2025: Perspectives and Predictions From Advarra Thought Leaders

2024 has been a year of growth and evolution in clinical research. The coming year is expected to be no different. As we look to 2025, Advarra thought leaders have compiled predictions and perspectives on key topics shaping the industry. These topics include perspectives on how artificial intelligence (AI) will be leveraged in clinical research, key regulatory trends shaping the industry, the movements of site consolidation, the continued challenges (and potential solutions) of study startup, and more.

Prediction Area: Artificial Intelligence

Advarra Thought Leader: Jeff Sidell, CTO

AI in clinical research is poised for significant evolution, driven by advances from organizations like OpenAI and Anthropic. These companies are laying the groundwork for more sophisticated AI applications designed to transform clinical operations, improving both efficiency and productivity. In addition to generative AI, there is promise in predictive analytics, which can leverage historical and real-time clinical operations data to forecast outcomes, optimize resource allocation, and streamline timelines.

AI can also automate labor-intensive tasks, such as extracting key information from protocol documents to populate downstream systems. For example, AI tools can pull data from protocols and automatically update clinical trial management systems (CTMS), reducing manual entry errors and increasing workflow speed. This same data could be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.

Moreover, AI can enhance study design by analyzing past trials and recommending improvements based on data patterns. Site selection will also benefit from AI by identifying optimal sites with a high likelihood of recruitment success, considering factors like demographics, past performance, and patient availability. As AI continues to evolve, its ability to transform the efficiency, quality, and scalability of clinical research will grow exponentially.

Prediction Area: Study Startup

Advarra Thought Leader: Ashley Davidson, VP Product – Sponsor Technology

Clinical research study startup will continue to pose challenges for sponsors as the industry’s tendency to address individual process pain points with focused, siloed solutions persists. While these targeted technologies may offer immediate relief in specific areas – such as site identification, contract management, or regulatory document collection – they often fail to integrate seamlessly with other aspects of the startup process.

This fragmented approach results in inefficiencies and data silos, slowing down study initiation rather than accelerating it.

Sponsors, in pursuit of solving these isolated issues, may overlook the broader need for a more connected and streamlined workflow across the entire study startup process. To truly address the complexity of study startup, a more holistic strategy is needed – one prioritizing system integration and data connectivity. By linking key steps, such as site selection, regulatory submissions, and contract negotiations, sponsors could improve transparency and reduce redundancies.

The future of study startup will likely involve an increasing recognition of the value of connected systems enabling real-time data sharing and decision making. However, achieving this vision will require a shift from focusing solely on fixing individual pain points to building a unified, interoperable framework to bring together data and processes across the study startup ecosystem.

Prediction Area: Regulatory

Advarra Thought Leader: Julie Ozier, SVP Global Review Regulatory

Regulatory bodies, particularly the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), will continue to drive harmonization in the clinical research industry. Over the years, these agencies have made significant strides in aligning their rules and guidance, as seen with the harmonized definition of an institutional review board (IRB), informed consent, and the recent implementation of the single IRB (sIRB) model. This push for consistency aims to streamline regulatory processes and reduce administrative burdens for sponsors and researchers.

As the harmonization effort advances, the focus will likely shift toward refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners. These groups require special protections in clinical trials, and aligning regulations across agencies will simplify the ethical review and approval process for studies involving these populations. This consistency will enable more efficient trial oversight while ensuring the highest standards of protection for vulnerable participants.

Continued harmonization will not only ease the regulatory burden but also facilitate faster study initiation and improve compliance. It will foster a clearer, more unified regulatory framework, reducing confusion for sponsors and researchers, ultimately enhancing the inclusivity and efficiency of clinical research involving vulnerable groups.

Prediction Area: Increased Site Consolidation

Advarra Thought Leader: Christine Senn, SVP Site/Sponsor Innovation

After a year of site consolidation slowing down due to difficult times for most independent sites from Q3 2023 to present, 2025 will see an upsurge in consolidation.

There are varied opinions about site consolidation, but I would like to add some perspective: Pharmaceutical companies routinely buy up small pharmaceutical and biotech companies and add them to their portfolio. Contract research organizations (CROs) only came into existence in the 1980s and were, by default, all small when they started; consolidation brought us the large CROs we know of today and are used for global trials. Hospital systems built up smaller, independent hospitals and independent regional clinics, all in the hopes of improving profit margins by consolidating centralized operations – which has the goal of keeping these clinics and hospitals in business in order to reach more patients.

Site consolidation is much the same. It has its pros and cons, but I will speak to the positives of such consolidation. They are, of course, similar to the reasons all the businesses just mentioned aim to consolidate. First, in nearly any business in any industry, staying afloat financially is difficult. Consolidating resources and streamlining processes can improve profit margins, which can keep businesses afloat longer.

Second, there will always be some locations or business arms not doing well financially. In the case of clinical research sites, no sponsor wants to see a site close while they are in the middle of a trial. Being part of a larger network, the network is able to provide resources to stay afloat and continue doing research even while losing money. This is also true of academic medical centers, which often see their research activities losing money while the other business lines are able to keep this important endeavor afloat. It is often critical to conduct research without much, if any, profit.

Third is a related topic. As we approach a crisis of a lack of principal investigators and have become increasingly acutely aware of inadequate diversity and clinical trial enrollment, opening new sites is paramount to helping the industry as a whole. Again, a site network has the ability to help keep a new site bankrolled. In my experience, a new site is likely to lose money for up to a year.

Fourth, consolidation at a global level can improve trial enrollment and efficiency. There are many ways in which being a small biotech company, small CRO, or individual site is absolutely wonderful for this industry. At the same time, we know global sponsor companies and global CROs offer unique benefits in reach, understanding country-specific regulations, having staffing already onsite in various locations, etc. Global site networks offer a similar benefit.

Prediction Area: Industry Standards

Advarra Thought Leader: Elisa Cascade, Chief Product Officer

The increasing complexity of clinical research studies will continue to have far-reaching implications, particularly in terms of cost and efficiency. As protocols grow more complex, the associated cost to operate these studies rises at a time when sponsors are under pressure to manage expenses while also accelerating the pace of research. This tension between cost containment and speed to market highlights the need for innovative solutions to streamline processes and consolidate technology systems all without sacrificing quality.

One promising approach is the adoption of industry-wide standards which open the door towards greater connectivity and a digitized data flow. For example, use of a common protocol template can drive consistency and efficiency, reducing the time and effort needed for study design and technology setup. Standardization also simplifies integration between site and sponsor technology systems, enabling all users to operate in their system of choice and data and documents to flow throughout the connected ecosystem.

While the industry will continue to identify opportunities for standardization, implementing these standards will remain a challenge. Diverse stakeholders, competing priorities, the need for change management in large, conservative, process-driven organizations, and in some cases, older, monolithic technology can all slow down progress. To realize the full benefits of standardization, the industry must work collaboratively, overcoming hurdles in adoption and ensuring new standards are embraced and applied consistently across all phases of clinical research.

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