More than 600 life sciences industry leaders attended the 2016 Veeva R&D Summit in Philadelphia last week to learn how Veeva Systems’ cloud-based applications can streamline various aspects of their business operations including clinical, regulatory, and quality control practices.
In opening remarks, Veeva CEO and co-founder Peter Gassman discussed how building the industry cloud for life sciences requires a focus on understanding specific applications, data requirements and partnerships in the industry. Instead of spending years in the pipeline, Veeva delivers specific applications and enhancements to the market every few months.
Supporting this claim, Gassman announced the addition of two new products to the Veeva Vault Clinical suite – Veeva Vault EDC and Veeva Vault eSource. Designed to more efficiently run clinical trials, Vault EDC will speed critical workflows with easier accessibility to content, real-time updates and feedback, and even alerts, ultimately serving as a single source of truth for clinical data. Vault EDC and eSource are interoperable with existing Vault Clinical applications including Vault eTMF, Vault Study Startup, and Vault CTMF – all built natively on the same proven cloud platform.
Top Life Scienes Companies Discuss Optimizing Operations with Veeva Vault Applications
After Gassner’s opening remarks, Veeva customers presented, focusing on how they leverage Veeva’s various R&D cloud applications to solve urgent challenges. One Top 20 pharmaceutical company talked about implementing Veeva Vault QualityDocs to establish a standardized method of efficiently managing and validating information with contractors. With many services outsourced, greater data management, collaboration, and transparency are required among stakeholders in the supply chain.
In the past, the company had used emails, spreadsheets, and file sharing to exchange and capture information that did not have an audit trail. Using Veeva Vault QualityDoc, the company provides manufacturing recipes and other detailed information electronically to suppliers to support quality operations. The application also serves as its system of record by maintaining a permanent repository of quality information.
Biotech, The Medicines Company, also discussed how Veeva Vault RIM delivered the right suite of applications to fully integrate global regulatory information management capabilities on a single cloud-based platform. With no single repository for data, information was maintained on a desktop, hard drives, and file shares. As a result, staff spent time visiting multiple sources to retrieve information. And, since the data was not validated or archived, information was not audit-ready.
In 2015, The Medicines Company implemented Vault Submissions for authoring and managing regulatory submissions content. Using this application, the company validated data for the first time. Early the next year, the company added Vault Submissions Archive and Vault Registrations for improved visibility and data quality to streamline registration management. With a crosslink between Vault applications, the research company also implemented Veeva Vault eTMF. In addition to gaining new automated process capabilities that ensured data validity, the company was able to leverage best practices and adopt new, more efficient clinical trial processes.
Veeva Customers Talk One-on-One
Individual interviews with Veeva customers throughout the Summit further demonstrated the importance of Veeva Vault applications in supporting different life science operations.
For example, MacroGenics, a clinical-stage biopharmaceutical company, replaced an on-premise electronic data management system with Veeva Vault RIM to support growing submission requirements associated with multiple clinical-stage programs. Eliminating manual tasks, the Veeva Vault cloud solution gave MacroGenics visibility into content and automated functionality to generate reports and maintain an audit trail for major submissions.
“In the past, we manually updated a table of contents on a spreadsheet that outlined the status of documents for an IND filing,” noted Ron Hernando, director of regulatory operations at MacroGenics. “With Veeva Vault Submission, updates are automatic, with status easily referenced through a dashboard. As external business partners and offices collaborate on editing, reviewing and approving documents, Vault Submission also provides transparency into a document life cycle.”
MacroGenics has also adopted Vault Registration and Vault Submissions Archive to streamline registration processes and securely store a history of regulatory submissions.
Karyopharm Ensures Transparencies Among stakeholders
Ensuring transparency among different stakeholders to maintain quality is also critical to Karyopharm Therapeutics Inc., an oncology research company that outsources the majority of its manufacturing. Understanding that the use of multiple communication channels by different stakeholders was inhibiting collaboration and quality control, the company implemented Veeva Vault QualityDocs to gain better control over document management as well as visibility into workflow processes.
In the past, Karyopharm struggled to validate the chain of custody to assure it had the right document for submission. Now, with vendors using Vault QualityDocs, edits to documents are quickly vetted back and forth, accelerating review and approval workflows. Detailed audit trails and optimized content organization and search queries reduce compliance risk.
“With visibility into workflows, our vendors and us know the status of activities and can verify accuracy and completeness of manufacturing documents,” explains Craig Gassman, associate director of regulatory operations at Karyopharm. “By establishing a new workflow of information, Vault QualityDocs also helps develop best practices from active ingredient to substance and compound to final product.”
Veeva has seen broad industry adoption of its Vault QualityDocs and Vault QMS as the life sciences industry focuses on unifying quality management. Prompted by the need to seamlessly bring together quality work processes and content management, Veeva has added nearly 80 quality customers, including four of the top 20 companies, in less than four years look at more info. Eight customers adopted Vault QMS since the product was released only four months ago.
“Collaboration and access across global stakeholders are not only critical for achieving compliance, but also to ensure data integrity,” added Gassman. “With Veeva Vault Quality, all of our partners have real-time visibility in the cloud and we gain end-to-end control of critical documents and processes.”
CRO Relies on Veeva Vault eTMF to Add Value to Clients
In optimizing the value of critical relationships, Advanced Clinical, an award-winning clinical development organization that provides CRO, FSP, Quality & Validation and strategic staffing to the pharmaceutical/biotech industry streamlined operations with Veeva Vault eTMF by accelerating document collection and approvals throughout the entire process. Serving as a single source to share documents, Vault eTMF supports collaboration among investigating sites, enabling recipients to acknowledge receipt of documents and sign off after review electronically. An audit trail also supports compliance.
“With all information captured in a dashboard, sponsors can get real-time updates on clinical trials,” stated Jess Vicari, director of regulatory start-up & document management at Advanced Clinical. “Based in the cloud, the application is accessible at anytime, anywhere to support different audience timelines and locations. At the same time, Veeva Vault eTMF gives us the ability to control what type of information is viewed at specific points during the trial.”
In addition to reducing costs and gaining efficiencies around document exchange, Advanced Clinical is using Vault eTMF to add value by helping clients augment or improve particular functions as the dashboard contributes to uncovering bottlenecks and process inefficiencies so companies can better strategize SOP components.
In other news announced at Veeva’s 2016 R&D Summit, ICON is streamlining its regulatory and quality operations with Veeva Vault applications and inVentiv is expanding its adoption of the Veeva Vault Clinical Suite to expedite site activation for clients.
- For more on the Veeva suite of quality products, visit: veeva.com/quality
- For more on Veeva Vault QualityDocs, visit: veeva.com/QualityDocs
- For more on Veeva Vault RIM, visit https://www.veeva.com/products/vault-rim/
- For more on Veeva Vault Submissions, visit https://www.veeva.com/products/vault-submissions/
- For more on Veeva Vault eTMF, visit: veeva.com/eTMF
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