CLINICAL TRIALS

Overview
Products and Services
Service Fees
Lab Management

Overview

Today's clinical trials demand flexibility in order to react to changes in study design and meet essential timelines while maintaining the utmost in quality. Your Lab's Clinical Trials staff are skilled in working closely with customers to capture every detail. Our commitment to quality assures Standard Operating Procedures are strictly implemented and that current Good Clinical Practice (GCP) standards are adhered to throughout each project. Our service commitments include:

  • Responsive and reliable service
  • Guaranteed response times
  • A professional approach to maximize efficiency and effectiveness
  • GCP compliant processes and procedures
  • Customized client report formats
  • Exemplary customer service

The Clinical Trials Laboratory is very proud of the trials we have participated in and the companies we've assisted to develop new and improved infectious disease testing or instrument development - companies such as Abbott Laboratories, Baxter Biologics, Ortho Diagnostics and Roche Diagnostics to name but a few.

The Clinical Trials Laboratory can also provide information on securing the services of our Institutional Review Board (IRB) to review clinical trial protocols that make use of samples from a volunteer donor population.

Products and Services

  • Serum and EDTA repository specimens and CPD pedigree plasma units for research or further manufacture are available in small or large quantities. Specimen collection with other additives such as heparin can be arranged. Specimens can be coded or unlinked, random or negative, and are collected from a normal donor population. Positive marker specimens for hepatitis B, hepatitis C, HIV, Syphilis, HTLV-I/II, West Nile Virus and Chagas disease are also available. All specimen procurement processes have been reviewed and approved by Gulf Coast’s Institutional Review Board.

    Orders are routinely customized to meet client needs. Gulf Coast collects over 300,000 donations annually and can accommodate most orders with little or no delay.
  • All clinical trials personnel are trained in Good Clinical Practice (GCP) and Human Subjects Protection. Our procedures and processes are GCP compliant.
  • The National Donor Testing laboratory regularly participates as a testing site for a variety of infectious disease testing and equipment development protocols. Other clinical trial services may be available depending upon the scope.

Service Fees

For service fee information, please contact Steve Ruth at (713) 791-6202.

Lab Management

Robin Fuller has worked at Gulf Coast in a variety of roles over the years. She is very familiar with the blood banking industry and has a strong background in quality assurance. She works closely with clients and staff to ensure that Gulf Coast offers services of the highest quality that are in full compliance with GCP standards.