Clinical Research Operations

SCCR has the clinical and operations experience and expertise to conduct Site-Based Research (SBR) at Stanford and Clinical Coordinating Center (CCC) activities for multi-center, digital and decentralized clinical research studies. The integration of both SBR and CCC within SCCR allows shared learnings and enhances the ability of our staff to define efficient processes and procedures across the entire enterprise. We have common SOPs, as well as shared Quality & Compliance support and Education and Training for study teams.

We have expertise in the following therapeutic areas:

Site-Based Research

Our SBR team provides wide-ranging skills and expertise in the conduct of research at Stanford or with a decentralized methodology. SCCR staff members partner with study investigators to build and maintain a scientifically impactful study portfolio and execute studies in an efficient and high-quality manner.

Specifically, the SBR teams provide:

• Facilitate strategic growth and management of clinical research portfolios to meet research program goals

• Assess all new studies for operational and financial feasibility

• Provides support and management of regulatory compliance, budget and scope of work creation, contract negotiations and grant proposals

End-to-End Study Conduct Support and Surveillance

• Develop and maintain efficient systems, processes and workflows enabling the successful execution of studies.

Coordinating Center

Our CCC team has nearly 10 years of experience in the design, conduct and management of multi-site and decentralized studies. SCCR leads CCC activities for studies funded by the National Institutes of Health, industry, US Department of Defense and scientific foundations. Industry funding includes pharmaceutical and device companies, technology and biotech companies and start-ups. We coordinate FDA regulated drug and device studies and support applications for regulatory approval for new drugs and devices.

SCCR regularly collaborates with Data Coordinating Centers (DCCs) at Stanford and other academic centers to successfully and efficiently support both CCC and DCC resource needs for specific projects.

Specifically, the CCC teams provide: 

• Scientific Trial Leadership
• Project Management
• Project and Quality Management Plan Development
• Study Design and Protocol Development
• Budget and Scope of Work Development
• Resource Management
• Study Site Feasibility and Selection
• Study Site Management from Start-up to Close-out
• Participant Recruitment and Retention, with a focus on targeted plans for diverse populations
• Vendor Oversight and Management
• Clinical Endpoint Adjudication
• Regulatory Affairs Support

Study Documentation

• Electronic Trial Master File Management

Education and Training of Study Teams

• Development and support of investigators’ meetings
• Tailored training of site investigators and staff

Data and Safety Monitoring

• Pharmacovigilance (Safety Desk)
• Data and Safety Monitoring Board/Data Monitoring Committee Management
• Study monitoring

SCCR provides comprehensive CCC functions and activities to fully support clinical research programs. SCCR successfully partners with many Academic Research Organizations, industry teams and Contract Research Organizations to jointly establish and manage CCCs.