Choice and Control: Data Sharing with Connected Clinical Trials

Long before the COVID-19 pandemic, legacy processes for data sharing and collaboration were called out as key barriers to modernizing clinical trials. More recently, the global pandemic accelerated the adoption of new technologies to run clinical trial processes, pushing the industry to address the fundamental challenges surrounding how information is shared across sponsors, CROs, and clinical research sites.

While progress has been made to advance the industry towards more digital ways of working, concerns around data privacy and security are top of mind, particularly in the context of systems that are used to share study documents and site staff information that may contain personal data with sponsors and CROs. The need to safeguard what information is shared – and with whom – is more important today than ever before, especially as the industry moves toward a digitally connected clinical trial environment.

As a cloud solution provider to the life sciences industry, the importance of data privacy and security is part of our DNA. We have built a strong quality, compliance, and privacy team that works in close collaboration with our product and strategy teams and our customers. We ensure the same privacy and security controls for all our customers (sites, sponsors, and CROs).

Our solutions, like Veeva SiteVault (for clinical research sites) and Veeva Site Connect (for sponsors and CROs to streamline site collaboration), provide a base framework for customers to populate with data and documents (information) while at the same time improving how clinical trial information is shared. Our goal is to allow for controlled sharing of trial information, including personal data, while enabling frictionless collaboration between sites and sponsors/CROs. But what does this mean in practice?

We think the right model for site/sponsor collaboration in the life sciences industry is centered around choice, control, and transparency:

A site-centric approach to technology

We believe it is critical to empower clinical research sites with high-quality digital technologies that meet their specific and unique needs. Sites regularly use a mix of manual, paper-based processes, their own systems, and systems that sponsors and CROs require them to use that are all too often not designed to support the site’s operations. To reduce administrative burden, sites are shifting towards more digital, connected ways of working by adopting site-centric technology. These advanced, fit-for-purpose site solutions enable sites to streamline their operations, collaborate more easily with sponsors, and focus more on the work of treating patients. With proper design, these site-centric systems also ensure that sites own and control their systems and the data and documentation stored within them.

Customer ownership and control of clinical data and documents

We believe sites deserve a choice around who their data is shared with and how that information is used. Veeva does not stipulate how documents and data are shared. We put the control in the hands of the customers (sites and sponsors/CROs). For example, in a connected study, profile and study information are automatically shared between sites on SiteVault and sponsor or CROs on Vault Clinical. Before this can happen, an invitation to participate in a study is generated by the sponsor or CRO and sent digitally to sites. Sites can accept the invitation before sharing information with the inviting sponsor or CRO. Personal data for clinical trial investigators, other staff, and study documents are only shared between parties in a 1:1 manner after agreeing to collaborate on a specific study.

Choice and control should not come at the expense of efficiency gains

Creating frictionless collaboration and a better experience for sites can be achieved without compromising data privacy, security, and control. Data can and should be shared in an automated fashion, reducing rework at the site level while still maintaining control. For example, site personal data and profile information such as CVs are uploaded once and shared with each sponsor and CROs the site works with. Sites can re-use information across sponsors and CROs, reducing redundancy while retaining full control of their data.

Veeva has been working closely with sponsors, CROs, and sites to understand how we can provide solutions that streamline collaboration and controlled data-sharing. In our next blog, we’ll detail the specific features of Veeva Site Connect and Veeva SiteVault and how they create a controlled environment for information sharing that delivers transparency and privacy.