In August of this year, we released Medable Studio, a sponsor-facing interface within our software-as-a-service (SaaS) clinical trial platform that enables customers to see previews of their clinical instruments, assessments, translations, and more as they create or edit them.
The rise of SaaS has transformed industries, including life sciences, by enabling new possibilities. For instance, Salesforce revolutionized how organizations managed their customers and future clients with its cloud-based software, enhancing accessibility and collaboration. Similarly, Canva made graphic design tools accessible to all, empowering professionals and casual users alike.
Our industry can learn from these success stories by adopting SaaS platforms to boost efficiency, collaboration, and innovation and by identifying longstanding research challenges that can be made more efficient.
As organizations like Medable and others continue to offer self-service capabilities, the nature of how sponsors conduct clinical research will continue to evolve. In fact, Research and Markets previously reported that the “global healthcare SaaS market grew from $18.33 billion in 2022 to $21.56 billion in 2023 and is expected to reach $42.13 billion by 2027, with a CAGR of 18.2%.”
This capability for self-service takes place alongside an ever-digitizing clinical trial industry that sees double-digit compound annual growth rates (CAGRs) across DHTs, digital measures, eCOA, eConsent, telehealth, and more.
The result is that clinical research may officially be in its next major SaaS era.
What does that mean for clinical trials, sponsors, and CROs? Read ahead to find out.
What SaaS has enabled for pharma historically
From an organizational standpoint, SaaS enables organizations to “own” the technology process behind key trial tasks, whether they do it themselves or work with a vendor to use the system.
In clinical research, the first SaaS systems rose to prominence in the mid-2000s as clinical trial management systems (CTMS) helped streamline and centralize clinical trial management.
SaaS platforms in clinical research management offer several key advantages.
- They provide centralized real-time data access from multiple locations, enabling stakeholders to make swift, informed decisions.
- They can significantly enhance collaboration among research teams, sponsors, and regulatory bodies by facilitating better communication.
- Another significant benefit is cost efficiency, as SaaS platforms reduce the need for extensive IT infrastructure, thus lowering the overall expenses associated with clinical trials.
- Lastly, these platforms offer excellent scalability, quickly adapting to the size and requirements of different trials. This flexibility allows for efficient resource management, whether scaling up for more extensive studies or scaling down for smaller ones.
What sponsors can expect from this new era of SaaS
Instant creation of COAs, instruments, assessments, etc., with fewer rounds of reviews
SaaS systems like Medable Studio enable sponsors to instantly create clinical outcome assessments (COAs), instruments, assessments, and more. Unlike traditional COA creation, SaaS vendors eliminate the need for programmers by reducing the back-and-forth typically required to create these resources. These systems enable anyone to create COAs while instantly previewing them on-screen, something impossible before SaaS technology.
Here, SaaS helps reduce time and cost by breaking the standard linear flow development that typically bogs down COA creation, taking eCOA off of the critical path.
Simplified translations
Maintaining and deploying accurate translations of clinical trial instruments and assessments poses significant challenges for sponsors and CROs due to the need for linguistic precision, cultural adaptation, and consistent updates across multiple languages and regulatory environments.
With SaaS applications, organizations are able to manage all of the translations from a centralized location, making it easier to deploy globally while enabling easier re-use and standardization of previously translated forms.
Much like the instant COA creation and preview features, organizations using SaaS solutions can instantly preview files from vendors, doing validation in real-time and editing only what they need to send back for translation. Much like it does for SaaS COAs, instruments, and assessments, this reduction in back and forth saves countless hours in time.
Document standardization and repeatability through libraries
Many customers find value in taking components of studies they've run before or have ongoing and replicating those in future studies, whether the entire study design or specific components.
SaaS platforms offer libraries that enable sponsors and CROs to easily store, find, and edit vast amounts of assessments, instruments, translations, and more. This enables easier standardization, version control, and more, as centralized document management combined with live editing and previews enhances the ability to repeat and standardize what’s worked well in the past.
Better data Integration, standardization, and harmonization
Today’s SaaS platforms are beginning to expand their data integration and harmonization capabilities, serving as centralized hubs for integrating diverse data sources. These platforms can seamlessly incorporate data from electronic health records (EHRs), wearable devices, genomic databases, and real-world evidence sources, creating a holistic view of patient health and trial outcomes.
For example, think of Amazon’s current real-world data warehouse, which collects terabytes of daily data. In this era of SaaS, a continuous, multi-modal data stream can, and in some cases, already does, provide unprecedented insights into patient health and treatment efficacy.
In this era, data can be paired with artificial intelligence to standardize better, format, and display data. This harmonization will go beyond simple standardization, intelligently interpreting and aligning data to ensure consistency and comparability across different studies and data types. Additionally, SaaS platforms can support advanced AI algorithms to continuously analyze incoming data streams, identifying potential safety concerns, protocol deviations, or emerging real-time efficacy signals. These systems will generate intelligent alerts, prioritizing issues that require human intervention and potentially automating certain responses.
SaaS' benefits mean it's here to stay
As we embrace this new era of SaaS in clinical research, it's clear that the landscape of clinical trials is undergoing a significant transformation. SaaS platforms are revolutionizing how sponsors and CROs conduct clinical trials, from the instant creation of clinical instruments to simplified translations, standardization through libraries, and enhanced data integration.
As the industry progresses, sponsors, CROs, and other stakeholders must stay informed about these technological advancements and consider how they can integrate SaaS solutions into their clinical trial strategies. By doing so, they can improve their operational efficiency and contribute to faster, more effective drug development processes that ultimately benefit patients worldwide.
