Launch & Eligibility
What happened on January 6th?
Veeva officially launched SiteVault CTMS for general availability. This means the CTMS application, which was previously in limited release, is accessible to all clinical research sites.
Who is eligible for the free version of SiteVault CTMS?
The “SiteVault Free” edition (which now includes CTMS, eISF, and eConsent) is available to any site managing 20 or fewer concurrent active studies. This is over 90% of research sites, globally.
What happens if my site has more than 20 active studies?
Sites managing more than 20 active trials are eligible for SiteVault Enterprise. The Enterprise tier provides the same core CTMS capabilities but includes additional features like Single Sign-On (SSO), API access for custom integrations, and dedicated account management to support larger-scale operations.
Features & Capabilities
What specific tasks can I perform in SiteVault CTMS?
SiteVault CTMS is designed to centralize your trial operations. Key features include:
- Study Calendars: Building and customizing study-specific visit schedules.
- Participant Tracking: Logging patient visits and procedures in real-time.
- Financial Management: Tracking study budgets, automating invoice generation, and reconciling payments.
- Customizable Reporting & Dashboards: Eliminate manual spreadsheets with access to real-time dashboards and exportable reports. You can track site-wide metrics such as staff workload, enrollment curves, earned vs. forecasted revenue, and upcoming milestone dates at a glance.
How does CTMS work with my existing SiteVault eISF?
The system is unified. This means your study and investigator data are shared across the platform. For example, when you complete a participant visit in CTMS, the related documentation can be seamlessly managed in your eISF, reducing duplicate data entry and manual errors.
Does SiteVault CTMS connect with my sponsors?
Yes. For sponsors and CROs using Veeva’s Clinical Platform, SiteVault CTMS allows for bidirectional data flow. This streamlines the exchange of information, such as recruitment status and milestone completions, directly between the site and the sponsor.
Pricing & Support
Is there really no cost for sites with less than 20 studies?
As part of Veeva’s commitment as a Public Benefit Corporation, the SiteVault suite (including the new CTMS) is free for these sites. There are no hidden per-user or per-study fees for the standard version.
Is training provided for the new CTMS features?
Yes. To support the January 6th launch, Veeva has released the SiteVault CTMS Jumpstart Webinar Series. This is a four-part series covering:
- Study Schedules & Intro
- Study Budgets
- Participant Visits
- Invoices & Payments
How do I get access if I am already a SiteVault eISF user?
- Free Version Users: CTMS will be automatically enabled in your account on January 6th. No action is required.
- Enterprise Users: Reach out to your Site Success Consultant to coordinate the enablement and any necessary configuration.
Data & Compliance
Who owns the data entered into SiteVault CTMS?
The site owns and controls all data and documents entered into SiteVault. Veeva provides the technology, but the site maintains full ownership and determines who has access to the information.
Is the system compliant with global regulations?
Yes. SiteVault CTMS is built to comply with 21 CFR Part 11 and HIPAA requirements, as well as international standards like GDPR. It includes full audit trails, electronic signatures, and secure access controls.
