CDS Medical Decision Support Systems

2025

Global Electronic Clinical Solutions Market Size Reaches $12.23 Billion

In 2025, costs in the global electronic clinical solutions market amounted to $12.23 billion. More than 40% of this amount fell on the North American region. Such data are provided in a Fortune Business Insights study, the results of which were published on January 22, 2026.

Electronic Clinical Solutions (eClinical Solutions) are specialized digital platforms and software designed to automate, optimize and manage data in clinical trials. They replace paper-based methods of information collection, ensuring speed, accuracy, and compliance. These tools, in particular, are widely used in the pharmaceutical and biotechnology industries to effectively manage complex clinical trials.

One of the drivers of the market is the desire to improve research efficiency. The need to reduce the time and cost of clinical trials drives the implementation of advanced systems such as Electronic Data Collection (EDC) and Clinical Data Management (CDMS). The expansion of the industry is also facilitated by an increase in the complexity and number of clinical trials. Increasing the amount of data collected and the need to comply with strict regulatory regulations require automation with modern digital tools. Using eClinical solutions accelerates information processing and improves process efficiency.

The report's authors point to a shift toward decentralized and hybrid clinical studies. The use of digital tools for remote data collection reduces the need for visits to specialized centers and increases their involvement. There is a growing demand for cloud platforms that provide flexibility, scalability, and remote access to clinical data. The introduction of cloud technologies eliminates the need to invest heavily in the development of local infrastructure - the purchase of servers, storage systems, network equipment, etc.

Analysts note that significant market opportunities open up the introduction of artificial intelligence in clinical research. Neural networks are able to automate time-consuming tasks, such as analyzing large amounts of information, prioritizing requests, classifying documents and identifying anomalies. This significantly increases the performance of clinical operations.

Restraining factors are the problems of interaction between different systems and the fragmentation of data: this is due to the use of fragmented workflows and duplication of information entry. Issues of cross-border information transfer can create additional difficulties.

In 2025, the largest share of revenue was provided by electronic data collection (EDC) - 22.5%. Cloud platforms led the way in the deployment model. Geographically, North America dominates with 42.2%, or $5.16 billion. Major industry players on a global scale are:

• Veeva Systems;
• Dassault Systemes;
• Oracle;
• Iqvia;
• Signant Health;
• Clario;
• Medable;
• Medrio;
• Florence Healthcare;
• Advarra.

In 2026, the volume of the market in question is expected to reach $13.88 billion. At the same time, the United States will have $5.41 billion, Britain - $0.83 billion, Germany - $0.76 billion, China - $0.98 billion, India - $0.51 billion. Fortune Business Insights analysts forecast a CAGR of 14.06% going forward. As a result, costs could increase to $39.75 billion by 2034^[1]

GOST for AI-system of medical decision-making approved in Russia

At the end of October 2025, GOST R 72313-2025 "Systems for supporting medical decision-making using artificial intelligence to extract data from unstructured medical records was approved in Russia. Methods for generating a dataset for training and testing. Quality assessment metrics. " Read more here.

2017: Draft FDA Guidance

On December 11, 2017, the United States Food and Drug Administration (FDA) issued a new draft guideline for evaluating medical devices and physician decision support systems (CDS) in response to changes in relevant regulations.

Under amendments in federal law passed in December 2017, some software features were removed from the definition of "medical devices," and therefore no longer subject to FDA oversight. These changes are incorporated into the new draft guidance.

Draft guidance created for IT systems to support medical decision-making

Devices designed solely for transmission, storage, format conversion, or display of medical examination data and results are no longer medical devices and must not meet FDA requirements. However, programs that analyze or interpret medical data remain under regulatory oversight by the FDA. This amendment will probably not be of great practical importance, since the FDA back in 2015 abandoned increased control over such devices.

The regulator's document also contains updates on mobile medical applications. Now mobile applications that display medical images learned directly from the image transmission and archiving system fall under the selective application of the law, that is, the FDA decides at its discretion when it will resort to appropriate enforcement measures. All mobile applications that are not designed for diagnostic image analysis are now not considered medical devices.

The amendments also affected the systems for supporting medical decision-making. The programs used to prescribe imaging studies now do not fall under the definition of a medical device and are no longer under FDA control. However, programs designed to receive, process, or analyze medical images/signal from the diagnostic system will continue to be treated as medical devices and must meet FDA requirements.^[2]

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