Notable Discussions from SCOPE 2025: Aiming to Calculate, Accommodate, and Innovate for Enhanced Drug Development

Zahiah (Zee Zee) Gueddar, Senior Director, Commercialization, IQVIA Technologies

Melissa Mooney, Director Solution Engineering, IQVIA Patient Suite, IQVIA Technologies

Katie Shaw, Senior Director, Patient Recruitment and Enable, Global Patient and Site Services, IQVIA

For 16 years, the global SCOPE Summit has allowed research and development industry stakeholders to come together for transparent conversations about key ways to elevate patient-centered clinical trial innovation. With a record 4,500 attendees from 30 countries, the 2025 SCOPE Summit did not break from tradition, continuing efforts to collaborate and advance healthcare worldwide.

At SCOPE 2025, clinical R&D was covered from all angles, emphasizing why it is vital to drive innovation at every touchpoint to make a genuine impact in patient-centered drug development. There was no shortage of engaging panels, presentations and even one-on-one conversations during coffee breaks. Below we discuss several notable discussion topics that exemplify “calculate, accommodate, and innovate,” this year’s conference theme.

End-to-end clinical trial financial management from stakeholder perspectives

SCOPE 2025 was the ideal platform to dive deep into the intricacies of a trial’s financial management process and the need for orchestration and modernization, starting from benchmarking to contract ingestion through forecasting and managing payments. There is increasing market demand and pressure on sponsors to make efficient decisions to truly unburden sites and patients and help manage trial finances effectively.

Meeting demands of today’s R&D

As SCOPE attendees discovered, 50% of overall trial costs are related to investigator payments. And with the median cost of a single Phase III study at $48 million, it is critical to better address what’s required of key stakeholders with advanced tech-enabled approaches:

• The trial sponsor who needs its trial running on time and under budget.
• The site coordinator and staff who desire to be paid on time and efficiently as well as reduce the number of systems and technologies required to manage all their trials.
• The patient who wants to help the science move forward and avoid experiencing financial burden from participating.

Adding to these needs, financial complexities are only increasing.

Globalization challenges sponsors with conducting trials across an expanding set of countries and sites. The number of planned visits per trial has increased for participants, adding to the overall complexity.

Along with globalization of trials, the dense nature of precision medicine and evolving regulatory guidance are leading to trials experiencing more protocol amendments than in years past.

Recognizing these complexities, what do trial sponsors need to better orchestrate global clinical trial financial management from end-to-end?

Digitizing financial management

As trials become more digitized, financial processes are no exceptions. Trial sponsors demand innovations in financial solutions that can facilitate the management of complex protocols, enable site success and ultimately, accelerate getting life-changing products to market.

Extensive clinical trial experience and SaaS- and tech-enabled payments solutions that are intuitively designed to answer the following questions may help optimize seamless trial financial management throughout the trial life cycle while creating cost savings for sponsors:

• Budget planning: Is there a comprehensive market database of global investigator grant benchmarks so budgeting teams can accurately forecast grants and effectively negotiate?
• Contract negotiations: Is it possible to write, exchange and amend contracts between sites and sponsors in a systematic way?
• Forecasting: Is there an effective approach to manage and predict site payments to maintain accuracy, compliance and efficiency across complex, global trials?
• Clinical trial payments: Can one platform help better manage trial payments to sites, ensuring smooth workflow, transactions, global payment disbursement and reporting?
• Patient payments: How can we ensure compensation to trial participants across the globe with transparency and ease?

As part of a smarter payments platform, integrating point solutions and automating processes via artificial intelligence is helping to ingest complex documentation, provide quality checks and analysis, extract key details and populate payment systems to help reduce error-prone manual data entry, avoid delayed and inaccurate reimbursements and enable site success.

Promoting representation in clinical research: Actionable strategies in play

To ensure all patient voices are heard in clinical research, attendees at SCOPE had the opportunity to learn from leaders within mid-to-large pharmaceutical companies, a site network organization and CROs that focus on further breaking down barriers in clinical research in their daily roles. In this meaningful discussion, these experts shared their key takeaways for enhanced clinical trial design and operational planning.

