Sponsors are raising their expectations for clinical research sites to deliver higher levels of efficiency, data integrity, compliance, and patient engagement. With advancements in eClinical technology, increasing regulatory demands, and a growing focus on diversity and hybrid trials, the bar for site performance has never been higher. Several key trends are shaping these expectations. From adopting purpose-built technology, to standardizing workflows, and fostering stronger patient relationships, the future of clinical research depends on how well sites adapt to the changing needs of sponsors and the industry as a whole. In this post, we’ll explore what sponsors expect from clinical trial sites in 2025 and the opportunities for sites to excel.
Here are five key areas where sponsor expectations are rising:
1. Emphasis on Diversity and Inclusion
Regulatory bodies, such as the U.S. Food and Drug Administration (FDA), are urging sponsors to implement Diversity Action Plans to ensure clinical trials reflect diverse populations. The FDA Diversity Action Plan is part of broader efforts to modernize clinical trials, improve public trust in medical research, and reduce health disparities. This guidance includes setting specific enrollment goals based on age, ethnicity, sex, and race, and outlining strategies to achieve these goals.
For sites, this means developing a strategic recruitment approach that actively engages underserved communities, forming partnerships with local healthcare providers and advocacy organizations, and leveraging technology to build trust and awareness.
Trends Driving This Expectation
- Guidance from agencies like the FDA stresses the need for diversity action plans in clinical trials. These initiatives aim to ensure broad representation and equitable outcomes for all populations.
- A growing consensus on the moral responsibility to include diverse populations in research. Historically underrepresented populations are often overlooked in clinical trials, leading to disparities in treatment effectiveness and outcomes.
- Organizations are actively promoting tools and strategies to foster inclusivity in research.
Tips for Improvement
Targeted Recruitment Strategies: Build recruitment strategies that target underrepresented communities. For instance, Cedar Health Research (CHR) recently demonstrated a successful approach during a recent event. Leveraging a revamped patient recruitment strategy, CHR targeted diverse audiences with culturally relevant outreach while utilizing RealTime-SOMS, a fully integrated eClinical platform, which allowed them to improve patient engagement. CHR’s efforts resulted in 40 complete patient profiles and eight scheduled pre-screening visits from a single event, showcasing how targeted strategies and advanced technology can effectively reach and engage underrepresented communities.
Community Partnerships: Partner with community organizations and local healthcare providers to build trust, improve access to trials, and increase patient engagement. For example, EmVenio Research has successfully leveraged community partnerships to increase diversity in their clinical trials. By strategically placing their scalable network of clinical trial sites in underrepresented and trial-naïve areas, and collaborating with local hospitals, EmVenio minimizes barriers such as travel and scheduling challenges. This approach improves accessibility, and strengthens community trust and engagement, thus creating a foundation for more inclusive and representative clinical research. Sites can draw inspiration from these strategies to build meaningful connections and broaden trial participation among diverse populations.
Leveraging Patient Engagement Platforms: Technology can be a powerful tool for effectively engaging diverse populations, breaking down barriers to participation, and ensuring that clinical trials are inclusive, seamless, and representative of all communities. eConsent, for example, simplifies the consent process by providing participants with clear, accessible information about the trial in multiple formats, such as videos, visuals, and interactive guides. This improves participant understanding, reduces confusion, and builds trust in the process, encouraging more participants to enroll. Patient engagement platforms, like the MyStudyManager Participant Portal, further improves the participant experience by offering automated reminders, notifications, and easy access to trial updates. Altogether, these features keep participants informed and engaged throughout the study. This engagement powerfully improves retention rates and fosters stronger long-term relationships between sites and patients.
2. Data Integrity, Transparency, and Real-time Reporting
Data integrity and transparency will be at the forefront of sponsor expectations in the coming year. High-profile incidents such as the 2024 Cassava Sciences investigation and the enduring lessons from the Vioxx controversy have spotlighted the critical need for accurate, transparent reporting in clinical research. Sponsors increasingly value sites that can deliver transparent reporting and up-to-the-minute insights. These capabilities reduce delays, improve efficiency, and better safeguard patient safety.
By centralizing information and standardizing workflows with purpose-built eClinical solutions that support real-time data collection, validation, and reporting, sites can effectively align with these sponsor expectations. This approach positions them as indispensable partners in clinical trials. Moreover, sites that excel in this area will set themselves apart as leaders in an increasingly data-driven clinical trial landscape.
