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

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.

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.