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Medical Device Clinical Trial Design & Management

CLINICAL TRIAL DESIGN & MANAGEMENT

Database Design and Management

The Regulatory & Clinical Research Institute specializes in creating custom databases and reporting tools quickly and cost-effectively. We start from a core technology that can be tailored to meet the specific needs of your study.

Our Database Design & Management Capabilities Include:
  • Development of custom 21 CFR Part 11 databases for clinical studies
  • 21 CFR Part 11 database validation services
  • Statistical programming support using SAS® software
  • 21 CFR Part 11 gap analysis
RCRI® will:
  • Develop database system
  • Validate it extensively
  • Train your data entry staff
  • Provide training on how to utilize the database on an ongoing basis for postmarketing purposes
The data belongs to you.

Depending on your needs, we will work with you throughout the clinical study or at specific points, whether at RCRI® or at your company.

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