SCCR’s Coordinating Center (CC) provides a full array of clinical research capabilities essential for trials supported by industry, foundations and government sponsors. The Coordinating Center provides capabilities required for successful execution of single or multi-site studies with operational efficiencies and cost savings.
Our Core Capabilities
Our project management capabilities encompass all aspects of clinical research and clinical trial management. The project management team has a proven track record of success in clinical research management in both industry and academia and has diverse backgrounds in areas such as medicine, biology, biotechnology, public health, pharmaceutical and medical device innovation. The project management team partners with the Principal Investigator and Sponsor to facilitate the meeting of all clinical research milestones from study start up to close out.
The project management team coordinates the expertise of cross-functional teams to provide capabilities in:
- FDA and IRB (institutional review board) submissions
- Documentation production (informed consent forms, case report forms, investigational brochure, study procedures manuals, etc.)
- Definition and management of study budgets
- Resource management
- Input on study protocol and database development
Clinical event adjudication
SCCR Clinical Event Committee (CEC) group provides comprehensive endpoint adjudication evaluation as established in the standards of research classification. The CEC applies a systematic approach to evaluate clinical events that will validate the increasing emphasis of regulatory oversight in advancing the quality of clinical research.
The CEC consists of highly qualified and certified healthcare professionals with expert knowledge of the clinical adjudication process. Event reviewers have a range of specialties such as neurology, cardiology, nephrology, and radiology. This team is driven to conduct world-class clinical research operations with an extensive network of collaborators within and outside the United States.
SCCR CEC provides the following capabilities:
- Development of CEC charter
- Endpoint CRF (case report form) design
- Endpoint definitions
- Develop and execute CEC quality control plans at various key points of the study
- CEC member training and meeting coordination
The SCCR partners with the Quantitative Sciences Unit (QSU) to provide statistical support to the Data Safety Monitoring Board (DSMB) for ongoing clinical trials of all phases. The QSU is a collaborative statistics unit within the Biomedical Informatics Research (BMIR) Division in the Department of Medicine (DOM). The SCCR and QSU teams partner to manage and provide operational support for DSMB activities.
The SCCR in collaboration with the QSU provides following DSMB capabilities:
- Identification of qualified DSMB committee members
- Contract Negotiation
- Management of information flow between the DSMB, study team members and sponsor.
- Development and/or review of DSMB Charter
- Management of DSMB meetings:
- --Scheduling and other logistical support
- --Agenda and Meeting Minutes
- Generation of relevant tables and figures to describe interim efficacy and safety
- Archiving of Data Packages, Meeting Minutes, Evaluation Forms, and other documents
Data management & Statistical capabilities
The SCCR partners with the Quantitative Sciences Unit (QSU) for its biostatistics and informatics needs including data management, study design, and data analysis.
Study Design. QSU members have expertise in designing both observational and experimental trials across all phases. We work with the QSU to arrive at optimal study designs for the studies that we coordinate.
Data Analysis. QSU members work with SCCR and investigators to design scientifically sound analysis plans. QSU members have strong expertise in how to handle missing data, the modeling of correlated and clustered data, and the analysis of right-censored data, among others. QSU members work closely with the research team to implement analyses in a timely manner and to provide guidance on interpretation of findings.
Data Management. QSU members have expertise in the creation of databases and development of software to implement tools for carrying out analyses. The QSU works with SCCR and research investigators to design secure IRB-compliant databases that are tailored for studies in which we are involved. To that end, we provide:
- Draft Data Management plan
- Database design
- Database programming
- Data edit specifications and edit reports