SC CTSI Biostatistics and Bioinformatics Resources -- Our Biostatistics and Bioinformatics Resources offer individualized support across the lifecycle of clinical and translational research studies. Services include advice and assistance with developing study protocols, experimental designs, and analytical strategies; preparing data analysis plans, including interim efficacy and safety monitoring; creating and reviewing data acquisition plans, including collection and coding; responding to reviewer comments; training on study design, and data collection and data analysis.
SC CTSI Education, Career Development, and Ethics -- Our Education and Career Development program offers four main services for clinical and translational science. In-depth training and career development is available for selected pre-doctoral trainees and early career clinical researchers through NIH-supported programs. Access to certificate and Master of Science programs, assistance with locating mentors and improving mentoring skills are available for a wider audience throughout USC and its SC CTSI partners. Educational programs drawing on expertise of USC faculty members and SC CTSI partners are available for medical students, fellows, faculty, staff, community providers and others.
Translational research can raise unique ethics questions, and understanding those concerns is crucial for safe and successful conduct of translational projects. That is why our Research Ethics program provides not only education and training, but also research ethics consultations to help researchers and clinicians anticipate, identify and respond to relevant ethical issues; adopt and share best practices; and harmonize review practices.
SC CTSI Clinical Translation / Clinical Trials Unit -- Our Human Studies program is dedicated to promoting the translation of basic discoveries to the patient bedside by providing the appropriate clinical research infrastructure and assisting investigators in the development and conduct of their studies. As a central part of its mission, we have established two Clinical Trials Units (CTUs)--one at the Keck Hospital of USC and one at Children’s Hospital Los Angeles.
The CTUs offer a unique resource that is ideal for the conduct of clinical trials and mechanistic studies aimed at unraveling complex physiologic processes. The CTUs provide a well-equipped physical space, well-trained and dedicated clinical research staff, and a laboratory for specimen handling and processing. Such infrastructure is essential for drug development studies that require serial blood draws for pharmacokinetic and pharmacodynamic assessments and for mechanistic studies that may require a multidisciplinary approach and multiple evaluations of physiologic and hormonal changes. Intensive monitoring for patient safety can be provided as required by the specific clinical trial. The CTUs are dedicated to providing excellence in clinical research conduct, compliance with all relevant regulations, and the highest degree of patient safety.
SC CTSI Preclinical Translation and Regulatory Support -- Our Pre-clinical Development program offers defined management processes to help researchers conceptualize, explore, and commercialize novel approaches to treatment and diagnosis of human disease. Investigators receive expert guidance, access to pre-clinical translational resources, mentorship, protocol and project development assistance, and other vital services to take basic discoveries through the complicated pre-clinical development process. Services are provided through close partnerships with the USC Stevens Institute for Innovation, which focuses on intellectual property management and commercialization, and with the Technology Transfer Office at Children’s Hospital Los Angeles.
Our Regulatory Support program offers knowledge, training, and services to help researchers navigate the complex regulatory environment that governs clinical and translational research. Services include guidance on Investigational New Drug/Investigational Device Exemption (IND/IDE) regulations; creating FDA-compliant research plans for every stage of maturity; integrating regulatory and other SC CTSI advice; understanding regulatory processes that reduce or remove barriers; and participating in an SC CTSI Continuous Quality Improvement initiative.
SC CTSI Community Engagement -- Community engagement bridges researchers and local communities, building sustained partnerships that ensure research initiatives meet real community needs. Researchers benefit by focusing on timely, responsive, culturally relevant targets, while community members can directly influence research choices and academia-community relations. Through the Community Engagement program, researchers learn to engage community members in scientific work, and community members learn to nurture research ideas. Services include training and technical assistance workshops for community-engaged research; individual consultations for USC faculty, partners and community members; and matchmaking between those constituencies.
SC CTSI Research Development -- Our Research Development program fosters establishment and development of interdisciplinary clinical and translational teams, projects and programs. Activities include active team-building, support for interdisciplinary project development, pilot funds for project initiation, project oversight, and assistance with strategies for securing sustainable funding.
SC CTSI Translational Research Informatics -- Our Translational Research Informatics group provides centralized infrastructure to help researchers manage, share and analyze large data sets in and across SC CTSI partner institutions. Services include data transfer and management; assistance with data publication, discovery and querying; and use of translational knowledge bases. We offer collaborative research services including space on the SC CTSI wiki/intranet; services such as mailing lists; and Electronic Research Data Capture (Redcap) service for self-managing data, data capture forms, reports and surveys.