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The organizations that benefit most from AI won't be the ones with the newest platforms or biggest tech budgets. They'll be the ones who already did the hard work of connecting research to healthcare and building real trust with patients and communities. Read on to see why the future of AI in clinical research depends less on the tools and more on the foundation you build before you use them.
That gap between "documented" and "prepared" isn't a training failure. It's an operational one, and it's costing sponsors time, compliance, and site goodwill. This whitepaper breaks down why the training model most sponsors rely on can't meet what ICH E6(R3) now expects, why legacy LMS platforms and CRO-delivered training can't close the gap, and what a sponsor-owned approach looks like when it works. Read on for proof points from sponsors who've already made the switch.
More complexity. Same expectations. Less time for patients. That's the reality facing research sites today, and it was front and center at SCRS West. This article breaks down what site leaders had to say about capacity, patient support, and what real operational relief actually looks like.
The sites that recruit best aren't necessarily the ones with the biggest database or budget. They're the ones that turn people, processes, and partnerships into a single working system. This article breaks down how to build that system, from cross-functional collaboration to long-term physician partnerships to using data without needing fancy tech. Learn how your site can turn independence into your biggest recruitment advantage.
Participants call the site when payments, travel, or support requests stall, even when another provider owns the answer. This article examines why vendor handoffs so often return to coordinators, what a usable handoff needs to transfer, and what sites should ask before enrollment begins.
Sites are not facing a single AI governance challenge. They're facing two simultaneously — and they have almost no infrastructure for either. On one side, sponsors and CROs are pushing AI tool adoption at an accelerating pace, often without providing sites the training, validation guidance, or vendor standards needed to use those tools responsibly.
Four organizations share how they've meaningfully cut redundant site training burdens through role-based assignments, on-demand guidance, and intuitive design — all without compromising compliance. Their shared takeaway: training should enable performance, not create a paper trail.
Traditional budget models haven't kept up with the realities of modern trial execution. Sites absorb hidden costs that sponsors don't account for, leading to adversarial negotiations, delayed startups, and strained resources. Forward-thinking sponsors are changing that with technology fees, contingency funds, and a genuine effort to understand what sites actually need.
Most studies have support resources in place, but sites often don't know what's available or how to access it. When support stays invisible, manual workarounds take over and burden shifts back to already-stretched teams. Visible, easy-to-use support benefits sites and participants alike.
Mobile tools add real value for short, time-bound actions like approvals, sign-offs, and safety notifications — but mobility rarely means mobile-only. New efficiency gains come with new governance questions around auditability and accessibility. The biggest wins come when mobile design respects the realities of busy clinical environments.
Dropout rates of 30–40% are common in cardiometabolic trials, yet retention is still treated as a downstream problem rather than a design decision. The real drivers — visit burden, logistics, side effects — are predictable, which means they're preventable. Until trials are designed around how participants actually live, the enrollment-to-completion gap will persist.
Digital tools are reshaping clinical trials, but they can't eliminate every barrier patients face. Sites absorb the friction between protocol design and patient reality daily. Making trials truly accessible requires pairing technology with human-centered support.
