Clinical Trial Software: Innovations Shaping the Future of Clinical Trials

Clinicians looking at a computer with clinical trial softwareA clinical trial is an important component of the drug development and approval process. The data obtained from clinical trials is crucial to meet regulatory compliance, helping to ensure a drug’s efficacy and safety for human use.

With technological advances, clinical trials have become more accurate and streamlined, reducing the risk of drug failure. Clinical trial software and clinical trial management systems such as EDC, eCOA / ePRO, and eConsent have been integrated with clinical trial automation software to collect data at each stage of the studies to improve clinical outcomes.

With growing preferences for integrating technologies in the drug development process, the clinical trial software market size is projected to reach over USD 3,684 million by 2035, according to a recently published report by Roots Analysis. As the technology continues to evolve, the market is expected to witness several innovative trends that are set to revolutionize the future of clinical trials.

These clinical trial software market trends will open several opportunities for the leading players in this industry.

Clinical Trial Software Market Landscape

Given the increasing demand for this technology, the clinical trial software market will witness substantial growth at a high compound annual growth rate (CAGR) of 14% from 2023 to 2035, according to the Roots Analysis report.

Currently, the clinical trial software market features more than 70 clinical trial software companies that develop advanced clinical trial software solutions. Overall, the market is highly fragmented, featuring several industrial and non-industrial leaders who are making considerable investments and entering into collaborations to speed up the development process to meet the growing demand for innovative clinical trial management solutions. It is interesting to note here that North America emerged as the epicenter for clinical trial software companies engaged in the market. As per the study conducted by Roots Analysis, more than 45% of the key industrial players are headquartered in North America.

4 Innovations Shaping the Clinical Trial Software Market

Innovation is the key step towards revolutionizing the clinical trial industry at the global level to benefit researchers. Furthermore, technological advancements also accelerated the development of personalized medicine and enabled remote patient monitoring. These transformative software solutions help to reshape the landscape of clinical studies, improving patient outcomes for all industrial leaders. Some of the innovative trends that are shaping the future of the clinical trial software market include the following.

1. Artificial Intelligence and Machine Learning

Artificial intelligence (AI) and machine learning (ML) are progressively being integrated into numerous processes of drug development, especially artificial intelligence. AI in clinical research can alter clinical trials while also improving the operations of contract research organizations (CROs) and the biotechnology and pharmaceutical industry.

AI-in clinical trials facilitate drug development, speeding up processes, improving clinical trial efficiency, automating testing, and increasing data analysis precision. The algorithm of artificial intelligence helps comprehend complicated data patterns with higher precision.

AI's effect extends to patient recruiting via behavioral analysis on social media platforms and chatbot interactions, which increase trust and enrollment. Artificial intelligence and machine learning will be the top trends in the upcoming years.

The global AI in clinical market is anticipated to grow by USD 8.50 billion in 2035. It is expected to grow at a CAGR of 16% from 2023 to 2035, according to the AI in clinical trial market research report by Roots Analysis.

2. Expanding Decentralized Tools Models

Decentralized trials, often known as remote trials, have reshaped the clinical trials that are conducted for drug development. These tools provide better flexibility and patient-centric studies to facilitate real-time information collection about patients' health metrics. With the development of clinical trial software technologies such as telemedicine, electronic consent, remote monitoring, and AI-based wearable devices, patients can participate in clinical trials remotely without any requirement of frequent visits to physical trial places.

Currently, pharmaceutical companies and contract manufacturing services providers are leveraging decentralized trials to enhance the participation of patients, streamline the trial process, and significantly reduce costs. Currently, clinical trial software market players focus on developing decentralized tools for effective patient care and safety compliance.

3. Wearable Devices for Clinical Trials

Wearable technology such as fitness trackers and smartwatches has become increasingly significant in clinical trials, allowing researchers to collect real-time data on patient behavior and health. Wearable gadgets can help researchers collect critical data for enhancing the efficacy and safety of novel treatments, such as measuring physical activity and monitoring vital signs.

To capitalize on the promise of wearable devices, pharmaceutical companies may enter into collaboration agreements within the clinical trial software market to incorporate wearable device technology into their clinical studies. The ongoing partnerships and increasing trend of integrating wearable devices with clinical trials are driving the market, as per the Roots Analysis report.

4. Risk-Based Quality Management Software 

Risk-based quality management (RBQM) software integration with clinical trials is a proactive approach to maintaining the integrity and quality of clinical trials. With early identification of risk during clinical trials, including data analysis and protocol development, these risk-based quality management tools help to enhance trial quality. The operational flow of RBQM includes risk identification, evaluation, control, ongoing monitoring, and improvement.

This multimodal procedure reduces data mistakes while increasing trial efficiency, resulting in more accurate outcomes. The safety of participants is prioritized, while trial management efficiency is improved. RBQM involves stakeholders, including sponsors, clinical research organizations, researchers, and regulatory agencies, and is tailored to the specific needs of each trial.


With the rise in the availability of advanced software solutions, the clinical trial process has become more streamlined and precise and reduces the time required to compile the documents required for the clinical validation and drug approval process from regulatory authorities such as the FDA. From wearable devices to capture real-time data analysis to decentralized trials to expand patient access, clinical trial software solutions will transform the clinical trial process. The clinical trial software market will unquestionably grow at a steady pace in the future.

For more information, please read the full report from Roots Analysis on Clinical Trial Software Market, which details this market’s unique dynamics, providing insights into the historical period (2022-2023) and forecasting trends for 2023-2035.

About Author

Nancy Kapila is an accomplished pharmaceutical consultant with a rich and diverse experience spanning over five years. Drawing on deep knowledge and expertise, Nancy provides valuable insights and strategic guidance to help clients successfully navigate the evolving pharmaceutical industry and stay at the forefront of the competition.

About Roots Analysis

Roots Analysis is a global leader in pharma and biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists, and strategic investors for more than a decade, Roots Analysis offers a highly analytical and data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by this firm are structured in a way that enables the reader to develop a thorough perspective on the given subject.

Topics: Software & Enterprise Computing Pharmaceuticals Industry Insights