Case Study

Solution Delivers Compliance Assurance To An Emerging Pharmaceutical Company's Quality & Regulatory Team

Solution Delivers Compliance Assurance To An Emerging Pharmaceutical Company's Quality & Regulatory Team

Zosano Pharma, an emerging pharmaceutical company focused on the central nervous system, faced a challenge many life sciences companies experience: it needed a unified system and process to enable users to access regulated and non-regulated content.

The company had been using a file server system with folders containing PDF documents that needed to be tracked and traced manually. Zosano turned to Medidata to help it deal with its resource-intensive processes.

Medidata RCM, which was deployed in just six weeks, provides Zosano Pharma with a unified solution for standard operating procedure (SOP) management, for both regulated and non-regulated content, that is cost-effective and quickly deployable. The solution provides Zosano with tools for workflow management that help create, edit, and approve content with read and acknowledge capabilities, including reviewing documents via mobile platforms. Zosano introduced iPads equipped with Medidata RCM to their manufacturing area to facilitate training and familiarization with and access to SOPs.

Since Medidata RCM is fully integrated with Box, the leading enterprise content management platform, users can search both platforms for regulated and non-regulated content in one pass. An intuitive interface meant there was no need for additional training. Users can now search for all regulated and non-regulated content from one place, and review and approve content from anywhere, anytime with mobile accessibility.

The adoption of Medidata RCM has led to increased compliance and familiarity with documentation, and fewer regulatory risks. In addition, because users no longer waste time tracking down and indexing documents, productivity has increased allowing regulatory teams to focus on innovation and accelerated time to commercialization.

About Medidata
Medidata is reinventing global drug and medical device development by creating the industry’s leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including more than 850 global pharmaceutical companies, innovative biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.

The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution 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—from study design and planning through execution, management and reporting.