GXP Consultants, Inc.

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).

	SERVICES Overview Process & Facility Construction FDA Compliance Regulatory Submissions Calibration Validation & Testing IT Systems Safety & Environmental Risk Clinical Development Legal Finance PRODUCTS Process & Production Equipment Laboratory & Facility Equipment EDMS (E-Documentation) PROJECTS MANAGEMENT LINKS CONTACT MEMBERS
	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 Suite 8-620 Tustin, CA 92780 (714) 325-8896