<div id="readability-page-1"><div>                                 <figure>                                                                                                                                                    <img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/AI-data_2607485783_edited-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" width="430" height="241" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/01/AI-data_2607485783_edited-430x241.jpg"/>                                                                          <figcaption>Clinical trials teams must skillfully manage multiple challenges in 2026, but there are opportunities for growth. Credit: via Shutterstock.  </figcaption>                                 </figure>                             </div>                                                     <p>As the clinical trial industry faces key challenges such as shifts, rising costs, and staffing challenges, 2026 is poised to be a pivotal year for teams to find efficiencies through modernizing study processes.</p>                                                       <p>Twelve months ago, we interviewed Jennifer Duff, Executive Vice President and General Manager of Zelta, to discuss what the industry could expect in the year ahead.</p>    <p>Many of her predications hit the mark, from investment headwinds, a rise in full-service outsourcing (FSP) engagements, to improved clarity on effective use cases for wearable technology, and practical deployments of AI. We also saw continued investments in rare disease research that highlighted the need for agile clinical data management platforms to streamline the execution of complex and costly trials.</p>    <p>To better understand the landscape heading into 2026, we spoke with Jennifer Duff again to see what’s on the horizon for the coming year.</p>    <h2 id="h-trend-1-ai-powered-protocol-automation-will-see-accelerated-adoption">Trend 1: AI-powered protocol automation will see accelerated adoption</h2>    <p>Looking back at 2025, Duff noted that despite all the AI hype and investment, mass adoption in clinical trials will only happen where it helps solve the most pressing business challenges. She predicts that we will continue to see use-case led AI adoption as the key to getting return on investment.</p>    <p>One use case where she expects AI adoption to grow in 2026 is in automating the interpretation of clinical protocols and configuring study databases, as well as managing ongoing protocol change. This is traditionally among the most time-consuming steps in trial design.</p>    <p>There are two main aspects of the increased effort to support protocol automation. The first is digitization of trials over paper-based methods. For example, interpreting a PDF or a paper protocol to generate an electronic study build. The second is digitalization, which uses AI tools to write new trial protocols based on electronic historical records.</p>    <p>Not only will AI-powered protocol automation help accelerate clinical development timelines, it will also create standardization and harmonization within a program. Whenever there is a protocol change, teams using the same tooling can view what has changed in the protocol and react accordingly, allowing for more effective impact assessments before implementation.</p>    <p>“It’s going to optimize efficiency, bring down costs and manual effort, and improve traceability and quality. It will also bring together really good science between the human experts and the added controls on the AI side,” says Duff. “There’s a significant amount of investment in it right now. Once we stand up the ability to support ingestion and implementation of this, and integrate with downstream workflows, that adoption will add immediate value.”</p>    <h2 id="h-trend-2-risk-based-validation-will-become-more-prevalent-alongside-traditional-testing-methods">Trend 2: Risk-based validation will become more prevalent alongside traditional testing methods</h2>    <p>As clinical research teams search for efficiencies amid staffing shortages, automating traditional manual testing and validation is another key area of focus and opportunity for AI. There is a clear evolution toward intelligent and risk-focused validation methods that can complement traditional manual testing to maintain compliance while reducing timelines.</p>    <p>It’s clear why this area is ideal for AI adoption. The highly structured nature of manual test scripts and documented workflows provides the necessary foundation for machine learning models to automate these processes while maintaining accuracy.</p>    <p>As with any industry innovation, regulatory compliance and acceptance are crucial. Yet according to Duff, regulators see value in this technology. In fact, Duff anticipates the adoption of these technologies to benefit the entire ecosystem surrounding clinical research.</p>    <p>“The regulatory bodies certainly see the value in this. The manual processes are quite cumbersome. As long as you produce the evidence of high-quality validation and testing, you will meet the regulatory requirements,” explains Duff. “You still have to provide the evidence that it was done properly, but that evidence doesn’t have to be done manually by a human and it doesn’t have to follow the legacy manual processes. It can be produced by the machine. So, there are significant benefits to this.”</p>    <p>Sponsors of all sizes can benefit from advances, and CROs have the capacity to implement risk-based validation into their processes. Zelta is currently running a proof-of-concept to demonstrate the significant value for clinical research teams.</p>    <h2 id="h-trend-3-continuous-trials">Trend 3: Continuous trials</h2>    <p>The announcement from the US FDA about their interest in continuous trials has the potential to radically shift how clinical trials will be delivered in the future.</p>    <p>The intention is to get products to the market more quickly. Instead of conducting clinical trials in phases to obtain regulatory approval for a product, trial participants would receive the treatments over a longer period and have their health closely monitored – potentially over decades. Wearables could play a key role within this, with the US Health and Human Services Secretary stating a long-term goal to have all Americans wearing such devices.