With technical capabilities advancing and new solutions entering the market, clinical trial data management has been steadily evolving for years. But the COVID-19 pandemic has dramatically accelerated the shift towards automated data collection technologies. In this blog, we review this technological progression—and where the industry still needs to go.
Artificial intelligence, machine learning, natural language processing and blockchain are just some of the technologies in use that have advanced the way we capture and analyze clinical data. The applications these advancements have spawned are truly transformative.
While technical advances are shaping the way clinical trials are being conducted, it still was not so long ago that paper was the primary method for clinical trial data management. In fact, some clinical trials still use paper today—and many sponsors, CROs, sites, investigators and patients rely on manual processes using outdated technologies to collaborate.
COVID-19’s Impact on Clinical Trial Data Management & Collaboration
Collaboration and connectivity are crucial in clinical trial data management. So, the implications of the pandemic have, by necessity, led to significant advancements in critical data capture and management capabilities.
When situations like this arise, the need for these advancements become more pertinent. Of course, no one is suggesting that COVID-19 has been good for any company or technology, but it did require changing procedures for sponsors to better interact with their trial partners. For example, monitoring visits used to be conducted in-person, but in the era of the pandemic, remote monitoring has become the de-facto standard almost overnight. And it is here to stay.
Here’s how technology has advanced so far and where it still needs to go for better collaboration and success.
Legacy Internal Platforms
While integrated platform technologies have helped sponsors reduce the duplicative efforts of managing trial operations and trial master file (TMF) documents, the process still seems to break down when it comes to sharing information with partners. In fact, collaboration between sponsors, CROs and sites falls back on manual processes reminiscent of paper documentation.
Sponsors typically download and email documents when they need to be shared with a partner. And when the partner provides required files to sponsors, they do the same thing. The sponsor often collects the needed documents from an email and then uploads to their internal system. Even though internal systems have helped a lot by managing the plethora of trial documentation electronically instead of on paper, it is clear that there is room for growth when it comes to external collaboration.
Custom Sponsor Portals: Good or Bad?
To solve the beforementioned problems, some sponsor organizations have developed custom portals to varying degrees of success.
The good thing is that they provide substantial benefits to sponsors because they integrate with their internal systems. This mitigates the need to manually upload to the appropriate solution, and it also provides a collaboration pathway for trial partners.
The primary shortcoming is that these portals are unique to each sponsor organization. This requires sites, for example, to manage trial documents and communication through multiple systems depending on the sponsors they contract with.
So, what else is available?
The Promise of Investigator Platforms
That leads us to industry-wide investigator platforms, or shared investigator platforms (SIPs).
SIPs are designed to be a single point of access, linking investigators to multiple clinical trial sponsors. The concept is that there can be a standards-based portal solution to enable two-way collaboration between sponsors and CROs with the clinical sites conducting a trial.
The promises of SIPs are apparent, but, somehow, they never seemed to have materialized.
Enter Veeva Systems
The latest contender to tackle this long-standing problem is none other than Veeva Systems.
Everyone knows Veeva for their industry benchmark solutions, and their Vault platform has transformed clinical and regulatory operations for the customers they serve. Could they be the ones who finally solve this issue that has hampered clinical trial data management and collaboration for so long?
Perhaps it is too soon for Veeva to declare victory, but the early signs certainly look good. Let’s examine their offerings for each clinical stakeholder:
For Sites: SiteVault
Prior to the pandemic, Veeva’s engineers developed SiteVault. SiteVault is a platform that sites can use for managing trials—regardless of sponsor. It is licensed to the site and web-based, and Veeva provides all of the training needed to get going very quickly. Plus, they have a free version.
For Sponsors: SiteConnect
For sponsors, they offer SiteConnect, a solution that promises ease of integration with their partner’s SiteVault. It enables sponsors and sites to share documents and data much more efficiently because it connects a sponsor’s Vault directly with the site. It is new and, like many new solutions, functionality will continue to be developed to make the solution more and more robust over time.
With that said, the combination of SiteVault and SiteConnect does solve many of the collaboration issues experienced by everyone involved in the clinical trial data management.
For Patients: MyVeeva
Most recently, Veeva launched MyVeeva for Patients, a multichannel patient portal to enable patients, doctors and clinical research coordinators to collaborate remotely—for free.
Essentially, Veeva is building an entire ecosystem to benefit clinical trial data management, connecting sponsors, CROs, sites and even patients!
All of this technological change is a good thing—as long as the solutions are adopted. Time will tell, but Veeva’s solutions are off to a great start. Early adopters will help shape the solutions for everyone’s benefit. Either way, it’s clear the industry is ready to mature clinical trial data management technology and collaboration.
Daelight Solutions is a preferred Veeva Vault Services Partner. As you look to make the best decisions regarding this exciting next generation of enhanced trial collaboration solutions, our team of technologists and business domain SME’s can help you assess your current technical and business landscape and develop the optimal roadmap for success. Learn more about how we work with clinical trials, and contact our team to talk about your needs.