Support for Large Grants
Planning, developing and running a multicenter clinical trial is a daunting task that often involves hundreds of steps, years of planning, and spiraling costs. For researchers, the logistical burden can be overwhelming. To assist in this process, NYU Grossman School of Medicine’s Center for Large Scale Clinical Studies offers investigators guidance and support to conduct a large multicenter trial.
Center for Large Scale Clinical Studies
Our Center for Large Scale Clinical Studies provides centralized support to investigators who are developing large grant applications for multisite clinical studies as well as those who have received funding and need support for implementing their studies. Our team of clinical trial specialists has expertise in study design and all aspects of clinical research operations, and can assist investigators from early study planning all the way through the study startup and implementation phase.
In addition to requiring clinical sites, large multicenter trials also require coordinating centers, most often a Clinical Coordinating Center (CCC) and a Statistical and Data Coordinating Center (SDCC). NYU Grossman School of Medicine can act as these coordinating centers for large scale clinical studies.
As a CCC, we hold the primary responsibility for developing the study protocol; recruiting and managing clinical sites, including site activation and personnel training; communicating with regulatory agencies; and overseeing the conduct of the clinical trial, including site monitoring.
As a SDCC, we play a key role in trial design and analysis, and are responsible for data oversight and monitoring, data collection, data integrity, generating reports, and training. Our personnel within the CCC and SDCC are experienced and highly competent in the coordination of complex clinical trials.
Additional support for large grants is also provided by DataCore, which provides researchers with services such as electronic data capture and storage, database design, and data management and analysis.
During the preaward phase, our grant development services vary based on the needs of the study team. Our team has the expertise to assist investigators in different areas, which may include the following:
- study design
- assisting in drafting or providing templates for grant-related documents such as the research plan, study protocol, and manual of procedures
- editing and revision of grant-related documents
- budget development and review
- overseeing all institutional and federal regulatory submissions required for the conduct of the clinical trial
- liaising with research offices within the institution
- offering researchers a suite of information technology tools and services to collect, store, track, and analyze vast collections of data, and collaboration with DataCore and our biostatistics experts, who play critical role in the SDCC
- assembling administrative components and coordinating the entire grant submission
After a grant is awarded, the study startup process is critical to the overall success of the research project. Our experts are available to assist study teams in the initiation of large multi-center trials that have already received funding. Services may include the following:
- assisting in drafting or reviewing study documents including the study protocol, manual of procedures, and standard operating procedures
- assisting in the hiring of qualified study personnel
- liaising with institutional research offices and external vendors
- coordinating the startup of the clinical sites including the establishment of the CCC and SDCC, if applicable
- training study staff
Please contact Jacqueline Arciniega, MPH, administrative director, at firstname.lastname@example.org for assistance with complex proposal development and implementation.