What do we want? To focus on the science! When do we want it? Now!
A senior executive at a biotech firm recently asked me if his staff needed to be logged into Vault all day long while working. The question immediately brought me back to my days in clinical development and the teeth-grinding frustration of logging in and out of a seemingly endless number of systems. “I’d rather see them spend their time doing what they really love. And when they need to document, collect, or search for content and data, they can do it easily and quickly,” I reassured him.
When I was in clinical development, my team and I loved working on the science. We all shared a passion to bring new medicines to patients faster and cheaper, but without compromising safety and quality. Unfortunately, the momentum of our work was often stalled by administrative tasks. Tracking, searching, and logging in and out of systems was an ongoing disruption and not core to our “real work.”
Similar to our biotech customer, our clinical development team back in the day wanted to work in the most efficient way possible and not be burdened by mundane tasks such as manually tracking our work or site content. We wanted to enter information into a system once, use it in a variety of ways, and make it available to others, when and how they needed it. We didn’t want to wait for data and content, but instead have it available when it was created or entered. Ultimately, we wanted to spend as little time, energy, and money as possible pulling information together. We were a group with a lot of demands!
Now imagine how this way of working could impact the study start-up process. Create and finalize an essential document package materials within a single content management platform. Push country-specific tasks and documentation to sites for completion. Manage the workflow through the never-ending maze of country-level intelligence. Push regulatory submissions documents to the right individuals. And finally, document the site interactions in a trip report or site contact log – all through a unified clinical suite without ever logging out of the system. Not only can study teams do their work more efficiently, but senior leaders can also monitor progress in real-time, take actions, and make decisions faster.
Unfortunately, the reality for many life sciences companies is they have a hodge-podge of legacy, disparate technology either acquired or built originally for a different purpose and then loosely integrated, but fundamentally not developed to complement one another. For them, the concept of a unified clinical suite seems like fantasy – a platform that can provide portfolio level metrics, allow organizations to provide adequate sponsor oversight, and enable collaboration with both internal and external stakeholders in a secure and compliant way?
Creating this unified suite is the main objective of the Veeva Vault team – we made tremendous strides over the past year making it a reality. We added Vault CTMS and Vault Study Startup, to complement the industry-leading Vault eTMF as the core of our clinical operations suite. These three applications work seamlessly together, allowing processes to be managed in their entirety and data to be leveraged in multiple places simultaneously.
Life sciences organizations are making the move. Read how inVentiv Health is managing their study start-up processes across Vault Study Startup and Vault eTMF. Watch this short video on how Vault Clinical unifies clinical operations on one platform.