Services and Capabilities
Faculty and staff biostatisticians enhance the scientific rigor of clinical trials and studies and resulting publications by providing statistical and clinical trials methodological expertise to the design, analysis, and dissemination of research findings. In addition to their traditional role as providers of sample sizes and P-values, SABER statisticians play a critical role in guiding the design of clinical studies. We also provide thorough and compelling statistical analyses using contemporary statistical methods. Our meticulous designs and analyses will ensure that the results of this study are broadly accepted, and our application of rigorous statistical reporting standards and processes will ensure that our results are robust and lead to timely dissemination of results.
For data capture, SABER uses REDCap Cloud (RCC), a 21 CFR Part 11-compliant data entry and management system which ensures
sufficient controls (e.g., audits, system validation, audit trails, electronic signatures
and documentation of software and systems) for electronic data essential for submissions
to the FDA and any project requiring rigorous data management processes. REDCap Cloud is the only fully 21 CFR Part 11-compliant system at UM and it is a commercial
product with monthly access fees that are required costs to the study. SABER holds
the master service-level agreement for this commercial system and works with investigators
to identify the appopriate service tier and monthly access fees for the their study.
After a protocol is finalized, our clinical data managers prepare draft study-specific case report forms (CRFs) and verifications checks specific to each CRF. SABER uses a library of standard CRFs and modules which use common data elements (CDE) that meet CDASH requirements. This provides efficient database development for common and standard data, allocating more time toward the design of study-specific forms. Clinical data managers employ rigorous internal testing procedures for CRFs and associated data checks prior to implementation of new or revised forms, and create and maintain a data management plan that records all project specifications, data decisions and data handling.
SABER's project management team offers leadership in clinical trial management. We
serve as the primary day-to-day resource for the project's principal investigators,
site coordinators, vendors, fellow collaborators and the DCC work group. We help write
the study protocol and manual of procedures, shepherd study sites through regulatory
approvals, work with study team and data managers to move from protocol to database
design, monitor study progress, assist in DSMB reporting, and help the team to close
sites and finalize data. Project managers maintain the Trial Master Files and prepare
IRB and FDA IND/IBE submissions, updates and annual reports. We are responsible for
ensuring that all required study tasks are accomplished in a timely manner, and systematically
monitor and evaluate various aspects of the DCC activities against regulatory quality
standards. Project managers track tasks, responsibilities, timelines, milestones,
and address potential obstacles to fulfilling short- and long-term study goals. They
also provide clinical monitoring support as needed.
SABER uses a risk-based monitoring approach which includes on-site and remote clinical monitoring to assess database accuracy compared to source documents and to monitor adherence to regulatory and study procedures. In particular, our monitors review eligibility and safety information, as well as site compliance with regulatory requirements, good clinical practices, and other areas that lead to success for both the site and the sponsor. We also assist with start-up activities of clinical study sites and on-site coordinator training. SABER follows an adaptive risk-based approach to site monitoring which uses statistical analyses to identify sites requiring additional monitoring.
SABER's software development team supports the collection and organization of data, developing customized applications and reports that are used by collaborators and internal SABER staff. Example applications include a serious adverse events (SAE) narrative system that incorporates MedWatch forms, drug supply and dispensing, and scheduling calendars that are customizable to each study. Reports allow daily or monthly dissemination through email or websites of study data in formats that enhance study investigator and sponsor review of study data and progress. We collaborate in the development of requirements, databases (Oracle, Postgres), applications (Java, Angular), reporting, and public and private websites (JSP and Spring). SABER developers interface with the university's IT groups for IT operations, database administration, and information security. Utilizing Agile processes, developers work closely with project managers, data managers, internal leadership, and external partners to define work to be accomplished, gather feedback along the way, and validate completed work products.
Clinical research administration
SABER's research administrators provide established infrastructure and services for study administration and operations and for communication among study stakeholders. We have experience in setting up face-to-face meetings, as well as virtual meetings through teleconferencing and webinars, for investigators, data and safety monitoring boards, site coordinators, and other study committees. We maintain project-specific contact logs and email distribution lists necessary for efficient communication. We assist site coordinators and PIs with gaining access to the clinical database and other project-specific software applications. We develop specimen barcode labels and shipping manifests in collaboration with SABER data managers and study teams to ensure proper identification and tracking of precious specimens. We administer site payments based on form completion reports and honoraria for DSMB members. We assemble, format, and publish data safety monitoring reports, and create and maintain project-specific websites both for the public and for project team use.