Statistical Support for Large-Scale Clinical Trials

CLICK HERE for a comprehensive description of SABER services, including:

• Statistical expertise
• Data management
• Project management
• Clinical monitoring
• Software development
• Clinical research administration

As with any clinical trial, investigators should complete the Clinical Trials Support Office's CTSU Intake Form. Information provided on this form will help that team determine whether your project data and statistical needs are a better fit for SABER or MICHR, and an introduction will be sent to the appropriate units.

SABER’s focus is on multi-site studies and it works most efficiently when handling those; however, SABER is capable of supporting, and currently supports several, single-center studies. As part of the partnership with MICHR, we have increased our focus on supporting those single-center studies that require a 21 CFR Part 11 compliant data collection system.

Through the partnership between the School of Public Health and the Medical School, SABER can provide core administrative functions for Medical School investigators, with free initial consultations on study design and proposal development. All program-related activity is funded by sponsored programs (grant awards). SABER would partner with the investigative team and be supported on the submitted grant for the personnel and effort required to manage the roles that SABER has agreed to manage for the study.

As a part of its CTSA award, MICHR offers the following free services:

• Regulatory support consultation and training
• Research development consultation and grant editing services
• Consultations on data management, partnership development, and biostatistics support
• Connect U-M faculty with national Clinical Research Networks (CRNs) multi-site trial opportunities
• REDCap consultations and software hosting

MICHR also provides other research support services priced on an hourly basis, including regulatory support, statistical support, and study monitoring. CLICK HERE for a more comprehensive list of MICHR services for clinical trialists.

Much of the information that SABER will need is collected on the CTSU Intake Form – the type of study, the program period, and the services needed. Other data that SABER will collect will be details about the number of patients and sites involved, the scope and type of the data collection, requirements for the Observational or Data Safety Monitoring Board and regulatory and safety reporting, and types of ancillary activities that may be involved, such as biorepository support or central pharmacy management.

SABER can definitely assist with developing a protocol. We encourage investigators to reach out to us as early in the process as possible. If we work together, part of our role will be to help prepare your study protocol, from helping to draft one from scratch to reviewing and commenting on an existing one. However, this service is not available as stand-alone support for a grant that would not include SABER's services. 

Both SABER and MICHR can provide stand-alone statistical services for a research study. This type of support is standard practice for MICHR; while not the typical approach taken by SABER, it can be a good fit in some cases. The Clinical Trial Support Office will help you determine which statistical support service is right for your project, but if you need additional information please contact:
 
MICHR Biostatistics Support: Shokoufeh Khalatbari at skhalat@med.umich.edu.
 
SABER Biostatistics Support: Giselle Kolenic at gkolenic@med.umich.edu.

SABER does not have an empaneled DSMB available for use as needed. As part of study development with partners, SABER will help identify DSMB members to impanel a Board that meets the sponsor’s requirements. SABER will also help contract and manage that DSMB during the course of the study if awarded.