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Updated on : 08 Aug 2025
Digital transformation in clinical trials has become the cornerstone of modern pharmaceutical research, with reducing the cost of research, reaching a more diverse patient population, monitoring patient safety promptly, and bringing new and novel data sources into trials serving as the primary goals of going digital for all clinical operations teams that strive to achieve operational excellence and enable digital transformation in healthcare.
While most senior leaders from sponsor organizations have a clearly defined vision and strategy for digital transformation in clinical trials, only 30% of the companies have allocated budget to support clinical trial sites with digital technologies. This gap highlights the critical need for comprehensive pharma clinical trials solutions that bridge strategy and implementation.
Digital Transformation in Healthcare: Making Clinical Trials a Digital-First Priority
Technology in clinical trials is revolutionizing how pharmaceutical companies approach drug development. It can reduce trial costs by utilizing fewer physical sites, lowering investigator fees, decreasing patient travel costs, and minimizing site monitoring expenses, all enabled by sophisticated pharmaceutical clinical trials solutions. New technologies are already enabling a shift toward decentralized and virtual trials, improving patient experiences and the overall clinical journey. By supporting both patients and investigators, advanced pharma clinical trials solutions have the potential to significantly reduce the rate of clinical trial failure and lower drug development times and costs, bringing new, improved, and potentially more affordable drugs to the market faster.
Building Digital Expertise in Clinical Trials: The Hybrid Approach
For sponsors, most clinical trials will not be entirely virtual, as they will use one or more decentralized elements suitable for their study. However, it is evident that decentralized trials (DCT) are a part of many life sciences companies' larger R&D portfolio. Developing digital expertise in clinical trials has become essential as life sciences companies have begun to take a hybrid approach to clinical trials and they implement digital technologies for each study based on the design and the feasibility of decentralization for a given therapeutic area.
For instance, post-pandemic Electronic Data Capture (EDC) was the earliest to be widely adopted to expedite the process of data entry and query resolution of Case Report Forms (CRF) at local sites. This was followed by a series of pharma clinical trials solutions to capture data and manage the medical research process from the sponsor, site, and patient perspectives. Below are key technologies in clinical trials solutions currently being implemented:
The technology stack in clinical trials has significantly expanded, embracing advanced digital transformation solutions. Key innovations include the use of Generative AI and Machine Learning for predictive analytics, optimizing patient recruitment, and enhancing protocol design. Digital twin technologies are being leveraged to create virtual patient populations, enabling the simulation and testing of drug candidates before actual trials. Additionally, Generative AI tools are streamlining protocol authoring, regulatory document preparation, and data analysis.
Harnessing Technology to Drive Clinical Trial Efficiency and Innovation
As DCTs are more focused on patients, they offer several benefits to them, such as flexibility with site visits, increased access to clinical trials, and better engagement with research sites and physicians
Digital transformation in healthcare has brought several additional advantages to clinical trials. It has enabled enhanced diversity and representation by extending the geographic reach of studies, allowing participation from a broader and more varied population. AI-driven data analysis and real-time insights have accelerated decision-making processes, leading to more efficient trial execution. Patient retention rates have improved as digital tools reduce the burden on participants and increase convenience. As a result, clinical trial data has become more representative of real-world patient populations, ultimately enhancing the relevance and applicability of study outcomes.
Why Sponsors Must Embrace Digitizing Clinical Trials with Scalable Digital Capabilities
Given all the advantages and the solutions that are being adopted, there is no doubt that clinical trials are one of the functions that have greatly benefited from digitization. Digitizing clinical trials has increased the adoption of telemedicine and various scheduling tools, which help patients actively participate in trials remotely from the convenience of their home or by visiting nearby local micro-sites. In addition, tools such as wearables, sensors, health monitoring devices, and apps enable new ways to capture data and effectively monitor patients' health and engagement throughout the study.
Modern enterprise blueprints now incorporate AI-first architectures that can intelligently connect data, technology, and analytics to optimize trials. These frameworks enable faster decision-making, reduced risk, and accelerated delivery of life-changing therapies to market. Potential issues can be identified much earlier in the trial, and changes can be made to the study as required, by applying modern analytical tools and methodologies to this data. For instance, sponsors can leverage Real-World Evidence (RWE) to design studies, identify and target study sites, and the right cohort of patients, thereby improving trial efficiencies. This information can also be presented on sophisticated dashboards with appropriate built-in alerts, enabling sponsors to adopt a risk-based approach to run clinical trials. AI-enabled solutions eliminate potential problems, shorten trial duration, and enhance accuracy and productivity across the entire clinical development process.
To achieve these outcomes, it is critical for sponsors to develop digital capabilities because once a study is decentralized, there will be many opportunities to capture various types of insights arising from continuous data collection and accordingly use them in the study. This also necessitates sponsors to develop an enterprise blueprint to develop DCT infrastructure so that they can easily add solutions in the future based on the extent of digitization required for specific clinical trial studies.
Navigating the Complexities of Decentralized and AI-Enabled Clinical Trials
While the adoption of digital technologies will continue to increase, the complex ecosystem also presents many challenges to sponsors. Some of the challenges that sponsors need to address are:
Regulatory Momentum and Purpose-Built Technologies Are Fueling Clinical Trial Decentralization
Traditionally the relationship between clinical trials and the real world was mostly one-way. Drugs were developed using a tried and tested methodology and commercialized post regulatory approval. More recently, attitudes have changed and analytical power has increased - both deeper and more complex data sets, and new tools that can analyze the data sets are now available. In parallel, the regulators including the FDA have been accepting the greater use of RWE derived from Real World Data (RWD). As a result, RWD is being used to supplement the data collected during clinical trials and inform protocols and study designs. A parallel development is the use of large RWD sources (for example Electronic Hospital Records) to identify the right target hospitals for specific patient populations.
In the past two years, Regulatory bodies have increasingly embraced AI in clinical trials. The FDA has actively promoted the use of AI for clinical trial design and research, recognizing its potential to optimize dosing regimens, and enhance overall drug development efficiency. This regulatory support also creates a more favorable environment for AI adoption in clinical research further driving digital transformation in healthcare.
Charting the Future of Clinical Trials: A Digital and Patient-Centric Frontier
Given the substantial process improvements and technological advancements sponsors garner with digitization, there is an increasing interest in the value that can be gained beyond this. Talking with our customers, Indegene has seen some common themes emerge on where they believe technology can help them run clinical trials more efficiently. The most common topics discussed are centred on how can sponsors recruit patients more quickly, including the identification/selection of appropriate sites. Services such as hyper-targeted campaigns, personalized virtual interactions, Central Registered Nurse (RN) concierge, home health care, and logistics support, will continue to assist sponsors to optimally digitize clinical trials and improve patient engagement during the entire study.
Whether sponsors decentralize clinical trials for experimental use cases or to shift operating models, factors that drive successful DCTs remains the same - Patient centricity, an array of digital health technologies, data collection and analytics and the leadership’s intent to improve the efficiency of clinical trials to enable safe, effective, and affordable therapies to patients faster.
The convergence of AI, digital twins, and decentralized approaches represents a fundamental shift in how clinical research is conducted. Organizations that embrace this technology revolution will be positioned to deliver breakthrough therapies faster, more efficiently, and with greater patient accessibility than ever before.
As we continue to support the digital transformation of clinical trials, we invite you to connect with us and explore how your organization can lead the next wave of innovation in clinical research.
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