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Applied Clinical Trials
PLEASANTON, CA – Jan. 22, 2015– To improve visibility, control, and collaboration for its ongoing and planned clinical trials, San Diego-based biotech Conatus Pharmaceuticals selected Veeva Vault eTMF and Veeva Vault QualityDocs – cloud applications for the management of clinical study and quality and development documentation, respectively. As Conatus expanded its network of external partners across a growing number of sites worldwide, it sought a paperless solution to reduce costs and provide an efficient way for all parties – including a largely mobile clinical workforce – to access content. With Vault eTMF and Vault QualityDocs, Conatus has gained a single, authoritative source for verified, current documents, streamlining information-sharing across the enterprise.
Conatus had been using a hybrid of paper and electronic document management processes to support the clinical study of its first-in-class compound, Emricasan, but wanted to increase efficiency and improve collaboration across all stakeholders globally. In addition, Conatus wanted an advanced, industry-specific system and to free internal staff to refocus on core competencies. With Vault’s multitenant cloud infrastructure, Conatus will no longer be sidetracked by system maintenance – Vault applications provide key life sciences functionality without the need for heavy customization. In addition, because Vault eTMF and Vault QualityDocs are delivered in the cloud, Conatus gains automatic access to continuous innovation – eliminating lengthy, manual system upgrade projects.
“To increase efficiency and enable our teams to focus on our core business, we wanted to outsource our key business applications – that’s what led us to Veeva. Easily configured to our specifications and continually updated, Vault ensures we are always working with the latest and most relevant technology without a large infrastructure investment or time drain,” remarked Conatus CEO Steve Mento. “Our priority is developing drugs – not managing paper or upgrading technology. Vault helps us move faster and improve effectiveness by allowing us to collaborate easily, maintain the control we need in a regulated environment, and improve visibility. Real-time reporting capabilities give us immediate insight into where content stands, so we can address bottlenecks quickly and improve our processes on an ongoing basis.”
Since its inception, Conatus has made efficiency a guiding principle in order to concentrate its resources on research and development. Vault eTMF aligns with Conatus’ corporate mission by eliminating inefficient and labor-intensive paper-based processes to simplify trial document exchange. Early results indicate that Conatus is also in step with recent research that shows companies using advanced eTMF technologies experience significant benefits such as improved collaboration, inspection-readiness, visibility, and cost savings. And as Vault eTMF is built according to the DIA TMF Reference Model, Conatus now has a repeatable framework that follows international standards. “Having a system built according to the standards of the DIA TMF Reference Model was important to us, especially considering the scope and complexity of our clinical development activities,” added Mento. “Veeva has the foresight to build a solution that reflects widely recognized specifications.”
Conatus Vice President for Regulatory and Quality Cindy Luchetti added, “Our previous system was not ideal for clinical trial records. Vault eTMF gives us optimized capabilities with the added bonus of the DIA TMF Reference Model. Now, we are completely paperless, using electronic signatures for almost everything and recording all approvals in the system. This kind of efficiency is critical to meeting our research and development goals.”
Vault QualityDocs has also proven key to supporting Conatus’ efficiency goals by delivering a single, global source of all quality system documents, manufacturing records, development reports, and validation documents across the enterprise. An approved document is uploaded once and shared to all globally – eliminating the risk and inefficiency of unsecured paper copies. In addition, Vault QualityDocs’ Read and Understood functionality allows Conatus team members to review documents easily and management to monitor completion using simple dashboards.
“Vault QualityDocs has made immediate impact on our operational efficiency and compliance,” added Luchetti. “Our staff always has access to the current effective version of a document anywhere with web access – whether in the office or on the road. It’s faster. It’s easier. And it encourages them to follow our procedures. We also automatically track who is reading or has been trained on which materials for simplified compliance reporting.”
Vault QualityDocs and Vault eTMF, along with all Vault applications, are designed to closely mirror familiar consumer web sites, providing an intuitive interface for all users. “Vault is sleek and simple. Our employees, and various external partners have picked it up without a steep learning curve and only minimal training – literally just an hour or two,” noted Mento. “Vault simplicity not only makes us more efficient and it easier to share information, but it also encourages all users to leverage the full functionality of the system for greater return on investment.”