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. They also possess experience in a multitude of study areas such as medicine, biology, biotechnology, public health, and 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 with cross-functional teams to provide capabilities in:
- FDA and IRB (Institutional Review Board) submissions
- Study-related documentation production
- 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 by the standards of research classification. The CEC applies a systematic approach to assess 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 analysts have a range of specialties including neurology, cardiology, nephrology, and radiology. Our team strives 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
- Establish endpoint definitions
- Develop and execute CEC quality control plans throughout a study
- CEC member training
- Regular CEC meeting coordination
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 unite to manage and provide operational support for DSMB activities.
SCCR in collaboration with the QSU provides the following DSMB capabilities:
- Identification of qualified DSMB committee members
- Contract Negotiation
- Management of information between the DSMB, study team members, and the sponsor.
- Development and review of DSMB Charter
- Management of DSMB meetings
- Generation of relevant tables and figures to define interim efficacy and safety
- Archiving study-related documents and data
Data management & Statistical Capabilities
SCCR partners with the Quantitative Sciences Unit (QSU) for its biostatistics and informatics needs like data management, study design, and data analysis.
Study Design. QSU members are skilled in designing observational and experimental trials across all phases. We work with the QSU to achieve optimal study designs for the research that we coordinate.
Data Analysis. The QSU works with SCCR to design scientifically sound analysis plans. Having experience in handling missing data, modeling correlated or clustered data, and analysis of right-censored data, QSU members work closely with the research team to conduct analyses and provide guidance on the interpretation of findings.
Data Management. The QSU is valuable in the creation of databases and software necessary for conducting analyses. The QSU works with SCCR research investigators to develop 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 and programming
- Data edit specifications and edit reports