Veeva Systems has introduced Veeva Vault EDC and Veeva Vault eSource, the first applications for clinical data management on a single cloud platform. Together with Vault CTMS, Vault eTMF, and Vault Study Startup, Veeva is expanding the Veeva Vault Clinical Suite, the industry’s only suite of unified cloud applications to streamline clinical operations and data management, from study startup to archive.
In less than four years, Veeva has added more than 120 clinical operations customers, including global deployments of Veeva Vault eTMF at seven of the top 20 pharma companies. Veeva is building upon its track record of innovation and customer success by delivering a modern cloud approach for clinical data management with Vault EDC and Vault eSource. Now life sciences companies will get the high quality data they need faster to accelerate trials.
Since 2000, the volume of data in a phase III study has risen by more than 50% and the cost per patient for a clinical trial has almost doubled. Traditional electronic data capture (EDC) systems add to this complexity and cost by requiring site staff to spend a significant amount of time managing clinical data. System setup, maintenance, inflexibility, and a lack of integration have slowed down the pharmaceutical industry’s ability to get clean data and quickly make informed, confident decisions during trials.
“The drug development process is fraught with delays and inefficiencies due in large part to protocol complexity, operating fragmentation, and the use of disparate point solutions,” said Ken Getz, associate professor and director at Tufts University School of Medicine. “The integration of clinical practice and clinical research data, next generation eClinical technology solutions that unify end-to-end clinical processes, and improvements in protocol design execution feasibility will all be critical success factors in driving higher levels of efficiency, performance, and data quality.”
Vault EDC will be a modern and adaptive cloud application and purpose-built for trial processes to speed critical workflows and enable real-time feedback. It will provide an intuitive, consumer-friendly experience for sites, sponsors, and CROs to quickly and easily access data, and be a single point of focus for clinical data and facilitate all trial designs, from the simplest to the most complex.
Customers can deploy Vault EDC as a standalone application or integrate electronic source data (eSource) with Vault eSource to record patient data directly into an easy-to-use mobile application. This will not only eliminate the need to manually transcribe patient data into an EDC system—which can be days or weeks after the patient visit—but will also cut costly and time-consuming onsite source data verification by clinical monitors.
Vault EDC and Vault eSource will be built upon an open cloud architecture that allows them to be used with other third-party clinical systems. When used together, Veeva will offer the first and only integrated solution on a single platform to ensure high quality data at the point of entry in eSource all the way through to the EDC system, helping streamline clinical processes and speed product time-to-market.
“The industry has been forced to settle for clinical data management systems that have been short on innovation and high on complexity,” said Henry Levy, chief strategy officer at Veeva Systems. “Vault EDC and Vault eSource will offer an innovative, integrated approach that will deliver the data quality and real-time access that is needed to make faster, informed decisions and cut the cost and complexity of trials.”
Today’s news signals Veeva’s focus and investment in this important market—which is estimated to be $1 billion globally for EDC alone—to manage clinical data more efficiently and effectively. The expense impact of this new initiative was reflected in the company’s guidance for fiscal year 2017.
The Veeva Vault Clinical Suite will now include Vault EDC and Vault eSource along with Vault CTMS, Vault eTMF, and Vault Study Startup to become the most comprehensive suite of clinical cloud applications on a single platform. For the first time, life sciences companies can unify clinical operations and data management to streamline end-to-end processes.