Centralized Clinical Trials Offices and Research Institutes

Client Situation 1

A pediatric hospital had formed a joint venture with a nearby medical school to create a stand-alone research institute. As the building was being constructed, McAllister Consulting was called upon to conduct a comprehensive operations review / compliance risk assessment of the entities’ research operations in order to provide recommendations on management infrastructure and future roles / responsibilities of the research institute and its respective owners.

Core Competency: Regulatory, Research Operations, & Strategic Plan Development

Consulting Objectives:

• Identify functions / operational areas of the hospital and medical school that should be centralized in order to provide maximum efficiencies and competitive advantage.
• Determine the optimum management structure from both a regulatory compliance perspective as well as an operational perspective based on senior management’s risk comfort level

Approach:

• Bridge the information and communication gaps between the hospital and medical school.
• Identify strengths / weaknesses and “best practices” in the owners’ current research operations.
• Eliminate redundancies by centralizing certain functions / operational areas in the research institute or assigning the function to the owner with the greatest experience and expertise.
• Recommend an appropriate management structure within the research institute for day-to-day operations and compliance activities.

Outcomes:

• Active clinical studies and extramural funding increased by 29% in first three years of operation.
• Robust compliance program focused on research activities that complement the owners’ corporate compliance programs.

Client Situation 2

One of the nation’s premier research universities was looking to become recognized worldwide as the nation’s leading research university in the next ten years. However, as with any traditionally-structured academic institution, the level of research conducted was driven by and directly dependent on the productivity of its faculty. Thus, a centralized office was created to facilitate the development and implementation of clinical research by providing assistance to researchers, provider-partners, and sponsors. McAllister Consulting was asked to recommend the infrastructure best suited to the university.

Core Competency: Regulatory, Research Operations, & Strategic Plan Development

Consulting Objectives:

• Determine “customer” needs in order to define the scope and responsibilities of the centralized office.
• Identify any overlaps of proposed responsibilities with other administrative support offices.
• Determine the optimum infrastructure based on current and projected volumes and identify current and future space and staffing needs.
• Improve profitability from industry-sponsored research activities and enhance compliance.

Approach:

• Using our proprietary life-cycle approach, conduct an operations review / risk assessment of colleges and academic units, as well as administrative support services, in order to process map current workflow.
• Facilitate focused work group discussions with researchers and administration to determine customer needs.
• Identify strengths / weaknesses and “best practices.”
• Eliminate redundancies and / or develop processes and procedures to address unmet needs.

Outcomes:

• Process mapped “as is” and “to be” workflows.
• Organization chart, including space and staffing needs for the new centralized office.
• Mission statement, strategic goals and objectives for the new centralized office, aligned with those of the university.
• 2-year strategic plan for meeting strategic goals and objectives.

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