One Clinical: Working Together to Advance Trial Collaboration

Clinical trial innovation is advancing, but the way the industry plans and executes studies has evolved far more slowly. Trial designs are increasingly complex, regulatory expectations continue to rise, and research sites face growing operational demand. Yet, many trials are conducted through fragmented systems, sequential handoffs, and study- or sponsor-specific processes that hinder collaboration and create inconsistent execution.

As a result, trial performance and site engagement, two outcomes that are deeply connected, are often treated as separate priorities. Sponsors focus on timelines and oversight while sites work to manage increasing operational burdens. When these perspectives are not aligned early, inefficiencies emerge that slow studies and strain the sites which are critical to clinical research. In Veeva’s work with sponsors, CROs, and sites, these challenges appear consistently across organizations.

The concept of One Clinical reflects a shift in how the industry approaches trial collaboration. Rather than viewing stakeholders as participants in a sequence of handoffs, it encourages a model for working with greater consistency, shared visibility, and earlier engagement throughout the clinical lifecycle.

At its core, this shift recognizes that stronger collaboration requires more than improved communication. It calls for structural changes in how trials are planned, decisions are made, and information is shared. When sites are engaged earlier, feasibility decisions incorporate operational insight, and stakeholders work with a shared view of study progress. These changes will drive trials that are more predictable and sustainable.

Clinical trial technology plays an important role in this evolution. A more connected foundation can reduce complexity by allowing seamless flow of data, documents, and processes across systems and functions.

Together, these shifts create a different operating model for clinical research. A model that emphasizes earlier collaboration, shared insight, and sustained dialogue across sponsors, CROs, and sites. The goal is not only greater efficiency, but a more collaborative and resilient clinical ecosystem capable of supporting the next generation of trials.

Why change is necessary

Clinical research is at a pivotal moment. Scientific and therapeutic innovation continues to advance, while regulatory expectations, including those outlined in ICH E6(R3), reinforce the need for stronger sponsor oversight and more risk-based approaches to trial management.

At the same time, trial execution often relies on study-specific processes and siloed systems that introduce unnecessary complexity. These conditions create inefficiencies for sponsors and trial-by-trial ways of working for research sites.

More than 70% of sites report that managing multiple system logins, navigating sponsor selected vendor portals, and completing redundant or irrelevant training are among their most significant challenges. These demands divert time away from patient care and trial execution.

Investigators consistently express a desire to collaborate more effectively with sponsors. The barriers are rarely a lack of willingness to engage, but the outcome of a disconnected clinical ecosystem that was not designed to scale with the industry's rate of innovation.

Site training illustrates this challenge. Training requests from sponsors are often repetitive and not assigned by individual roles. Without cross-industry collaboration and the right tools to scale, solutions typically end up as one-off approaches. Role-specific, interactive training completed once and accepted across studies and sponsors could significantly streamline staff onboarding and upskilling.

Addressing these challenges will require more than incremental process improvements. Meaningful progress depends on structural alignment in how sponsors, CROs, and sites plan and execute studies together.

Designing trials for seamless, connected execution

Many of the structural challenges facing clinical research converge at the site level. Addressing them requires rethinking how trials are designed and executed across several key areas.

1. Earlier collaboration as standard practice

In many trials, site involvement begins after key decisions have already been made. Protocols are drafted, assumptions are set, and feasibility is assessed downstream. When the study encounters operational realities, the rework required adds effort for sites and risk for sponsors.

Creating structured opportunities for sites to contribute insight during protocol development and feasibility planning helps to close this gap. When site input is incorporated early and investigators can see how their input informs study design, protocols become more realistic, patient identification improves, and execution becomes more predictable with fewer amendments.

Closer collaboration with sites does not slow decision-making. In many cases, it improves it by grounding plans in practical experience and reducing avoidable friction during study start-up and execution.

2. Two-sided decision-making

Traditional trial planning often follows a one-directional model: sponsors request information, sites respond, and decisions are made centrally with limited visibility into site realities. This dynamic can create misalignment between study requirements and site capacity, leading to variability in study performance.

A more collaborative approach treats site selection and feasibility as shared decisions. Sponsors and sites evaluate readiness together, aligning expectations with operational constraints before a trial begins. This improves transparency around capacity and resources, enables earlier identification of strong site partners, and highlights where additional preparation or support may be needed.

Collaborative decision making strengthens outcomes by grounding planning in a more complete understanding of successful execution requirements.

3. Shared visibility

Trial execution becomes more difficult when information is fragmented across systems and stakeholders. Without a consistent, shared view of enrollment queries, issues, and standard performance metrics, sponsors and sites often operate with different understandings of study status. This can lead to redundant requests and delayed responses.

When stakeholders work from a consistent view of study information, coordination improves and potential challenges can be identified and addressed quicker. Sponsors gain clearer insight into where support is needed while sites spend less time responding to overlapping requests. Increased transparency reduces uncertainty and builds trust throughout a study.

4. Continuous dialogue across the trial lifecycle

Sponsor-site collaboration typically peaks during feasibility and start-up, then becomes more reactive once a study is underway. Communication shifts toward issue resolution rather than proactive alignment.

Maintaining structured, consistent dialogue throughout the study lifecycle helps teams stay aligned as requirements change. Sites express wanting to work closer with sponsors, as many believe standardized communication and governance can strengthen collaboration. A practical example is assigning sponsor contacts within the site’s time zone, enabling faster feedback and more effective coordination.

5.Technology as a foundation for collaboration and visibility

A more collaborative trial operating model requires modern, connected technology. Today, sites must navigate numerous systems and portals, often relying on manual trackers or spreadsheets to manage study activities.

These inefficiencies extend to other trial processes, including monitoring. Many clinical research associates (CRAs) report that reconciling information across multiple systems and manual site trackers is one of the most time-consuming aspects of monitoring visits.

A connected technology foundation allows data, documents, and workflows to move seamlessly across stakeholders. As information flows more consistently, duplication decreases and processes become easier to manage. The goal is not simply to introduce new applications, but to enable standardized ways of working across the clinical ecosystem.

A new model for collaboration in clinical research

The challenges facing clinical research today are not isolated or temporary. They reflect the natural evolution of an ecosystem that has become more complex, specialized, and interdependent without fully evolving its collaborative model.

Addressing these challenges requires rethinking how decisions are made, how early insights are incorporated, and how sponsors, CROs, and research sites work together across the clinical lifecycle. Faster, higher-quality trials depend on continuous stakeholder communication, shared visibility, and consistent ways of working supported by modern technology platforms.

No single organization can drive this evolution alone. Progress depends on collective engagement across the clinical research community. As an industry, creating neutral forums to openly discuss shared challenges and explore new models of collaboration will be an important part to adapt and refine trial operations.

These discussions also create opportunities to reassess processes that add limited value. For example, as data is increasingly captured directly at the site and shared in real-time using eSource, traditional approaches, such as extensive source data verification (SDV), can evolve to more targeted, risk-based methods that maintain quality while reducing operational burden.

One Clinical is an invitation to engage with stakeholders, challenge existing assumptions, and help define the future of drug development. The next generation of trials will be shaped not only by scientific innovation, but by how effectively the industry collaborates and how well it supports the sites that make clinical research possible.

About the author

Jim Reilly, president, Veeva Development Cloud, has over 20 years of experience in life sciences industry software, strategy, and consulting. Today, Jim leads the strategy, execution, and growth of Veeva Development Cloud and is a Board Member for The Association of Clinical Research Organizations (ACRO).