Trends Driving This Expectation
- Trials are growing in scale and sophistication, with hybrid and decentralized models becoming more common. Thus, the need for accurate, real-time data has intensified.
- Real-time reporting allows sponsors to address issues like protocol deviations or recruitment bottlenecks more efficiently. Agencies like the FDA and EMA are placing greater emphasis on transparency and data integrity, requiring sponsors and sites to ensure comprehensive reporting and validation processes.
- With rising costs in drug development, real-time data access reduces delays and optimizes resource allocation throughout the trial lifecycle.
Tips for Improvement
Strengthen Compliance and Audit Readiness: A centralized eClinical solution, like eSource, reduces protocol deviations and simplifies data validation. By ensuring accurate and real-time data collection and reporting, sites can mitigate FDA audit risks, strengthen compliance, and demonstrate operational excellence to sponsors.
Leverage Advanced Business Intelligence Tools: Sponsors value sites that deliver data-driven insights to support trial efficiency and outcomes. Business intelligence solutions, like RealTime-Devana, feature data visualization and reporting capabilities that transform raw trial data into actionable insights. These dashboards and reports can provide primary decision-makers with clarity on key metrics such as recruitment progress and site performance.
Highlight Key Metrics with Advanced Analytics: Build trust with sponsors by implementing systems that provide complete visibility into trial progress and performance. Leverage key performance indicators (KPIs) to showcase areas of success and identify opportunities for improvement. By emphasizing the value of real-time reporting and business intelligence, sites can demonstrate their ability to deliver high-quality results.
3. Strengthening Sponsor-Site Relationships
Operational efficiency is increasingly defined by a site’s ability to demonstrate clear, measurable metrics that align with sponsor expectations. Sponsors are seeking sites that can provide transparent insights into key performance indicators such as enrollment rates, protocol adherence, and study timelines. The ability to track, validate, and present these metrics in real time not only enhances trust but also positions sites as reliable, data-driven partners.
Sites that leverage advanced eClinical solutions can efficiently collect and analyze performance data, offering sponsors a clear view of their operational readiness and overall performance. By showcasing specific metrics, sites can differentiate themselves in a competitive landscape. Importantly, this demonstrates a site’s value as an indispensable partner. Finally, sites that build strong trust and foster collaboration with sponsors are better positioned to secure repeat business and strengthen their reputation in the industry.
Trends Driving This Expectation
- CROs add a layer of cost to the trial process, but sponsors are increasingly recognizing the value of building direct partnerships with clinical research sites.
- Sponsors are looking to reduce expenses. Hence, they will establish more oversight and control over the site selection process by bypassing CROs and handling site selection and feasibility assessments in-house.
- With advanced analytics tools and performance-tracking platforms, sponsors can precisely evaluate sites based on specific metrics like enrollment rates, protocol adherence, and timelines.
Tips for Improvement
Demonstrate Metrics Transparency with Technology: Sites can leverage platforms like Devana and RealTime-CTMS to provide sponsors with real-time dashboards showcasing key performance indicators such as enrollment rates, protocol adherence, and timelines. Transparency builds trust and positions your site as a reliable partner.
Site Selection and Feasibility Processes: Adopt performance tracking tools or strategies to present comprehensive data that highlights your site’s capabilities. Also, upgrading from disparate systems to a single, integrated eClinical solution, such as RealTime-SOMS, streamlines workflows, reduces redundancies, and ensures data consistency across all trial activities. This positions your site as a cost-effective and efficient option for sponsors.
Optimize Enrollment Processes: Use advanced analytics to identify bottlenecks in enrollment and develop strategies to address them. Show sponsors how your site proactively manages recruitment challenges to keep trials on track.
4. Technology Adoption
The clinical trial industry is undergoing a digital transformation, and sponsors are increasingly expecting sites to adopt eClinical solutions that advance trial efficiency and outcomes. The FDA has echoed this push, actively encouraging the adoption of innovative tools and decentralized trial designs to modernize clinical research. The agency’s guidance on decentralized clinical trials (DCTs) and digital health technologies (DHTs) underscores the growing importance of tech-enabled trial management.
Tech-enabled sites leveraging tools like CTMS, eReg/eISF, eSource, and patient engagement platforms consistently outperform those relying on redundant, error-prone manual workflows. These technologies offer greater efficiency and accuracy, making tech-savvy sites even more attractive to sponsors. Moreover, sponsors are prioritizing sites capable of conducting hybrid or fully decentralized trials. This patient-centric approach is aimed at expanding trial accessibility and improving participant retention.
