SaaS solutions, or software as a service, refer to platforms accessible via the Internet that enable businesses to benefit from IT tools without having to install or maintain software locally. These solutions are hosted in the cloud, accessible from any connected device, and offer continuously updated functionality. In the context of clinical trials, SaaS solutions centralize data, automate administrative processes, and ensure better collaboration between research teams, investigators and partners.

Clinical trials involve a massive amount of data to manage, including patient information, bioassay results, adverse event tracking and regulatory reporting. SaaS solutions such as Medidata and Veeva Clinical Suite offer centralized platforms for managing the entire clinical trial lifecycle. These tools enable data to be collected, stored and analyzed in real time, reducing reliance on manual processes. They enable :

– Data centralization: All information is stored in a single, secure space, avoiding data silos between different sites or teams.
– Process automation: Manual tasks, such as report creation or data verification, are automated to reduce errors and accelerate turnaround times.
– Better traceability: The platforms record every data modification, guaranteeing total transparency to meet the requirements of regulatory authorities.
– Real-time access: Test data is immediately available to all authorized parties, facilitating rapid, informed decision-making.

These platforms operate through user-friendly, subscription-based interfaces that integrate protocol design, data tracking and reporting tools. They enable research teams to work in sync, monitoring trial progress and instantly sharing critical data. Their cloud-based architecture guarantees constant availability of information, even in the event of local technical failures – an essential advantage in contexts where every day counts, as with vaccines. Here’s how they fit into clinical trials:

Protocol design: SaaS platforms help create protocols by integrating predefined templates and automatically validating regulatory compliance.
Patient recruitment: They facilitate recruitment by analyzing inclusion criteria and rapidly identifying potential patients.
Trial monitoring: Clinical data are collected and analyzed in real time, enabling investigators to monitor trial progress.
Reporting and auditing: Platforms generate detailed, compliant reports, reducing documentation time and improving transparency.

Inhibrx, a biopharmaceutical company specializing in the development of targeted therapies, has integrated Veeva’s Clinical Trial Management System (CTMS) to centralize its study data and documents. This connected platform enables Inhibrx to streamline its processes and improve collaboration with its contract research partners. By adopting this solution, Inhibrx has been able to automate the flow of information, reduce manual tasks and accelerate critical decision-making, resulting in faster, more efficient testing.

In January 2025, Veeva Systems announced that over 200 companies, including 17 of the world’s top 20 biopharmaceutical companies, are now using its clinical trial management system to improve trial efficiency and strengthen collaboration between stakeholders. This massive adoption testifies to the confidence placed in this SaaS solution to manage the growing complexity of clinical studies and the associated volumes of data. Companies can centralize data in real time, quickly identify potential problems and ensure ongoing compliance with international regulations, accelerating the development of new treatments.

“Veeva’s clinical trial management system is the hub of our trials, allowing study metrics and documents to flow seamlessly through our ecosystem,” said Bonne Adams, Vice President of Operations at Inhibrx. “Using clinical applications on a connected platform saves our small team time and effort, while improving the way we work with our partner contract research organizations.”

Medidata, a company owned by Dassault Systèmes since 2019, offers a SaaS platform specialized in clinical trial management. This cloud solution enables real-time collection and analysis of patient data, improving trial quality and participant safety. In 2024, Medidata launched Clinical Data Studio, a technology integrating artificial intelligence and machine learning to accelerate data review and reconciliation by up to 80%. This innovation aims to modernize clinical trial management, optimize patient selection and ensure better regulatory compliance. Thanks to its data-driven approach, Medidata helps pharmaceutical and biotech companies optimize their processes and reduce the costs associated with developing new treatments.

During the development of its COVID-19 vaccine (mRNA-1273), Moderna collaborated with Medidata to optimize and accelerate its clinical trials. The Phase III trial, which involved 30,000 participants in the United States, was completed in just 12 weeks thanks to the use of the Rave Clinical Cloud platform. Moderna utilized several of Medidata’s SaaS solutions, including Rave EDC for electronic data capture of patient information and Rave eCOA for the digital evaluation of clinical outcomes. These tools enabled real-time data collection and analysis, reducing errors and speeding up the regulatory validation process. Additionally, the integration of decentralized solutions facilitated volunteer participation by allowing them to use their own devices to report side effects, thereby minimizing clinic visits and shortening timelines. This collaboration played a key role in the rapid acquisition of emergency authorization, demonstrating the crucial impact of SaaS solutions in modernizing clinical trials and accelerating vaccine time-to-market.

The integration of SaaS solutions in clinical trials goes beyond process optimization and timeline acceleration—it also plays a crucial role in cost reduction. Traditionally, clinical trials are among the most expensive components of vaccine development, accounting for up to 50% of the total budget. With advanced digital tools, pharmaceutical companies can now lower these costs while ensuring scientific integrity and regulatory compliance.

SaaS platforms automate numerous administrative and logistical tasks, thereby reducing reliance on costly manual processes. They enable:

• Elimination of manual errors, which would otherwise require expensive corrections.
• Simplified document management, avoiding paperwork overload and reducing storage costs.
• More efficient trial monitoring, optimizing the use of both human and material resources.

Patient recruitment is a major challenge in terms of both cost and time. By leveraging artificial intelligence integrated into SaaS solutions, pharmaceutical companies can:

• Identify eligible patients more quickly by analyzing medical data.
• Improve real-time participant monitoring, reducing patient drop-out rates during trials.
• Avoid redundant trials thanks to centralized databases, which allow for the reuse of existing data instead of starting from scratch.

A study conducted by Medidata showed that the use of AI-generated synthetic control arms, based on historical data, can reduce the number of required patients by up to 50%, significantly lowering clinical trial costs.

Trial failures represent a massive waste of financial resources. SaaS tools enable faster detection of anomalies, helping avoid unnecessary spending on trials destined to fail. With AI-driven predictive analytics, laboratories can:

• Identify inefficiencies in real time and adjust the trial protocol immediately.
• Reduce the risk of failure in early phases, thereby avoiding the high costs associated with prolonged or poorly designed studies.

Clinical trials often involve expensive logistics, particularly to ensure patient participation and the coordination of investigational sites. SaaS solutions make decentralized clinical trials easier by enabling:

• Remote patient monitoring via mobile apps and connected devices.
• Direct data collection by participants, minimizing the need for clinic visits.
• Simplified management of inventory and supply of investigational drugs.

A document analysis reveals that on-site monitoring—primarily for source data verification—can account for up to 25% of a clinical trial’s total budget. Implementing EDC (Electronic Data Capture) could significantly cut these costs by reducing the need for such on-site checks.

The adoption of SaaS solutions in clinical trials marks a major step forward for the pharmaceutical industry. Not only do they accelerate the time-to-market for vaccines, but they also drastically reduce costs across multiple levels. These innovations allow laboratories to reinvest their savings into new developments, enhancing both the speed and accessibility of vaccines on a global scale.

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