实例探究 > Kythera Chooses Veeva Vault to Manage Regulated Content Enterprise-wide and Shaves TMF Reconciliation Time by 40%

Kythera Chooses Veeva Vault to Manage Regulated Content Enterprise-wide and Shaves TMF Reconciliation Time by 40%

公司规模

Mid-size Company

地区

America

国家

United States

产品

Veeva Vault eTMF
Veeva Vault QualityDocs
Veeva Vault MedComms

技术栈

Cloud-based applications
Electronic Document Management

实施规模

Enterprise-wide Deployment

影响指标

Productivity Improvements
Cost Savings

技术

平台即服务 (PaaS) - 数据管理平台

适用行业

药品

适用功能

产品研发
质量保证

服务

云规划/设计/实施服务

关于客户

Kythera is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel prescription products for the aesthetic medicine market. The company’s objective is to develop prescription products using an approach that relies on the scientific rigor of biotechnology to address unmet needs in a rapidly growing market. Kythera’s initial focus is on facial aesthetics – the market’s largest segment. The company‘s drug for the reduction of sub-mental fat is currently in late-stage clinical development.

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挑战

Kythera, a clinical-stage biopharmaceutical company, was facing challenges in managing clinical documents and facilitating business processes for the development of its newest product candidate. The company had 26 studies already on file along with four active clinical studies, resulting in thousands of documents to share, manage, and store. Kythera had been using a patchwork of different document repositories and systems for each functional area, including a file share system for TMF documents and a SharePoint-based system that was difficult to access and use for internal collaborators and external partners. Multiple versions of documents changed hands with no reliable document accountability. The resulting errors slowed study processes and added risk. Exchanging documents by couriers internationally only added to the inefficiency. Kythera’s legacy system was also extremely difficult to manage and update. Without the luxury of a large internal IT team, Kythera required a turnkey system that integrated clinical, regulatory, and medical affairs document management and didn’t require dozens of staff to implement and maintain.

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解决方案

Kythera chose Veeva’s Vault suite of cloud-based applications to connect its teams from clinical to commercial. Initially, Kythera rolled out Veeva Vault eTMF to manage all of its trial documents and support global collaboration between sponsors, CROs, sites, and investigators with its integrated Investigator Portal. Kythera is also leveraging Veeva Vault QualityDocs to establish a single source of truth for all quality documents, and Veeva Vault MedComms to simplify the global coordination of medical communications. Kythera has established Vault eTMF as its central hub for exchanging documents with CROs, investigator sites, and other clinical partners. Each exchange is tracked by Vault and available via real-time reports that provide visibility into trial status and TMF completeness. The resulting data also provides actionable insights that allow Kythera to proactively improve study processes.

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运营影响

Improved Workflow: Vault delivers total electronic access to documents that were previously transmitted as email attachments or as paper copies via courier. This has improved workflows throughout the trial process.
Electronic Signature Capture: Kythera can now capture electronic signatures and is building new SOPs to take full advantage of this time-saving convenience.
Timely eTMF Reports: Vault eTMF allows Kythera to run a full range of standard and ad hoc reports effortlessly, giving the company a view into trial progress and enabling better management of the study.

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数量效益