Trends Driving This Expectation
- The use of AI to accelerate clinical trials by managing tasks such as protocol writing, patient recruitment, and data analysis.
- Increased focus on hybrid and decentralized trial designs.
- Growing demand for efficiency, accuracy, and scalability in trial operations.
- The push for patient-centric approaches that improve accessibility and engagement.
Tips for Improvement
Streamlined Data Management with CTMS: Use CTMS to consolidate trial operations, including schedules, budgets, and milestones, ensuring seamless data management across complex, multi-site trials. Real-time dashboards provide immediate insights into trial progress, enabling faster decision-making for sponsors.
eReg/eISF for Audit-Ready Compliance: Consider implementing eReg/eISF systems to centralize regulatory documents and maintain detailed audit trails, ensuring full traceability and compliance with regulatory standards. Automated notifications and document tracking reduce the risk of non-compliance and streamline regulatory processes.
eSource for Real-Time, Accurate Data: Leverage eSource to capture data directly at the point of care, minimize transcription errors, and ensure clean, real-time data for analysis. Sponsors gain instant access to validated data, improving their ability to make informed decisions quickly.
Devana for Performance Insights: A platform that organizes study start-up, pipeline management and business intelligence, like RealTime-Devana, gives site leaders the ability to provide sponsors with real-time visibility into key performance metrics like enrollment rates and timelines. Sites can establish themselves as top performing sites with sponsors by sharing data-driven insights that demonstrate site performance, history, and progress. Use real-time dashboards to monitor key indicators like patient enrollment and protocol deviations. Devana’s capabilities in tracking and managing trial performance from start to finish enable sites to provide sponsors with real-time visibility into critical metrics such as enrollment and timelines.
5. Site-based Technology
The clinical trial landscape is shifting as sponsors aim to reduce the need to provide sites with technology and instead seek sites that already have robust, validated systems in place. This trend, driven by operational efficiency and cost containment, highlights the importance of site-based technology that integrates seamlessly with sponsor systems. Sites with advanced eClinical platforms, such as CTMS, eSource, and eReg/eISF, are increasingly preferred partners because of their demonstrated ability to streamline workflows, improve data integrity, and provide real-time reporting without relying on sponsor-provided tools.
Trends Driving This Expectation
- Sponsors are looking to minimize expenses by partnering with sites that have the necessary infrastructure, eliminating the need to invest in or maintain sponsor-provided technology. Sites with interoperable systems ensure seamless data exchange, allowing sponsors to access real-time insights without additional integration challenges.
- Having pre-validated systems reduces trial start-up times, enabling sponsors to initiate studies faster and meet critical timelines. Sponsors are embracing the BYOT model, where sites use their preferred tools, ensuring familiarity, compliance, and efficiency while reducing the learning curve for new systems.
Tips for Improvement
Invest in a Comprehensive Tech Stack: Build and integrated ecosystem with centralized eClinical solutions into your clinical trial management strategy. Consider adopting and combining eSource, CTMS, eReg/eISF, and participant engagement systems into a single, unified platform, like RealTime-SOMS, to reduce redundancies and simplify workflows. Streamlined workflows allow sites to allocate resources effectively, improving both cost management and trial outcomes.
Leverage Bring Your Own Technology (BYOT): BYOT is an innovative approach where sites use their own preferred, validated systems for clinical trial site management. This approach demonstrates a site’s ability to independently manage studies end-to-end and boosts success by maintaining the unique workflows and processes that sites have developed over time. By leveraging BYOT, sites can showcase its capacity to handle every aspect of trial management, from recruitment and data collection to regulatory compliance and reporting, without relying solely on sponsor-mandated systems. In an increasingly competitive landscape, sites that demonstrate their ability to manage trials using cutting-edge technology stand out as reliable and innovative partners. BYOT positions sites as forward-thinking leaders, ready to meet sponsor expectations and delivering superior outcomes.
Final Thoughts
Meeting the rising expectations of sponsors in the years to come will require a proactive approach that embraces modern technology and empowers teams to excel. By aligning with sponsor priorities and investing in scalable solutions, clinical research sites can position themselves as indispensable partners in the clinical trial ecosystem. This commitment strengthens site-sponsor relationships and ensures that research can be conducted with the speed, accuracy, and compliance needed to improve patient outcomes. Sites that rise to the challenge will not only meet sponsor expectations but exceed them.
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