In this webinar, Pinar Benet spoke with Pawel Rucki, senior manager of TMF operations at GW Pharmaceuticals, about GW Pharma’s transition to an in-house TMF model, the benefits of sponsor TMF management, and best practices for making the switch.
Veeva Systems leads the way in Cloud-based software for the global life sciences industry. We serve more than 900 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs.
Our solutions unlock the benefits of modern Cloud-based architectures and mobile applications for your most critical business functions, without compromising industry-specific functionality or regulatory compliance. Our data, software, services and extensive ecosystem of partners is designed to support your most critical functions.
Our Clinical Operations Suite offers clinical operations applications to speed up trials and provide real-time visibility. Key to this is Veeva Vault Platform’s unique ability to manage both content and data. Now companies can eliminate systems silos, streamline end-to-end clinical trial processes, and improve collaboration for sponsors, CROs and clinical research centres.
Streamlined site selection and feasibility
Veeva Vault Study Startup enables faster time to site activation, allows for effective collaboration and helps you make better, more informed decisions. The solution lets you streamline site selection and feasibility, ethics committee approvals and site contract management to execute trials faster. It can achieve greater alignment across study partners through the seamless exchange of trial information to drive better decisions.
Real-time document management
Veeva Vault eTMF manages documents in real time in order to increase visibility and oversight and improve collaboration. By managing all TMF documents and processes in the same eTMF system, the solution ensures your documents are always ready for inspection. You can give study teams a real-time view of TMF completeness to help sponsors, CROs and sites work together to accelerate trials, and speed up trials with our suite of clinical applications on a single cloud platform.
Faster, higher-quality trial execution
Vault CTMS improves operational efficiency, streamlines collaboration and enables faster, higher-quality trial execution, offering a real-time view across clinical trial processes. The solution lets you equip study teams with role-based dashboards and intuitive navigation to improve productivity and speed trial execution, and enables proactive closed-loop issue management and improvement of strategic trial planning by giving you a real-time view of trial status. The software provides one system of record for shared study start-up, TMF, CTMS and payments content, improving efficiency and unifying operations.
Faster payment processes
Veeva Vault Payments lets you speed up payment processes within existing trial management workflows and ensure sites get paid on time. You can automate payment tracking for a simpler, more efficient process and automatically match clinical activities with a site’s fee schedule for greater accuracy. Real-time reports and dashboards provide full visibility to upcoming and pending site payments to optimise execution and cash flow.
Automated trial information flow
Veeva Site Connect allows trial information to flow automatically between Veeva Clinical applications used by sponsors and CROs and Veeva SiteVault, a compliant eISF application for clinical research sites. With Veeva Site Connect, study partners streamline information sharing across end-to-end trial processes, allowing for better collaboration and faster trials. You can seamlessly automate the flow of information across study partners, processes and systems so that more time is spent on treating patients instead of administrative activities, improving collaboration and efficiency.
Better management of Vault applications
Veeva Vault Platform lets you customise, integrate and extend Vault applications or create your own applications. The platform is designed to meet the most rigorous usability, scalability, performance, validation and security requirements. IT teams and power users can modify existing applications or configure new ones with the simple point-and-click interface. Veeva Vault can manage both content and data in a single platform, allowing you to quickly deploy powerful applications that manage end-to-end processes with related content, data and workflows.
About Veeva Systems
Veeva Services offers clinical, regulatory, quality, safety, medical and commercial solutions for companies in the life science industry. We are headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia and Latin America.
To facilitate virtual TMF inspections and improve efficiency, the European Medicines Agency (EMA) encourages sponsors to provide inspectors direct system access to the eTMF on an ongoing basis.