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 applications unlock the benefits of modern Cloud-based software solutions 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 are designed to support your most critical functions.
Our Clinical Operations Suite offers clinical Cloud-based software solutions 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 Cloud-based document management
Veeva Vault eTMF is a Cloud-based software solution that 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 software solutions
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 Cloud-based payment solutions
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 Cloud-based 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 software solutions
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.
Vault Clinical product strategy director Sarah O’Hora shares findings from Veeva’s 2019 Unified Clinical Operations survey concerning the adoption of purpose-built eTMF platforms.
The Veeva 2020 Unified Clinical Operations Survey Report examines the life sciences industry’s progress toward modernizing clinical operations by gathering the experiences and opinions of more than 500 clinical operations professionals from around the globe.
While maintaining an active TMF process within your organization can help establish a culture of inspection-readiness, inspection preparation is a distinct process that readies your entire organization for a successful inspection.
The best preparation for a regulatory inspection starts with a strong culture of inspection readiness and a well-documented SOP. With these in place, the tips given in this white paper will help your organization successfully navigate the day of inspection.
Preparing for a regulatory inspection can be daunting – but it doesn’t have to be. The best approach to reduce the stress of an inspection is to create a culture of compliance by building inspection readiness practices into daily operations.
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.
100% of clinical leaders see need for change as manual processes delay study activation
Sponsors and CROs accelerate move to unify systems and processes
New application will connect sponsors and sites for better collaboration and faster study execution
New Veeva Clinical Network Applications Connect Sponsors, Sites, and Patients to Accelerate Clinical Trials
Veeva Site Connect and Veeva eConsent advance industry’s move to paperless and patient-centric clinical trials