Veeva Vault balances global harmonization with local autonomy for regions, departments, therapeutic areas
Veeva Systems introduces a breakthrough in regulated content management for life sciences with recent Veeva Vault innovations. Vault now delivers a single source of truth across the enterprise, uniting teams from research and development through commercial, to enable global harmonization. Individuals across the organization can share and reuse approved content, eliminating manual hand-offs and duplicate work. At the same time, Vault provides local autonomy and flexibility for each department or region to manage its own content to reflect its unique business processes. Vault maintains one authoritative source document in the cloud to bridge content gaps, increasing efficiency, visibility, and compliance.
This new Vault release brings the global life sciences organization together, including therapeutic areas, regional affiliates, investigator sites, and sales and marketing groups worldwide, which were historically served by separate solutions that didn’t interoperate. Most life sciences companies continue to struggle managing multiple, isolated legacy systems – resulting in manual document handoffs, gross inefficiencies, and compliance risk. Conservative estimates show these inefficiencies contribute to an average of 21% loss in productivity.1
“A simple protocol change in today’s siloed environment may involve more than 25 steps, leveraging multiple copies of a document across multiple systems,” explained Jennifer Goldsmith, vice president of Veeva Vault. “With Vault, we decrease this to one single source, just eight steps, cutting the time required to execute the update from weeks to minutes to dramatically reduce cost and compliance risk.”
One Document, Multiple Uses – Enterprise-wide Harmonization
Today, documents are cross-linked across Vault applications, so the same content is used in a different context – whether in a submission, trial master file, or promotional piece – making the document easier to organize and access for different users but traceable to ensure a controlled, single source of truth. For example, a protocol may be authored by the regulatory team, incorporated into a clinical trial master file, and then distributed to investigator sites, so it’s needed in three different contexts. With Vault, one document is used across all of these areas, upholding a clear chain of custody. Teams reuse materials with confidence, knowing that they’re always working with the right version.
In another scenario, regional brand teams leverage assets from corporate in new product packaging, certain the information is up-to-date without wasting time tracking down or re-entering the same details. As the sole source of compliant content for Veeva’s multichannel offerings, Vault also extends document reuse for medical, marketing, and sales teams to web sites, self-directed digital details, email, mobile, and even face-to-face interactions between field sales reps and healthcare professionals (HCPs). Vault enables direct content sharing across teams while preserving the independence that is so vital to each group’s needs and regulatory requirements.
“Traditionally, life sciences companies have had to choose between an inflexible centralized repository that supports content sharing and corporate control, but adds enormous complexity – and decentralized solutions that meet local or departmental requirements but limit content reuse and tracking. Either the business process was compromised or efficiency was impacted since there was no ability to address process, efficiency, and compliance across the board,” added Goldsmith. “Not anymore; Vault delivers to the needs of lines-of-business and corporate compliance teams.”
Veeva previewed Vault’s ability to now deliver a single source of truth to customers at its recent R&D Summit in Philadelphia, where more than 300 industry leaders representing 80 life sciences companies converged to share best practices for moving content to the cloud. These new Vault capabilities will be generally available in early Dec. 2014.
Sources:
1. Webster, Melissa, “Bridging the Information Worker Productivity Gap: New Challenges and Opportunities for IT,” IDC Health Insights, September 2012. For more, visit http://adobe.ly/Ul7ZZp
Truqap Combination Shines in Phase III Trial for Prostate Cancer
November 26th 2024Data from the CAPItello-281 trial show Truqap alongside abiraterone and androgen deprivation therapy achieved a statistically significant and clinically meaningful improvement in radiographic progression-free survival.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.