Study delays, holds, and cancellations increased 105% in 2025 compared to 2024, representing one of the most significant operational challenges facing research sites today. These disruptions extend beyond sponsor and CRO impacts. Research sites face substantial financial losses, operational setbacks, and reputational damage. Sites invest significantly in staffing, infrastructure, and study preparation, yet often receive no compensation for rework, retraining, or refreshing costs when studies are delayed or cancelled. The consequences compound beyond immediate financial impact. Sites experience erosion of trust with referral sources and community partners. Participants lose momentum and confidence in both individual sites and the broader clinical trials industry. Rebuilding this trust requires considerable time and resources. Strategic Risk Management for Sites While no single indicator perfectly predicts study disruptions, sites can implement proactive risk assessment strategies to protect their operations and patient populations. This comprehensive guide provides actionable strategies developed by large, sophisticated research site networks, including: Financial vetting methods for sponsors and CROs Key risk indicators to monitor throughout study lifecycle Operational strategies to minimize financial and reputational exposure Best practices for maintaining stakeholder relationships during disruptions Download the guide to access evidence-based strategies for navigating study disruptions and building operational resilience. Download
In recent years, a concerning trend has emerged in the clinical research industry. Some sponsors and Contract Research Organizations (CROs) are attempting to extend site payments to quarterly schedules and withholding a percentage of payments until the completion of a study. This financial strategy impacts clinical research sites significantly, and understanding these implications is crucial for making informed business decisions. David Vulcano, Honorary President of the Society for Clinical Research Sites, highlights this issue, emphasizing that while many sponsors and CROs offer timely resources to sites for their studies, others are testing the waters to see if sites will accept delayed payments. Unfortunately, some sites are yielding to this pressure. This situation is troubling because sites incur costs as they conduct research, and delayed payments can result in strained operations and decreased study performance. Impact of Quarterly Payments Under typical monthly payment terms, sites receive compensation for work done in a specific month by the following month, maintaining a steady cash flow. However, with quarterly payments, sites must wait several months before receiving payment for services rendered, which can extend the accounts receivable period from an average of 45 days to 137 days. This delay could jeopardize a site’s ability to maintain smooth operations, as funds that could be immediately reinvested into ongoing work are instead left sitting in a sponsor or CRO’s bank account, accruing interest for them. The Holdback Conundrum In addition to the delay created by quarterly payments, some sponsors and CROs implement a holdback policy, where a portion of the site’s earned money is withheld until the end of the study. This amount, often around 10%, prevents sites from utilizing their full resources during crucial times of study execution. The holdback approach means sites may be forced to navigate studies without adequate cash flow, thereby impacting the quality and efficacy of the research conducted. Financial Impacts of These Payment Terms Both quarterly payments and holdbacks bear significant financial impact. As stated in our case study, quarterly payments could lead to financial resources of an estimated $100,000 disappearing due to inflation over the course of the study. Holdbacks, when compounded over time, further increase this financial erosion, with sites potentially losing out on over $169,000 in our case study. This results in resources that were earned by the site and, if paid timely, would have supported continued study operations but they simply vanished from solely due to the unfavorable payment terms. Strategies to Combat Financial Strains Financial literacy, specifically in areas like Excel’s Present Value and Future Value formulas, can assist sites to better understand the negative impact these payment terms have on their study resources. However, even with employing cost-of-living adjustments and interest clauses on the delayed payments, it still does not compensate for the loss of adequate cash flow during the study. In other words, even if the site is made whole in the end, inadequate cash flow is still an under-resourcing of the study. The Bigger Picture Ultimately, this is not merely a matter of budget and terms but speaks to the broader topic of study and site optimization. Studies thrive when sites are financially supported promptly, which ensures resources are focused on the research itself rather than on survival tactics. Collaboration between sponsors, CROs, and sites with equitable and timely payment terms serves the best interest of all parties and promotes the ultimate goal of advancing clinical research. While understanding the temptation to employ such financial strategies, he emphasizes the importance of openness, collaborative negotiation, and fairness in agreements. With mutual respect and understanding of these financial dynamics, all stakeholders can better ensure the success and integrity of clinical research studies. Payment terms should align with the principle of supporting research sites—you must pay when it’s earned and in full. By addressing these financial issues, the clinical research community can work together to create a sustainable, thriving ecosystem that benefits researchers, sponsors, and, ultimately, patients worldwide.
This year's SCRS Global Site Solutions Summit celebrated the people and organizations driving clinical research forward. From groundbreaking operational solutions to transformative leadership and measurable impact on patient outcomes, the award recipients represent the best of what collaboration, innovation, and commitment can achieve. These are the organizations and leaders setting the standard for what's possible...
