The SIMR Clinical Trials Program brings together Sutter Health professionals and clinical trial sponsors to participate in innovative clinical research programs. Through SIMR, clinical investigators can depend on a strong infrastructure to support their desire to offer patients the latest investigative treatment modalities.

SIMR offers comprehensive management and clinical support services for conducting clinical research at Sutter facilities, including a fully staffed outpatient research facility. Since its inception in 1991, SIMR has enabled almost 1,000 Sutter patients to participate in experimental treatments otherwise unavailable to the public. With access to over 1,000 physician specialists and a 250,000-patient database, SIMR performs clinical trials in a wide range of therapeutic areas, including cancer, cardiology, endocrinology, infectious disease, neurology, orthopedics, pediatrics and other areas of research.

When Sutter physicians are interested in acting as clinical trial investigators, SIMR offers an experienced team of trial veterans to support the effort. A start-to-finish approach makes it easy for doctors with busy practices to maintain their interest in research without overburdening their schedules or staff. Services SIMR provides include:

Soliciting Trials
Protocol Review
Sutter Health Central Area Institutional Review Committee (IRC)
Financing and Contracting Coordination
Regulatory and Compliance Services
Participant Recruitment
Data Collection, Data Analysis and Reporting Systems
Research Pharmacy Coordination

Soliciting Trials | back to top

SIMR conducts ongoing research into upcoming clinical trials that may be suitable to Sutter's medical specialists, community practice model and patient populations. By keeping a database of interests and qualifications on physicians who express interest in serving as a clinical trial investigator, SIMR can actively look for trials that match our researcher profiles.

If you are interested in participating in upcoming clinical trials, contact SIMR at (916) 733-8930.

Protocol Review | back to top

Understanding the requirements of a clinical trial and logistical, technical, patient population and investigator resources is a critical first step to success. SIMR staff reviews protocols with medical specialists and assesses the feasibility of participating.

Sutter Health Central Area Institutional Review Committee (IRC) | back to top

In 1996, a single regional Sutter Health Central Area Institutional Review Committee (IRC) was established to review all research involving human subjects. Human subject review is mandated by federal and state law to protect the rights and welfare of human subjects involved in research.

The IRC operates under the policies and procedures that conform to federal and state laws and regulations. The regulations require that the committee have members from each participating institution, non-affiliated community members, non-scientist members and be comprised of both men and women.

The committee regulates the study and investigator as it pertains to protecting the participant. The IRC is responsible to insure justice, beneficence and safety in the clinical conduct of research. To optimize research for the investigator and the participant, the IRC is available 24 hours a day, 7 days a week.

To submit a proposed research project application to the IRC, please contact Pat Lamay, Human Research Compliance Specialist at lamayp@sutterhealth.org.

For more information about the Sutter Health Central Area Institutional Review Committee, call the SIMR Office of Research Administration at (916) 733-3864, #4 or ext. 79297.

Financing and Contracting Coordination | back to top

SIMR acts as a liaison between the investigator and sponsor to handle financial details and coordinate contracts.

Regulatory and Compliance Services | back to top

Preparing reports that undergo scrutiny by sponsors and oversight boards, committees and agencies is a cumbersome aspect of research that prevents many practicing physicians from pursuing studies and clinical trials. SIMR offers the staff and information technology resources to prepare, write, file and manage regulatory reports for the Sutter IRC, sponsors and government agencies.

Participant Recruitment | back to top

SIMR coordinates recruitment activities through marketing efforts, community outreach and communication through Sutter's physician network and other avenues.

Data Collection, Data Analysis and Reporting Systems | back to top

SIMR resources include sophisticated systems for collecting, analyzing and reporting trial data. In addition, SIMR staff includes a Statistical Methods Specialist who ensures data is prepared properly for sponsor reporting.

Research Pharmacy Coordination | back to top

SIMR handles oversight of ordering, stocking, logging and preparing necessary reports for investigational drugs and medical devices used in a study.

The Clinical Trials program is dedicated to assuring that all scientific investigations are conducted in a rapid, efficient and professional manner.

For more information regarding our clinical trials or to participate in one of our clinical trials, please see "Participate in a Study" or call the SIMR Clinical Trials Program at (916)733-8930 or 1-888-777-8820.

For more information on the Sutter Cancer Center's Clinical Trials, please click here.