DOCRO provides a full range of services to support the development, validation, clinical trials, and commercialization of in vitro diagnostic tests within our FDA/CLIA/ISO-9001/ISO13485 compliant Quality System.

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Regulatory Strategy Expertise
FDA Negotiation
Clinical Trial Protocol Development
Clinical Site Recruitment
Clinical Trial Management
Statistical Planning and Analysis
Final Clinical Trial Reports
Regulatory Submissions
Quality Manufacturing Audits

Websites of Interest

Association of Medical Diagnostic Manufacturers

American Association for Clinical Chemistry

U.S. Food and Drug Administration

Clinical and Laboratory Standards Institute

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