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Clinical Research Management and Data Coordinating Support

Office of Clinical Trials Operations and Management, NIDCR

OBJECTIVE

The purpose of this contract renewal requirement is to continue to provide comprehensive clinical research and clinical trials operations support, management and data coordinating services for NIDCR-sponsored clinical research and clinical trials.

The proposed contract will support clinical research studies funded by NIDCR in both the extramural and intramural research divisions. The contract will provide NIDCR with clinical research management support and oversight tools essential for the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution and monitoring, safety oversight, data management and analysis, and regulatory compliance.

BACKGROUND

As part of its overall research mission, the National Institute of Dental and Craniofacial Research (NIDCR) supports clinical research on the causes, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. These studies, conducted extramurally through the funding of research grants as well as within the intramural research program, include Phase I-III clinical trials as well as population-based and observational and natural history studies.

NIDCR’s extramural program has an extensive clinical research portfolio that covers a broad range of clinical efforts. Studies span small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical studies conducted both domestically and internationally. They include preventive, diagnostic and therapeutic interventional clinical trials as well as observational clinical studies. Intramural studies are generally performed in NIH’s Clinical Center and include both outpatient and inpatient studies, although some studies are multi-center and include clinical sites outside of the Clinical Center.

The current clinical research and operations management support (CROMS) contract has centralized a number of oversight and management activities such as study tracking, data and safety oversight and study monitoring. This approach has allowed some studies to be managed by program specific coordinating center. Management of other studies has been undertaken by the current CROMS contract in a tailored, study-specific approach. This management approach offers flexibility to meet the needs of different extramurally funded programs.

For clinical studies conducted in the intramural research program, unique, tailored arrangements are support each study. Coordination across these various entities as well as centralized operations support and oversight through clinical monitoring and safety oversight programs are managed by the current CROMS contract.

Currently, the CROMS contract provides protocol writing and development services to nearly 20 studies, clinical site monitoring services for approximately 40 studies, data management services for 11 studies and regulatory support to seven studies. Although NIDCR staff have expertise to assist with various aspects of study design and interpretation/evaluation of study results, these resources are finite. Through the retirement of a senior staff member, even fewer in-house resources are currently available to bolster the clinical coordination efforts needed to establish and maintain an efficient and high-quality clinical research program. Given the growing complexity and size of NIDCR’s clinical research program, including the extramural program’s focus on product development and biomarker studies, along with the growing number of intramural interventional clinical trials, there is a clear need for a centralized, standardized and cost-effective approach for NIDCR clinical research oversight and management.

In summary, this contract renewal requirement will provide operations and management support for the NIDCR clinical research program. This initiative will allow NIDCR to continue to consolidate much of the clinical research operations and management efforts and establish a more efficient and consistent approach to clinical trial and data management. In addition, the contract will support the use of tools, systems and services necessary for NIDCR staff to effectively manage its clinical portfolio. Activities supported by this contract may include:
1) consulting/collaborating on study design and protocol development; 2) study document preparation, including designing of case report forms, procedure manuals and other study materials; 3) study-specific training and/or study initiation site visits; 4) clinical research operations support (e.g. supply management, product packaging, labeling and shipping; clinical specimen tracking and storage); 5) data management; 6) assessing/assuring quality of study data; 7) study monitoring/auditing; 8) statistical data analysis; 9) safety monitoring; 10) regulatory support and FDA interface coordination; 11) preclinical product testing; 12) logistical support for Data Safety and Monitoring Boards; and 13) assistance with reporting and publication.


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This page last updated: February 26, 2014