Veeva Systems launches portal new integrations
By Mia Burns
Veeva Systems previewed a new cloud-based investigator portal in late June during the Drug Information Association’s 2013 49th Annual Meeting in Boston, and additionally, announced that three regulatory information management companies will integrate their publishing tools with Veeva’s Vault Submissions application.
The new Veeva Vault Investigator Portal will serve as a companion product to Vault eTMF. Vault Investigator Portal enables fast collection, sharing, and tracking of all investigator content from a single platform. Veeva has specifically designed its new investigator portal to speed study startup by simplifying the overall trial document management process and providing bi-directional, direct access to the eTMF.
“Veeva System’s Vault eTMF and Vault Investigator Portal are both built on a multitenant cloud-based platform and seamlessly integrated in a single system to provide investigators, sponsors and CROs with total visibility,” says Michael Burton, director of product strategy, Vault eTMF. “Documents can be saved in one place, one time and accessed securely by all participants to streamline the entire process. As important, both systems have similar, consumer web-like interfaces so they are intuitive and easy to use for all users.”
“More specifically, Vault eTMF maps out the documents required to complete the eTMF and tracks the status of documents that have been received, approved or remain outstanding,” Burton told R&D Business Pharma Connect. “It proactively alerts investigators of required tasks and their deadlines, and automatically places documents into the right eTMF structure while also allowing for critical quality checks. Vault Investigator Portal, likewise, displays a prioritized to-do list to make regulatory compliance as easy as possible for the investigator sites. The combination saves time and improves accuracy.”
Regarding the bi-directional access that the portal will provide, Burton says, “Bi-directional access refers to how documents flow between the sponsor/CRO and the investigator sites, with each party able to send and receive documents from other parties for greater visibility. This feature enables investigators to see all of the documents they need to consume and those that they've contributed to the trial master file. It also forces proactive content management by allowing the system to push out alerts that keep all participants on task. These alerts are key because they not only make an investigator’s job easier but also improve overall effectiveness and speed study startup.”
As for the publishers who are integrating their tools with the Veeva’s Vault Submissions application--Liquent, a Parexel International company, Extedo, and Lorenz-- life sciences companies can now more easily manage, publish, and submit drug applications to health authorities around the world.
The global network of external partners in drug development has dramatically increased the complexity of regulatory submissions. Sponsors struggle to collaborate with mission critical partners when using traditional on-premise technologies. As an alternative, cloud-based Vault Submissions enables global access and easy collaboration for more efficient submission content production. Now, with integrations to leading publishers, life sciences companies have a more robust cloud option.
“These are the first integrations between regulatory information management companies and Vault Submissions,” says John Lawrie, director of product strategy, Vault Submissions. “Our goal is to fully support sponsors’ effort through the drug development process all the way to healthcare authority approval, which means providing an easy path from content creation through to publishing. We will continue to assess any potential integrations that would support this vision.”
Vault Submissions is built on a modern multitenant cloud architecture for rapid innovation with no software upgrades. As a truly cloud-based solution, Veeva customers can more easily stay current with regulatory changes. In addition, Vault Submissions’ real-time reporting gives companies visibility into submission readiness and missing documents to speed the submission process.
eCTD has been an FDA submission standard since 2003, and the agency plans to release a new 2253 form. Previously, the target date for the new 2253 form was September. “The FDA has re-set timing expectations for the release of the new Module 1 specification, which includes coverage for promotional materials, from September 2013 to June 2014,” Lawrie told R&D Business Pharma Connect. “By integrating Vault Submissions with leading publishing applications in the cloud, Veeva provides life sciences companies with a dramatically streamlined process for the publishing of all regulatory submissions, including the anticipated changes in the upcoming Module 1 update. The integrations eliminate time-consuming steps required to submit by providing a single, securely accessible repository where internal and external collaborators globally interact with regulatory submissions content throughout its entire lifecycle – all the way to the final publishing step of the process. And it’s all happening in a cloud environment where access is convenient from anywhere and from any device.”
Posted: August 2013