-consuming process of shipping paper documents for client approval. With Vault eTMF, IDDI was able to streamline processes that had previously been labor and resource-intensive and close gaps that had introduced compliance risk.
运营影响
数量效益
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