Transforming Clinical Trial Administration:

A Health System Case Study

Introduction

A California health system, encompassing over 50 employees, five hospital campuses, and multiple outpatient clinic locations, faced challenges in centralizing its clinical trial program. With more than 300 active clinical trials and over 100 clinical trial investigators, the system experienced a lengthy timeline to project activation—often exceeding 250 days for complex, industry-funded trials.

The health system sought to unify its Oncology and Non-Oncology trial portfolios under a streamlined administrative structure. The goal was to enhance clinical trial audit readiness, financial solvency through efficient revenue management, and overall program efficiency through improved pre- and post-award processes.

Challenge

After forty years of conducting multi-specialty clinical trials funded by industry, government, and philanthropic sources, the program had become fragmented and difficult to manage. Referred to as a “black box” by leadership, the program’s cost to the institution had outpaced the return on investment in patient care and scientific advancements.

The decentralized administrative structure led to inconsistencies in trial conduct, prolonged approval timelines, patient enrollment delays, and challenges in data entry and revenue collection. Employees lacked clarity on navigating the approval process, engaging clinical staff, and communicating with Sponsors and funding partners. A comprehensive audit revealed that these issues were pervasive and required a transformative approach.

Solution

A thorough program evaluation led to the development of a multi-phase treatment plan:

Phase 1:
Stabilization

  • Transitioned to a unified administrative structure to scale responsibilities and eliminate redundant processes.

  • Addressed backlog by reviewing over 120 trials, resulting in expedited actions or closures.

  • Cleared over $7 million in delayed research claims and introduced new technology for transparent reporting.

Phase 2:
Optimization

  • Hired key personnel with expertise in managing large clinical trial programs.

  • Standardized governance to ensure uniformity across geographically dispersed sites.

  • Implemented comprehensive training to support consistent, measurable research outcomes.

Phase 3:
Growth & Market Differentiation

  • Pursued program accreditation to enhance program credibility.

  • Implemented an electronic IRB system and a grant management platform to support regulatory compliance.

  • Established industry partnerships and improved Sponsor engagement through a structured relationship-building initiative.

Impact

Within a year, employee satisfaction rose from the bottom quartile to the top 10% of the system-wide survey. Investigator satisfaction and Sponsor engagement increased significantly, with Site Qualification Visits converting to Site Initiation Visits 50% more frequently. Financial dependency on health system subsidies dropped by 20% annually, while revenue rose in line with trial pipeline growth. Activation timelines for complex trials were reduced by over 50%, with observational trials activated in under 30 days.

The program’s resilience was tested during the COVID-19 pandemic when the health system became one of the first five sites in the US to initiate a treatment trial. The trial was activated within one week, showcasing the program's preparedness and agility in addressing emergent public health needs.

This successful transformation demonstrates the value of targeted, phased intervention in revitalizing clinical trial administration, ultimately benefiting patient care and advancing scientific discovery.