There’s no doubt that study launches come with extremely high stakes for sponsors.
This period requires precise coordination over numerous critical activities across multiple stakeholders, including regulatory bodies, ethics committees, investigator sites, and internal teams.
Any lapses here can significantly impact the entire study timeline, budget, and, in some cases, the study’s integrity.
Lack of control and transparency during study launch
For years, sponsors and CROs have lamented the lack of control and transparency, particularly with technology, during study launches.
Many sponsors and CROs work with vendors to help with crucial launch components, such as creating, deploying, and translating clinical outcome assessments. This reliance on external partners can make managing trial launches challenging.
For example, organizations commonly identify problems like text getting cut off by digital displays or branching logic not working correctly during user acceptance testing (UAT). Often, this is close to the trial launch date.
Traditionally, sponsors would need to request that change from the vendor, who then must talk to a coder to make the change. Next, the vendor returns a screenshot of the coded change to the sponsor.
Ultimately, the inability to see and manage the full scope of a study launch can undermine a sponsor's confidence in the process. Thus, addressing transparency is crucial for sponsors looking to streamline their launch workflows and reduce risk.
Downsides with linear development and flow
Traditionally, clinical trial development has followed a linear, sequential workflow.
This involves:
- Initiating the project with a kickoff meeting,
- Discussing needs,
- Drafting spec documents,
- Going back and forth with vendors and their coders for changers,
- Obtaining final approval, and finally,
- Commencing the build phase.
While comprehensive, this approach is often time-consuming and requires more resources and agility to adapt to evolving requirements, regulations, and most importantly - changes.
For example, imagine that the text displayed on an eCOA is getting cut off by a digital display. As we outlined previously, sponsors would need to request that change from the vendor, who then must talk to a coder to make the change. Next, the vendor returns a screenshot of the coded change to the sponsor.
Not only does this take time, it’s harder to manage.
Changes from protocol revisions
Protocol revisions are a common issue during trial launches. Tufts CSDD research shows that the average phase 3 clinical trial experiences 2.3 revisions, with many occuring before the FPI (first patient in) date. Our data at Medable supports Tufts CSDD’s findings, showing an average of two change orders per trial per customer. One reason this occurs is due to the complexity of modern trials. Sponsors and CROs start trial builds earlier, using draft protocols to ensure they don’t miss key dates.
However, protocols can change as they’re finalized, creating a ripple effect across multiple organizations and causing development delays. Again, this is due to the linear development flow we mentioned above.
Additionally, Tufts CSDD wrote that a “relatively high percentage of substantial amendments—approximately one in four— were implemented before the first patient had presented for their first visit (FPFV).” Here, a change at this period is much more likely to be under significant time constraints, and any changes can take technology builds back to square one.
In December 2023, a Ken Getz-authored Applied Clinical Trials article highlighted the impact of protocol changes on trial launches. In it, Mr. Getz wrote, “Sponsors have resigned to the fact that complex protocol designs are commonplace...Sponsors also acknowledge that rising levels of complexity are inevitable—as are the associated number of protocol amendments.
As Mr Getz later noted, “The delays and disruptions caused by protocol amendments are garnering notable attention at this time… Sponsors and others are hoping to optimize protocol amendment experience through reducing the need to amend and managing and minimizing process inefficiencies…automation and artificial intelligence (AI)-enabled approaches are also aspirational solutions to streamline global changes.”
Lack of library organization and readiness
Lastly, sponsors and CROs are often slowed down during trial launches by issues with instruments and assessments, such as regulatory non-compliance, digital errors, formatting errors, inconsistencies, and version differences.
For instance, regulatory guidelines for instruments and assessments are constantly evolving.
Additionally, this landscape varies across countries and regions. Sponsors and CROs must be familiar with the specific requirements of the countries where their studies are conducted, which can be particularly challenging for multinational studies.
Solving these challenges with SaaS technology
To solve these issues, the clinical trials industry can take notes from other transformative SaaS technologies. For instance, think of Salesforce and the way it transformed customer relationship management tools. Previously, sales teams had either paper notes or, later, non-cloud digital notes/records to manage their sales cycle. As of today, Salesforce is a multi-faceted cloud SaaS platform that integrates cross-functional collaboration, always up-to-date information, and continuous evolution and improvements. Let’s analyze some of the beneficial features of SaaS platforms in clinical trials.
SaaS platforms can provide a centralized hub where sponsors and CROs can track real-time updates on key deliverables. This visibility allows for quicker identification and resolution of issues, such as text display problems or logic errors, often caught late during user acceptance testing (UAT).
As mentioned, traditional linear development workflows are time-consuming and inflexible. The best SaaS tools, like Medable Studio, enable a more agile approach, allowing simultaneous work on different aspects of the tria (much like a Google document)l. They also remove coding from the process with intuitive point-and-click interfaces. This can significantly reduce the time from kickoff to launch, as teams can collaborate in real time, making adjustments as needed without restarting the entire process.
With an average of 2.3 revisions per Phase 3 trial, managing protocol changes is a significant challenge. SaaS platforms can facilitate rapid adjustments across all relevant documents and systems through libraries, minimizing the ripple effect of changes. These libraries contain all an organization's instruments and assessments and help better ensure version control, regulatory compliance, and consistency across studies. These tools can automatically update to reflect the latest regulatory guidelines, reducing the risk of non-compliance and formatting errors that often slow down trial launches.
Medable Studio: the most intuitive user interface for transparency and control
Medable Studio is part of our enterprise-wide platform and gives sponsors and study teams full access to the study launch process, whether self-service or full-service.
Studio enables a collaborative, iterative development model where design and build can happen concurrently, which is made possible through its built-in preview and testing capabilities.
Put simply; sponsors can see exactly what’s happening live across assessments, instruments, translations, and more. This is true whether their internal teams handle launch activities or whether vendors handle them, a stark contrast to the traditional technology development process.
Additionally, because Studio’s interface was designed to be simple, it empowers users of all technical levels, eliminating the need for specialized builder expertise to access, build, deploy, or manage studies, assessments, and libraries. This level of transparency and accessibility marks a significant leap forward in clinical trial management, allowing sponsors to stay informed and engaged throughout the process.
Studio also helps minimize the impact of changes, enabling sponsors to update their assessments and instruments in real time. The result is transparency and fewer rounds of review, regardless of whether the process is handled internally or by vendors.
As we move forward in an era of increasingly complex clinical trials, tools like Medable Studio are not just beneficial – they're essential.
Learn more at medable.com/studio.
