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ISO 9001:2008 CERTIFIED.

RCRI Services:

Regulatory Affairs

Regulatory Affairs

Clinical Trial Design & Management

Clinical Trial Design & Management

Database Development & Compliance

Database Development & Compliance

Reimbursement Strategy and Implementation

Reimbursement Strategy and Implementation

Health Economics

Health Economics

Quality Systems & Compliance

Quality Systems & Compliance

Biostatistics

Venture Capital Due Diligence

Venture Capital Due Diligence

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952-224-2263

Clinical Database Development & Compliance

CUSTOMIZED DATABASE DEVELOPMENT AND COMPLIANCE

Let the RCRI team help you design, develop, and/or customize your 21 CFR Part 11 compliant database.

Development Capabilities

Creation of 21 CFR Part 11 compliant databases

R-Cascade (located at RCRI or customer site)
Clindex (located at RCRI and/or access remotely via EDC)

Custom Study Progress Report development
Customized application development
SAS Code Programming

Compliance/Auditing capabilities

Validation of RCRI or customer developed databases
SAS Code Validation (RCRI or customer developed)
Auditing

21 CFR Part 11 gap analysis
Database development SOP Audit

Special services

RCRI can provide Clindex software services to customize your clinical trial software
RCRI can provide custom solutions for exporting data from clinical studies managed by RCRI into your internal/proprietary study management systems

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Database Development

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RCRI® RESOURCES

• ISO 9001:2008