Clinical Development Services
GXP Consultants is committed to providing our clients with a superior level of clinical study management, monitoring, data management, and statistical services for all Phases (I, II, III, and IV) of clinical research and development, maintaining compliance with Good Clinical Practice and applicable current regulations and industry standards.
GXP Consultants is the solution for your US and European clinical research and development needs, offering:
- Clinical Program Strategic Planning
- Clinical Study Development, including Protocol Development, Case Report Form Design, Investigator Recruitment and Qualification, etc.
- Clinical Study Management
- Investigational Product Shipment and Inventory Management
- Investigational Site Contracts and Financial Management
- Monitoring, from Pre-Study and Site Initiation Visits through Study Close-Out
- Database Design and Construction
- Clinical Data System Fully Compliant with 21 CFR Part 11
- Data Management, including Data Entry Capability for Paper CRFs or Electronic Data Capture (EDC) and In-Process Quality Control
- Statistical Support
- Medical Writing, including Clinical Study Reports and Investigator's Brochures, etc.
- Quality Assurance Audits
Each of our lead experts in clinical research and development has more than three decades of experience working with companies ranging in size from emerging-growth to major pharmaceutical companies. More than a decade of experience is the standard for our clinical research professionals.
GXP Consultants responds quickly and effectively to initiate clinical trials and complete them on schedule. Our staff is uniquely qualified to help our clients assess and define cost-effective, practical, but innovative (where appropriate) approaches to clinical development. GXP Consultants can assist you with any or all of your clinical research and development needs, whether you are involved in the development of drugs, biologics, or medical devices (including in vitro diagnostics).
13681 Newport Avenue
Tustin, CA 92780