Streamlining Clinical Trial Operations
An Academic Medical Center’s Path to Efficiency
Introduction
An esteemed academic medical center, with over 100 employees and more than 250 active clinical trials, was experiencing challenges in optimizing its clinical trial activation process. The center operates within a complex academic environment, comprising one hospital campus and multiple outpatient clinic locations, supported by over 100 clinical trial investigators. Despite efforts to centralize clinical trial operations, the organization faced significant delays, with project activation timelines exceeding 300 days for complex, industry-funded trials.
The primary objective of the consulting engagement was to streamline the organizational structure to enhance clarity regarding leadership roles, trial support responsibilities, and investigator involvement. Additionally, the engagement aimed to reduce the clinical trial activation timeline and improve communication with sponsors.
Challenge
Operating within an academic medical center environment presents distinct challenges related to process clarity and organizational structure. Despite implementing a centralized structure to improve efficiency and expertise, stakeholders still found it difficult to identify roles and responsibilities within the clinical research program. This lack of clarity led to inefficiencies and confusion about who was accountable for specific areas.
Furthermore, the center faced delays in clinical trial activation due to complex, multi-departmental processes involving legal, compliance, sponsored projects, grants, billing, and accounting. These lengthy approval paths led to activation timelines significantly exceeding industry benchmarks of 120 days.
Solution
To address these challenges, Stygma’s consulting team conducted a comprehensive assessment to map the roles and responsibilities within the clinical trial program. This evaluation clarified job structures, established reporting channels, and aligned divisional expertise effectively. The new organizational framework focused on technology, regulatory operations, clinical operations, and finance, forming a streamlined support matrix that encouraged interdisciplinary collaboration.
To tackle activation delays, the team audited each touchpoint within the trial activation process, identifying bottlenecks and recommending process improvements. These adjustments were implemented rapidly, leading to a more efficient and transparent activation pipeline.
Impact
The engagement led to significant, measurable improvements within the first fiscal year. The clinical trial unit became more streamlined, prioritizing clinical operations as the core of the program. Immediate reductions in activation timelines were observed, and long-term follow-up (spanning over three years) demonstrated a sustained 40% reduction in activation time, averaging 150 days for complex, industry-funded trials.
By addressing organizational structure and process inefficiencies, the medical center strengthened its capacity to conduct clinical trials efficiently, ultimately enhancing its ability to bring new treatments to the community it serves.