Baga, Leslie, RN, MSCRA, CCRC

Mueller, Eric, MSA, MBA

English

Lehigh Valley Health Network: LVHN Scholarly Works

Lehigh Valley Health NetworkLVHN Scholarly WorksPatient Care Services / NursingFrom Silos to Centralization: A Seven YearExperienceLeslie Baga RN, MSCRA, CCRCLehigh Valley Health Network, Leslie.Baga@lvhn.orgEric Mueller MSA, MBALehigh Valley Health Network, Eric_M.Mueller@lvhn.orgFollow this and additional works at: https://scholarlyworks.lvhn.org/patient-care-services-nursingThis Poster is brought to you for free and open access by LVHN Scholarly Works. It has been accepted for inclusion in LVHN Scholarly Works by anauthorized administrator. For more information, please contact LibraryServices@lvhn.org.Published In/Presented AtBaga, L. Mueller, E. (2018, September 27). From Silos to Centralization: A Seven Year Experience. Poster Presented at: Society of ClinicalResearch Associates, New Orleans, LA.LVHN.org© 2018 Lehigh Valley Health NetworkFrom Silos to Centralization: A Seven Year ExperienceLeslie Baga, RN, MSCRA, CCRC Eric Mueller, MSA, MBALehigh Valley Health Network, Allentown, Pa.BACKGROUNDTraditionally, frameworks upon which clinical site research pro­grams have been built have  consisted of decentralized silos working independently with a  similar focus. Trends in health care and increased regulatory oversight have resulted in the emersion of “centralized” research models. There are varying levels of cen­tralization, ranging from efforts to  centralize single entities (e.g.,  business office activities, grant  processes, staff resources) to com­plete centralization of all research activities across a site. At any level, the path to centralization requires forethought and a unified team possessing attributes of resiliency, innovative thinking and excellent interpersonal skills.CONCLUSIONSetting the stage for a truly cen­tralized research model at a clinical site requires commitment from the highest levels of an institution. Even with this support, many  challenges persist, e.g., issues  with staffing, facilities, electronic systems, training, budget and  contract negotiations; maintaining good customer service; and pro­moting a positive workplace.  Although these challenges may be onerous at times, they can be over­come by having a vision of future directions and a strong team to transform the vision into reality. A centralized model can be a lasting investment in quality and, ultimately, financially and administratively  lucrative for a clinical site.METHODSSeven years after the initiation of a centralized model, a clinical site evaluates its process and progressYear one – the most challenging of all. Bringing individual silos together requires strong leadership, persistence and adaptability. Key points during this first year include evaluating existing independent departments, hiring staff, making financial determinations regarding historical funds, choosing the leaders, naming the department, and establishing operational processes. Year two – the dust has settled; now what? Key points during the second year include administering a needs assessment to researchers, developing staff, creating standard operating procedures for research, establishing research review committees, building a centralized business office, re­establishing industry contacts, and providing resources for investigator­initiated studies. Year three – the ground is becoming solid. Begin setting the stage for new opportunities to grow and further develop the program. Key  points include evaluating and refining processes; retention of high­performing staff; assuring  compliance through continued education and partnering with compliance services; under­standing the site’s portfolio of research and  setting future trends and goals; partnering with sponsors; and expanding services. Year four – busier than ever; what happened? Year four is the time when sponsors are recognizing the site as a desirable, high­functioning site. Key activities during year four include triaging trials to staff in an era of lean management, complex trials, and increased training requirements; assuring compliance while accepting more projects; continuing development and education for staff and new investigators; and determining where strengths and challenges lie within the various clinical specialties. Year five and beyond – a more sophisticated model. The centralized office is recognized by all within the network. Expansion of research is being initiated at satellite sites and partnerships within the oncology research arena are being developed and fostered. Most important, the foundation  of quality and education serves as a pillar, continuously supporting the research infrastructure.

From Silos to Centralization: A Seven Year Experience

https://scholarlyworks.lvhn.org/cgi/viewcontent.cgi?article=1999&context=patient-care-services-nursing

From Silos to Centralization: A Seven Year Experience

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Lehigh Valley Health Network: LVHN Scholarly Works