</p>    <p>Even though the continuous trials concept is not a new idea, given that the clinical trials industry was built around a phases model and continuous trials have been mostly used as experimental designs to date, a total rethink is required for continuous trials to be successful at scale.</p>    <p>Continuous trials require changes across clinical decision making, trial execution (including at the sites, with patients, and with clinicians), as well as in how protocols are written and data monitored. Other considerations include how sites are chosen, the ways participants engage, how to manage consent for trials, and the research structure.</p>    <p>It remains to be seen whether a large-scale shift to the continuous trials model is viable as there are additional risks with this approach, and it is not fit for purpose for all research needs. That said, continuous trials have been successful and aspects of the approach have already been implemented in adaptive trials, which are now more common in the industry. And it should be noted that technology should not be seen as a barrier as there are existing technology solutions that can handle requirements for continuous trials such as has been done on the Zelta platform.</p>    <p>As the industry looks to new, bolder ways of moving quickly and efficiently, while not sacrificing the quality and integrity of research, adoption of continuous trials approaches makes sense. And with the right technology partners, it is feasible today.</p>    <p>“Where appropriate to do so, there’s a huge amount of value, efficiency, and savings that one gains from conducting trials in this manner,” adds Duff. “The real challenge is on the trial design and execution side.”</p>    <h2 id="h-trend-4-managing-through-uncertainty-regulatory-and-industry-challenges">Trend 4: Managing through uncertainty – regulatory and industry challenges</h2>    <p>With greater levels of uncertainty and the potential for rapid changes to regulations and practices, continuing to navigate these issues will be vital in 2026. Budgets in clinical research have been tight for the last few years, with teams needing to do more with less.</p>    <p>The need for efficiencies and process optimization will be fundamental, with every expense needing justification. But these circumstances also create opportunities for technological innovations and refinements of existing processes.</p>    <p>“The most successful companies are the ones who are going to recognize this is the new normal,” says Duff. “Don’t fight it. Learn to work with it. Make sure you’ve got a good cost base and the right partners so that you’re managing your business well and are a good steward for your employees, and if you’re a public company, your investors.”</p>    <p>Strategic partners with proven adaptability will be of considerable value in this shifting industry environment. Zelta has a reputation in the industry as being transparent and flexible, with a willingness to work with clients to help them achieve their objectives.</p>    <h2 id="h-trend-5-cros-differentiating-in-a-more-competitive-marketplace">Trend 5: CROs differentiating in a more competitive marketplace</h2>    <p>2025 was a challenging year for both CROs and sponsors. As the number of new trial starts slowed, competitiveness increased and continued focus on cost-optimization drove more critical evaluation of partners. Given these pressing challenges, CROs need to be agile to remain competitive.</p>    <p>Looking ahead to 2026, there is a clear focus on maximizing the value of every investment. With operational costs under close scrutinization, CROs need to deliver trials more efficiently. Sponsors are more willing to switch partners than they have traditionally, which is one of the reasons why rescue studies are growing, according to Duff.</p>    <p>Consequently, more sponsors are seeking partners with solid brand reputations in specific research areas. This means CROs will also need to communicate what areas they specialize in more effectively.</p>    <p>“Companies are more willing to switch to reduce risk. We saw an increase in trial movement in 2025”, adds Duff. “In our case, because switching with a SaaS product is easier than some other product constructs, sponsors have a lot more decision-making authority and the ability to switch partners, and switch faster, if they’re finding a partner isn’t working well. It’s important to deliver on your differentiation, be known for something, focus on what is important to your sponsors and clients.”</p>    <p>As we begin 2026, is your clinical research team identifying opportunities for automation to accelerate study timelines? Are you evaluating your processes and partnerships to ensure your business can successfully navigate changing market dynamics?</p>    <p><strong><em>To learn more about how Zelta EDC can help your team confidently deliver clinical trials, download the whitepaper below.</em></strong></p>                                                                                                                   </div>

<p>In 2026, clinical trial teams will face challenges but also opportunities for growth, particularly through AI adoption. Key trends include accelerated AI-powered protocol automation to streamline trial design, increased use of risk-based validation methods alongside traditional testing, and the potential shift towards continuous trials as indicated by the FDA. These advancements aim to enhance efficiency, reduce costs, and improve compliance in clinical research, ultimately leading to faster market access for new treatments.</p>

- The clinical trial industry is facing key challenges in 2026, including rising costs and staffing shortages, but opportunities for growth exist through process modernization.  
- Predictions from industry expert Jennifer Duff emphasize the accelerated adoption of AI for protocol automation and risk-based validation, aiming for greater efficiency and compliance.  
- Additionally, the FDA's support for continuous trials signifies a potential shift in how trials are executed, necessitating reevaluation of traditional practices amidst regulatory uncertainties.

Trends for 2026: Targeted AI, continuous trials, and navigating uncertainty