Agenda

AI Basics: Real-World Site Application

Move beyond theory to practical AI implementation. This introductory session showcases real-world AI applications transforming daily site operations. Sites will share case studies sharing how to implement digital tools for protocol review, amendment comparison, patient recruitment, data management, feasibility analysis, and workflow optimization. Understand how AI augments staff capabilities, identify which applications make sense for your site’s size and resources, and navigate the overwhelming number of options.

Developing Tomorrow’s Investigators

The investigator pipeline is shrinking while trial complexity rises. This panel explores how sites, sponsors, and academic partners are preparing the next wave of investigators through early exposure, mentorship, and practical training. Learn what’s working, where gaps remain, and how to advocate for inclusion of emerging investigators and new sites in feasibility and site selection. Discover strategies for building a sustainable, diverse investigator workforce while addressing sponsor concerns about research-naïve PIs.

Global Advantage: International Site Positioning

International sites face unique visibility challenges in global clinical research. Learn how sponsors make geographic selections and how to position yourself based on regional strengths. Identify your competitive advantages in therapeutic areas, disease prevalence, and regulatory environments, then apply “fit for purpose” positioning that matches your strengths to sponsor needs. Regional leaders will discuss how to use global networks with intent, translating cross-regional relationships into measurable value and visibility.

If Only You Knew: Building Stronger Partnerships

Ever wish sponsors understood your constraints? Or wondered why CROs can’t be more flexible? Each stakeholder faces unique realities that shape how trials unfold, but these aren’t always visible across partnerships. In this candid session, representatives from each group reveal what they wish others knew: outdated rules they’re forced to follow, internal advocacy required for timeline shifts, budget constraints that limit flexibility, and wins after perspectives aligned. After honest dialogue, mixed breakout groups will tackle real scenarios, moving from understanding to co-creating actionable solutions.

Mastering Budget Negotiations: Fair Market Value

Learn clinical trial budget negotiation from the site perspective. This fundamentals-focused session breaks down what successful sites negotiate, how to calculate and justify fair market value, which expenses belong in budgets, and strategies for securing favorable payment terms. Experienced site representatives walk through line-item components, overhead allocation, and current market rates, providing honest guidance on what to ask for and how much. Learn how strategic questioning creates efficiency throughout negotiations and how to advocate effectively while building collaborative relationships.

Myth Busters: GCP R3 Implementation

GCP R3 confusion persists about requirements versus sponsor and CRO interpretations. This session addresses implementation challenges including training requirements, PI oversight, and misinterpretations that delay activation. Learn to distinguish between actual R3 requirements and myths with strategies to push back confidently with regulatory support. Sites with documented SOPs share how they defend their approaches.

Patient Recruitment Tools: One Size Doesn’t Fit All

There’s no universal recruitment playbook. This session focuses on matching recruitment tools and tactics to your site’s capabilities and study-specific needs: when to deploy in-house strategies versus engaging external companies, and how to leverage AI-powered patient matching, social media, prescreening, and other specialized tools. Learn to assess which tactics fit your patient population and resources, present your recruitment plan to sponsors to secure support, and align expectations for successful deployment.

The New Site Playbook: From Zero To First Study

A comprehensive roadmap for new sites navigating their first 1-3 years in clinical research. Learn how to build credibility from scratch, secure that critical first study, develop efficient operations and quality infrastructure, and create sustainable financial models. This session provides proven strategies for business development, financial planning, and leveraging your unique advantages as a new entrant in the clinical research ecosystem.

Debunking The Myth: Sites Don’t Want It!

“Sites don’t want eConsent.”
“Sites don’t want central recruitment.”
“Sites don’t want patient concierge services.”

This session challenges common myths about what sites will accept, showing that sites often say yes when solutions are well designed, properly trained, and tailored to real workflows. This discussion reveals why sites accept or reject offerings and what changes the outcome. Sites will learn how to push back or redirect resources, while sponsors and CROs understand the value of asking instead of assuming.

From Feasibility to First Choice: What Sponsors Really Want

Sponsors pull back the curtain on site selection. This candid panel reveals what truly drives their decisions beyond enrollment numbers and therapeutic experience. Hear real examples of what works, common red flags that eliminate sites from consideration, and the specific feasibility indicators that influence awards. Learn what “study-ready” actually means and how to build trusted relationships that lead to increased study opportunities.

Future-Proofing Your Site: Forecasting & Resilience

Build a proactive strategy that protects your site against market volatility and unexpected disruptions. Learn to track the operational and financial metrics that predict future capacity: backlog health, feasibility volume, pipeline velocity, and activation timelines. Identify early warning signs of declining opportunities, develop response strategies that protect revenue and staffing, and make data-driven decisions about resource allocation and therapeutic diversification. Leave with practical tools for scenario planning and long-term resilience.

Leading With Culture: Building Strong Teams

In high-stakes environments, culture isn’t optional. It’s essential. Clinical research often focuses on the technical (SOPs, monitoring reports, regulatory timelines), but culture truly powers our work. Discuss how to intentionally build teams where people are engaged, collaborative, and connected to the mission. Learn how culture differs across site sizes, how to create career development pathways and recognition programs, and how to manage external pressures from sponsors and partners while maintaining internal morale.

