Q&A: How Technology Reduces Study Start-up Delays

Study start-up is one of the hottest topics in clinical today. According to a recent industry-wide survey, 83% of companies have an initiative underway, or will within the next year, to improve their study start-up processes.

Given this focus, my SCOPE conference presentation on ‘Transforming Study Start-up’ generated a lot of interest and questions on training, change management, and compliance using Veeva solutions.

This post answers the questions discussed during my presentation.

Streamlining Clinical Operations

Q: We are using Vault eTMF, but our CTMS and study start-up systems are disconnected from eTMF and each other. Because of that, we struggle with many issues including duplicate data entry and getting study start-up documents into Vault eTMF on time. Are your other customers facing this same challenge?

A: Yes, the challenge of disparate systems is pervasive. Nearly all (99%) in the Veeva Unified Clinical Operations survey reported the need to unify their clinical trial systems and processes to improve efficiency and collaboration.

Unifying CTMS, eTMF, and study start-up processes eliminates duplicative efforts such as creation of the same study in multiple applications.

It also makes trial processes more efficient by reducing the number of steps. For example, moving from disconnected environment to a unified approach may cut up to 17 out of 35 steps in a site selection process.

Finally, a unified approach streamlines all processes in a clinical trial. For example, the documents uploaded into Vault Study Startup are auto-filed in Vault eTMF.

Training and Change Management

Q: Implementing new systems or applications is challenging and requires investment in training and change management processes. How can Veeva help?

A: Veeva uses a three-pronged approach to help facilitate smooth transition:

• Partnership — Veeva forms a close partnership with customers through all phases of adoption. During implementation and after go-live, our services, strategy, and product teams help customers develop training and change management and deployment plans.
• Ease of use — Veeva’s intuitive and easy-to-use applications reduce training time and facilitate faster adoption. For example, Vault Study Startup Homepage provides at-a-glance visibility into tasks and priorities, greatly simplifying a study start-up specialist’s day-to-day job.
• Unified platform — Veeva’s clinical applications such as eTMF, CTMS, and study start-up are built on a single, unified platform, providing a consistent user experience and eliminating the need for custom integrations.

Global Regulatory Environments: Technologies for New Regulations

Q: How does Veeva and Vault Study Startup support new regulations, such as GDPR?

A: Veeva continuously monitors the regulatory environment for new and evolving requirements. Any changes are delivered to our customers through regular software updates three times per year.

An example is the new EU directive that is soon to be adopted by EU member states for streamlining submission process across multiple countries. As this new centralized submission will take effect, Vault Study Startup will support the new process for our customers.

Site Operational Needs and Systems

Q: As a research site, we are willing to use sponsor systems, but often it is obvious to us that those systems are more focused on the operational needs of the sponsor, not us. Do you have any thoughts or approach for how we can address our own operational needs?

A: Site-specific clinical applications, such as Veeva SiteVault, are now available for improving efficiency, quality, and speed of execution. SiteVault help sites effectively manage regulatory documentation and trial information to speed clinical research.

Watch this webinar featuring Penn Medicine for tips on how sites can evaluate, plan, and adopt technologies to reduce the administrative burden in clinical research.

Learn more

Here’s some additional information on the topic you may find of interest:

• Unified Clinical Environment — Looks at how a unified clinical environment drives speed and efficiency.
• Streamlining Study Start-up — Industry research on start-up from the 2018 Veeva Unified Clinical Operations Survey.
• Veeva and GDPR Compliance — Information and resources for GDPR compliance.