According to the expert panel, promising ways R&D stakeholders can help accelerate progress include:

• Putting aside competitive mindsets: Addressing representation in trials is a collaborative effort in which sharing insights are beneficial to all. Panelists said SCOPE and other industry gatherings are important for initiating dialogue. The group also praised nonprofit healthcare associations that aim to connect voices in clinical R&D to improve drug development and ensure trials are more accessible for all patient populations.
• Elevating transparency and open feedback between sponsors, sites, and patients: Understanding the nuanced challenges that disproportionately impact underrepresented populations can guide sponsors and CROs toward pragmatic solutions. This includes addressing logistical roadblocks, including transportation, child care, frequency of site visits, or travel time to site visits. For example, panelists noted that empathy for people’s experiences and issues can strengthen relationships and build trust, creating opportunities to meet recruitment goals for infectious disease-related vaccine studies with aggressive timelines.
• Advocating for sites and tightening community partnerships: Trial sites are the pioneers of patient-centric practices. These team are members of the communities they serve and are seen as partners at the local community level that sponsors and CROs cannot be. Panelists encouraged sponsors and CROs to build stronger relationships with investigators and site staff from varying backgrounds who can help reach a broad array of patient populations. Sites can also help create local awareness about trials through community events (e.g., hosting or participating in health screenings) and by networking with community leaders.

Driving endpoint protection: The value of using eCOA

As the healthcare landscape becomes patient-centric, clinical outcomes assessments are helping sponsors, regulators, payers, providers, and others ensure each patient can share their story. With electronic clinical outcome assessments (eCOAs) playing a prominent role in supporting endpoint strategies, it is vital that eCOA data is accessible and represented in a meaningful way for all stakeholders reviewing, from site staff to the sponsor, study team, data managers, and biostatisticians.

SCOPE attendees heard from expert eCOA solution engineers who said eCOA technology solutions need to be designed “smart” to drive endpoint protection in terms of:

• Upholding protocol compliance and data quality and integrity.
• Ensuring appropriate oversight of eCOA data to inform clinical decision-making and identification of potential risks to study endpoints.

Customizing eCOA monitoring

Designing eCOA data dashboards to provide various stakeholders options for how they see data can help with the objectives above. For example, when providing:

• Response reports, standard response listings may offer a view of standard raw response data, including screenshots and notes; be capable of exporting reports in Excel/CSV format; and be available for sites and clinicians to see during the study. Customized reports offer the standard capabilities but can also offer specific formatted views of response data, allow users to choose specific fields, and apply color coding for easier reporting purposes and set up for delivery to users on a regular basis.
• Dashboard reports, standard dashboards are pre-built for sponsors and sites and include compliance metrics and interactive features. Going further, it is possible to design with protocol-specific needs in mind, including creating custom dashboards on demand. If needed, options such as visual representations of aggregated response data, data filtering, and custom eligibility reports are possible.

Automating eCOA data compliance monitoring

Customized views of data are a critical piece of the puzzle. Another piece is ensuring an automated data flow is in place to reach all relevant stakeholders when it is their “turn” to act, whether it is to prevent, monitor or intervene when issues with data, such as noncompliance, arise. (See Figure 1 below.)

Figure 1.

Source: IQVIA

As part of a comprehensive IT infrastructure, study teams and sites can have a watchful eye on eCOA endpoint data to reduce the risk of medically improbable data and/or noncompliance and improve endpoint data quality. eCOA monitoring dashboards that are designed to monitor for an allotted number of protocol-specific rules critical to endpoint success (e.g., missing data, inconsistent status or event dates used across systems, medically improbably symptoms, etc.) can help ensure potential problems are identified for earlier intervention.

Other critical pieces to improving eCOA data quality include:

• Integrating eCOA experts into trial planning helps align protocol requirements with the site and patient experience to capture higher-quality data.
• Having patients learn from training videos/literature to motivate compliance and accurate reporting of symptoms, etc.
• Having site staff complete learning modules that align with patient training materials to reduce bias.

Continuing discussions and progress

At SCOPE 2025, we once again came together to connect with fellow stakeholders and experts who share a common passion to positively impact patients’ lives.

Sharing our expertise and taking in insights to drive clinical trial innovation was both rewarding and inspiring. As we continue to build on our collective knowledge and experience to make a genuine impact in global healthcare, we look forward to reconvening at next year’s meeting, ready to discuss the latest in R&D.

Zahiah (Zee Zee) Gueddar, Senior Director, Commercialization, IQVIA Technologies; Melissa Mooney, Director Solution Engineering, IQVIA Patient Suite, IQVIA Technologies; and Katie Shaw, Senior Director, Patient Recruitment and Enable, Global Patient and Site Services, IQVIA