Launching a Clinical Trial Unit - Challenges, Solutions, and Early Impact

How Embedded Study Start-Up Expertise Helped an Academic Medical Center Build a Centralized Support Model for Clinical Trial Activation

Recognizing the Need for Centralized Clinical Trial Support

Attain Partners was hired to help a large, public research university improve its clinical trials department. Historically, support for non-cancer clinical trials within the client’s College of Medicine was distributed across individual investigators and departments with minimal support from central administrative offices. Investigators and study teams were responsible for navigating the many requirements involved in opening a clinical trial, including feasibility review, regulatory submission, contracting, coverage analysis, budget development and negotiation, and ancillary approvals. Although each participating office had an important role, there was no single resource responsible for coordinating the full study start-up lifecycle.

As a result, investigators and study teams often had to determine which offices to contact, understand different institutional requirements, monitor several parallel workstreams, and communicate status updates among sponsors and internal stakeholders. Processes and available support could vary by department, creating an administrative burden for research teams and limiting consistent visibility into the progress of studies moving toward activation.

To better understand these challenges, the College surveyed investigators and departments to identify their most pressing clinical research needs. The feedback highlighted the need for centralized expertise, clearer processes, and practical assistance with the coordination of non-cancer clinical trial start-up. In response, the College established a Clinical Trial Unit designed to support investigators, streamline administrative processes, and expand the institution’s capacity to conduct non-cancer clinical research.

To help move the CTU from concept to an operating resource, the client engaged Attain Partners to provide an embedded Study Start-Up Administrator. The administrator served as a centralized subject matter expert and liaison among investigators, study teams, sponsors, and internal offices. In addition to supporting active studies, the administrator worked closely with stakeholders to understand existing workflows, identify opportunities for improvement, and develop standardized SOPs, guidance documents, study trackers, activation checklists, and start-up process tools.

This combination of hands-on support and infrastructure development allowed the client to address immediate study needs while establishing a foundation for the CTU’s continued growth. Within its first year, the unit supported 33 clinical trials through 47 service engagements involving 23 principal investigators across 14 clinical departments, demonstrating early demand for and broad adoption of centralized study start-up support.

This case study highlights how Attain Partners helped a large, public research university establish and scale a centralized Clinical Trial Unit through embedded clinical research expertise.

Navigating a Decentralized Clinical Trial Start-Up Process

The College of Medicine lacked a dedicated, centralized resource to help investigators navigate the multiple offices, requirements, and handoffs involved in starting non-cancer clinical trials. Investigators and study teams were responsible for coordinating regulatory review, contracting, coverage analysis, budget development, hospital requirements, and ancillary approvals, often without a single point of contact overseeing the complete process.

Centralizing Clinical Trial Start-Up Support

Attain Partners provided an embedded Study Start-Up Administrator with broad operational experience across the clinical trial lifecycle. Serving as a centralized subject matter expert and liaison, the administrator worked with principal investigators, study teams, sponsors, and institutional offices to facilitate greater coordination and transparency throughout study start-up.

Attain Partners also provided budget development and negotiation support through the central research office, including the development of a standard institutional fee structure.

Additionally, Attain Partners worked with study teams and hospital stakeholders to create an early feasibility process. Study teams enter key information into REDCap, allowing hospital departments to review the study and approve it to move forward. This process helps identify and resolve logistical issues earlier in the study start-up process.

Attain Partners also helped translate institutional knowledge into standardized resources for the new Clinical Trial Unit, including SOPs, guidance documents, study trackers, activation checklists, and start-up process tools.

The engagement supported the development of a tiered service model ranging from advisory assistance and start-up support to potential future-state regulatory and study coordination services. This gave investigators clearer options for obtaining support while providing the College with a framework for expanding CTU capabilities over time.

Expanding Clinical Trial Capacity Through a Centralized Model

The combination of hands-on study support and infrastructure development allowed the College to address immediate investigator needs while establishing a foundation for the CTU’s continued growth.

Within its first year, the unit supported 33 clinical trials through 47 service engagements involving 23 principal investigators across 14 clinical departments. This early adoption demonstrated both the demand for centralized study start-up expertise and the CTU’s ability to serve investigators broadly across the College.

The engagement also helped establish more consistent processes for feasibility, study start-up, and budget negotiation. Standardizing budget negotiations supported stronger revenue recovery, while a centralized feasibility process helped assess whether studies were operationally viable earlier in the start-up lifecycle.

The College also established standardized tools, guidance, and processes that can support continued expansion of the CTU as investigator demand and clinical research activity grow.

Early Adoption Across the College of Medicine

Attain Partners – Clinical Trial Start-Up and Research Administration Experts

Attain Partners’ Study Start-Up Management, Budget Negotiation, and Business Process Redesign services help institutions build a more coordinated, efficient, and financially sustainable clinical trial start-up model. Our Study Start-Up Managers provide centralized oversight across the activation lifecycle, coordinating investigators, sponsors, and institutional offices to keep studies moving forward. Our Budget Negotiation services establish consistent pricing practices and help institutions recover the full cost of conducting research.

Through Business Process Redesign, we evaluate existing workflows, clarify roles and handoffs, and develop standardized processes, tools, and guidance that improve transparency, reduce administrative burden, and support long-term program growth.