“Effective, knowledgeable and accessible.”
"Instead of a passive approach to managing clinical trial documents, where we file them days after their collection and complete QC at the end of a study, we can now take an active approach in which we enter documents into Veeva Vault eTMF and QC them continuously throughout the trial."
“We are shaving at least 40% off the time needed to reconcile TMF documents at the conclusion of a trial with our Vault eTMF cloud system. Now, we have full visibility and can track the status of the TMF in real time for the entire duration of the study.”
“SCRS applauds Veeva’s site-centric approach. There is a significant opportunity for solution providers to include sites’ perspectives when designing technology. When technology solutions reflect site needs, they are more effective in achieving their goal to streamline workflow processes.”
“Veeva Vault CTMS breaks down application and process silos and enables us to achieve new levels of efficiency and transparency across our trials.”
“The easy to use interface of Veeva Vault CTMS simplifies clinical trial management for the team, while the ability to bring together CTMS and eTMF allows us to streamline our clinical processes in the cloud."
"Vault makes us more productive by giving us the ability to use iPads and other mobile devices to securely access controlled documents in the cloud from any place."
"Veeva QualityOne is essential to our strategy of making quality and innovation two key pillars of the company. We will have greater flexibility in maintaining quality and drive greater efficiency in product development."
"Veeva has demonstrated its broad range of capabilities in the highly regulated pharmaceutical industry over the past 10 years. The company’s reputation, proven cloud solutions, and commitment to meeting our industry requirements were important factors in our decision to select Veeva. Veeva will help us unify people, processes, and data across the organization."
“We had two main challenges with the project,” said Nuno Galante Valério, Quality Strategy Lead – Digital Quality, RDQ at Merck KGaA, Darmstadt, Germany. “Fully integrating risk management into the overall quality system was a relatively new approach. And the team would have to merge two complex independent management processes in only eight months. But we knew we were breaking new ground and it would have high impact.”
“This approach enabled us to identify and reduce potential failures, We are now analyzing risks, potential root causes, and categorizing them based on the root causes and reasons for failure."
"This forward-looking strategy is going to make our Veeva RIM investment an asset for regulatory and other parts of the company."
“We use Vault reports to perform preinspection quality control (QC). The ability to generate a report showing all unblinded study documents enables us to quickly review content and minimize stress.”
"With detailed guidance for each Vault Safety release, it is easier to apply new software updates and maintain a validated system."
"With Vault Safety, both G1 and the CRO vendor have greater visibility and greater access to the data."