Protocol Pressures: Understanding The Site Burden Index

Trials grow more complex while site resources stay stretched. This session explores the Site Burden Index, a quantifiable framework that measures operational demands protocols place on sites by considering site, clinical, data, and technology pressures. Calculate your capacity tolerance and realistic caseload limits, then use this common language for data-informed conversations with sponsors and CROs. Move from anecdotal complaints to structured dialogue: identify pressure points early, assess workload using practical tools, and develop strategies that improve execution for everyone.

Regulatory Readiness: FDA Inspections

The best time to prepare for an FDA inspection is before you need one. This comprehensive session covers inspection triggers, quality management systems, documentation organization for efficient retrieval, staff training, internal audits using practical checklists, and how to respond during actual inspections. As sites adopt AI and technology-driven processes, learn about inspection outcomes for paperless systems, timestamps, and digital workflows. Walk away with your own internal QA checklist and strategies from sites that successfully navigated inspections.

Retention Strategies To Keep Patients Connected

As trials grow more complex and decentralized, sites must rethink participant engagement models. This session explores strategies to sustain participation: building staff rapport, managing retention barriers proactively, accessing tools like home care and telemedicine, and gaining sponsor or CRO support for patient needs. Learn retention success examples, key performance indicators, and how to distinguish between site-controlled retention issues and dropout due to drug-related factors (a critical distinction sponsors must recognize).

What You’re Not Charging For: From Identification to Justification

This session highlights where hidden costs are increasing and how they affect site budgets. After a quick refresher on tracking overhead, the focus shifts to newer pressures like political requirements, patient comfort costs, training expenses, academic pricing differences, and global cost variation. Learn how to justify these costs to sponsors, present them as value, and stay both sustainable and competitive.

AI Amplified: Advanced Implementation

This advanced session covers real-world AI implementation, sponsor restrictions, and build-versus-buy decisions. Learn how sites deploy AI for training generation, protocol setup, feasibility analysis, and workflow optimization while addressing sponsor AI restrictions and data privacy concerns. Discover when to build in-house versus leverage vendor tools, how to document compliant usage, and strategies for contractual limitations. Expect honest discussion about what’s working and what’s not.

Define Your Difference: Showcasing Your Site’s Unique Value

What truly makes your site memorable? Move beyond generic metrics to showcase what makes your organization unique: retention strategies, community ties, operational approaches. Hear from sponsors and CROs about what actually breaks through the noise, then refine your elevator pitch with narrative elements that make your site stand out.

Financial Strategies For Site Success

Build the financial foundation for long-term site success. This session covers business fundamentals that determine whether sites thrive or merely survive: contract structures that protect profitability, financial forecasting and essential KPIs, study-level profitability tracking, and cash flow strategies. Learn to implement systems that capture critical financial data, make informed decisions quickly, and prepare for the unexpected. Understand why financial strength differentiates your site and how larger sites now undergo financial due diligence as part of vendor risk management.

Leadership Roundtables (Site Managers, Executive Leaders, Business Development)

An exclusive roundtable where site leaders discuss operational challenges and co-create solutions. Leaders across different models (network, independent, academic medical centers) share real challenges in engaging specialists, operational excellence, staff expectations, project management, and leadership pressures. Learn how different site types approach similar problems and build meaningful connections with peers.

Record Retention Reality Check

This facilitated dialogue tackles a growing breaking point for research sites: record retention after regulatory obligations end. Most sites lack the infrastructure to support long-term storage, and electronic archiving has proven far more complex and costly than expected. Yet contractual pressure continues to rise. Bringing together site leaders, sponsors, and CROs, this session confronts why current practices are failing, examines what is driving retention demands, and works toward practical, shared solutions that reduce burden on sites while meeting regulatory needs.

Recruitment Revolution: Innovation & Recovery

Traditional recruitment processes aren’t keeping pace with enrollment demands. This session tackles two critical angles: deploying innovations that drive enrollment success and rapidly recovering when challenges emerge. Learn to recognize early warning signs within 30-60 days, master lead conversion, navigate budget advocacy, and implement collaborative problem-solving. Sites and recruitment specialists share stories with enrollment data, costs, and honest discussion about what’s working, what’s backfiring, and how to pivot quickly.

Reducing Site Training Burden: Results From Cut 25

The industry committed to reducing training burden by 25%. Now it’s time to see results. This session showcases documented outcomes from sites, sponsors, CROs, and vendors who successfully implemented SCRS’ Cut 25 principles. Through data-driven case studies, learn how organizations operationalized training reduction, the measurable impact on site operations, and specific solutions discovered through collaboration. Examine what’s working, brainstorm next-level improvements, and clarify each stakeholder’s role in sustaining outcomes and driving continued change.

Stack Smarter: Scaling Site Technology

Explore how a site’s technology ecosystem matures from early-stage operations to fully developed, multi-location networks. This session unpacks which tools sites adopt as they grow, how leaders decide between all-in-one platforms versus best-in-class modular approaches, and how to invest in tech that scales. Learn which technologies are essential versus enhanced at different growth stages, practical strategies for securing sponsor reimbursement, and how to operationalize tools you already have. Expect discussion on what truly scales, what doesn’t, and how to future-proof your tech stack.

Co-Creation Labs TBA

Co-Creation Labs Information To Come.