Managing Regulated Life Sciences Content with Medidata and Box
Location: New York, NY
Use Case: Secure management of regulated life sciences content
Medidata is reinventing global drug and medical device development by creating industry-leading, cloud-based solutions for clinical research. Through advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of over 850 pharmaceutical, biotech, diagnostic, and medical device companies world-wide. They also serve leading academic medical centers and contract research organizations. Their flagship product, Medidata Clinical Cloud®, is the primary technology powering clinical trials for 18 of the world’s top 25 global pharmaceutical companies, and is used by 18 of the top 25 medical device developers. It encompasses study design and planning through execution, management, and reporting.
Zosano Pharmaceuticals approached Medidata to help them implement a new content management system to manage their regulated content. They had already been using Box for their non-regulated content, and were looking for a solution that integrated easily with their Box instance, as well as offered a great user experience, simple implementation, and pre-built functionality. “Using Medidata was easy from a validation standpoint, because it was delivered to us ready to use,” said Hayley Lewis, VP of regulatory and compliance at Zosano.
Zosano implemented the Medidata Regulated Content Management (RCM)TM which worked seamlessly with their existing Box infrastructure. “Medidata RCM was the choice for us because the intuitive interface integrates quite well with our Box platform,” said Hayley Lewis. “There was no additional training we had to give our users as they were already familiar with the platform interface.”
Medidata RCM is a highly secure, validated, 21 CFR Part 11 compliant, cloud-based content management collaboration platform. It includes applications (such as SOP management and eTMF) that enable storing, reviewing, approving, and retrieving regulated content. Medidata RCM empowers everyone — sponsors, sites, CROs — to seamlessly manage regulated content and actively maintain inspection readiness.
Because Medidata RCM integrates with Box, it allows users to create, store, view, edit and jointly collaborate on both regulated and non-regulated content in a single application with cutting-edge UX capabilities.
Medidata chose to partner with Box because of Box’s deep content management expertise, market leadership, and broad base of customers within the life sciences industry. By integrating Medidata RCM with Box, the company can offer their customers a single repository to manage all of their life sciences content, data, and workflows, helping them eliminate system silos and costly integrations. In addition, customers can access regulated and non-regulated content via their mobile device, all while maintaining security and compliance.