- Developing a translational and clinical research strategic plan for a four-hospital health system.
ECG assisted a large health
system in the development of a strategic plan for its clinical research enterprise. The plan primarily
focused on the development of bench-to-bedside research capabilities focused on cancer services and metabolic
disease. Strategies encompassed: (1) development of dedicated wet lab and clinical research space integrated
with clinical space for oncology, as well as clinical research space integrated with clinical space for
metabolic disease; (2) pursuing an innovative focus for translational and clinical research related to
cancer services (genomics and proteomics); (3) recruitment of research faculty for both areas of focus;
(4) establishment of significant partnerships with universities, public/private entities (TGen and others),
and industry to drive translational and clinical research activities; and (5) significant growth of research
for employed faculty balanced with research of private physicians occurring within Scottsdale Healthcare.
Our work resulted in a doubling of the research enterprise within 1 year.
- Conducting research facilities planning for a school of medicine.
We assisted a school of medicine in
assessing the need for expansion of its research facilities based on current activity, operational plans for
growth, and strategic initiatives. Over the course of this engagement, ECG analyzed and validated departmental
data related to research funding, investigator counts, research personnel staffing levels, and the allocation
of space. In addition, we interviewed department chairs and research center directors to acquire an
understanding of the adequacy of current facilities, as well as plans for additional research faculty and other
personnel. The project included benchmarking levels of funding and space allocation against those of peer
institutions and developing a model to aggregate data related to research funding, investigator counts, and
space allocation; incorporate anticipated growth plans; and determine IUSM’s future research facility needs.
The engagement resulted in a rationale for the expansion of research facilities in support of the school of
medicine’s strategic plan. Further, ECG demonstrated that current research facilities were fully utilized,
as well as documented the need for closer alignment of operational growth plans with strategic initiatives.
- Developing a research strategy and investment mechanism for a large AMC.
ECG assisted a large, university-based
AMC with development of a comprehensive strategy and investment mechanism for the research enterprise. Our
project resulted in the development of specific and focused strategies supported by an investment methodology
that fosters critical goals, including growth in the research enterprise, funding of key GWUMC initiatives,
interdisciplinary collaboration, focus on translational research, and appropriate administrative support of
research activities. Objectives of the engagement also included equitable investment among the school of
medicine, school of public health, teaching hospital, and faculty practice plan; enhanced accountability for
research productivity; and improved integration of research planning and funds flows with the educational and
clinical missions of the organization.
- Reviewing clinical trials management and assessing clinical trials billing for a major AMC.
In this engagement, ECG reviewed financial
management practices related to clinical trials for a major AMC. The review included an overview of processes
employed by various research administration functions, in addition to an in-depth examination of the professional
and technical fee billing related to clinical trials in four high-volume departments. Major tasks involved:
(1) account review to determine whether trial-related expenditures were appropriately charged to the sponsor and
whether residual balances were used in accordance with institutional policies and sponsor requirements; (2) analysis
of protocol details to determine whether trial-related services were billed inappropriately to third-party payors;
and (3) development of recommendations regarding the consolidation of clinical trials oversight within the
institution, as well as revised policies, procedures, and training programs. Subsequent to completing the
engagement, ECG continued its review of billing practices with an in-depth examination of professional fee billing
for selected clinical trials in two high-volume departments. Major tasks included analysis of protocol details
to determine to whom trial-related services should be billed; review of trial accounts to ensure that
non-standard-of-care services were charged appropriately; and detailed review of professional fee billing
documentation to ensure that third-party payors were not inappropriately billed for procedures related to clinical
trials.
- Assisting a medical school with a review of the Office of Scientific Affairs and interim management of the Office of Research Administration.
ECG assisted this medical school in
reviewing the organization and operations of its Office of Scientific Affairs. The project focused on the
research administration division and its role in compliance with federal and other sponsor regulations, including
human subject research protections. Major tasks involved: (1) interviewing several members of the research
enterprise to acquire an understanding of research administration roles and responsibilities within the medical
school; (2) reviewing policies related to the administration of sponsored programs for completeness and accuracy
relative to federal regulations; and (3) recommending organizational charts and position descriptions for
research administration staff. In addition, ECG provided interim management of the new Office of Research
Administration, created as a result of our Office of Scientific Affairs review. This project focused on the
implementation of our recommendations regarding the office’s organization and operations. Major tasks included
implementing a revised organizational structure; documenting processes and institutional best practices related
to clinical trial activity; designing and facilitating training programs for research administrators and
principal investigators; and facilitating continuing efforts to improve research compliance and the development
of policies and procedures related to sponsored research. ECG conducted two separate interim management
engagements within the Office of Research Administration.
- Reviewing research administration and infrastructure at a clinical trial-intensive teaching hospital.
ECG conducted a review of research
administration and infrastructure at this teaching hospital, in order to ensure that management processes provided
adequate controls. Major tasks involved: (1) assessment of practices related to the management of overall
research activities, including those activities carried out by affiliated institutions; (2) identification and
improvements to policies and procedures that would enhance management effectiveness; and (3) observation and
assessment of procedures employed in the management of clinical research, including activities of the IRB, patient
enrollment, and billing. The engagement resulted in recommendations regarding a revised organizational structure,
the addition of personnel responsible for compliance oversight, revised policies and procedures, revised billing
practices, and the development of a mechanism to effectively manage serious adverse events.
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