Clinical Trial Site Coordination | Clinical Trial Management | Clinical Studies
Clinical Trial Site Coordination
Individual physicians and physician practice groups participating in regulated clinical trials can benefit from our experience. The institute's dedicated staff of clinical trial coordinators can add value for both physicians and investigators with their years of clinical research experience. Increased capability, cost reductions and a reduced risk of protocol deviation are some of the benefits of utilizing a clinical trial coordinator. For additional information on clinical trials site coordination services, please contact Teresa Turbeville.
Consultation
- Educating both investigators and their clinical staff in regulations and requirements of FDA trials
Site Organization
- Providing procedures and guidance for staff
- Patient education
- Patient scheduling management
- Integration of special protocol requirements into clinic
- Liaison with hospitals for introduction of new technology
- Assisting with preparation for FDA audits
Collection of Data
- Developing and acquiring appropriate source documentation
- Transcription of study data onto trial report forms
- Facilitation of monitoring visits
Compliance
- Facilitating or managing initiation and subsequent reporting to sponsors
- Hospital regulatory boards
- FDA and other applicable parties
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Clinical Trial Management
Our experienced staff of regulatory consultants and clinical research associates can design and manage multi-site study trials for both drug and IDE trials. For additional information on clinical trial management services, please contact Teresa Turbeville.
Protocol Design
- Consultation on regulatory approval strategies
- IDE protocol design
- Collaboration with principal investigator to identify clinical evaluations and endpoints
- Identification of validated patient questionnaires
- Interface with FDA
Study Initiation Tasks
- Organization of investigators' meeting
- Site clinical trial agreement facilitation
- Site initiation
- Development of study book and forms
- Study-specific information
- Patient recruitment strategy consultation
Database Design and Management
- Programming of database
- Data input
- Data verification
- Development of study-specifics
- QA for data integrity
Monitoring of Site Compliance
- Site visits to monitor data integrity
- Data verification
- Protocol and regulatory compliance checks
Preparation of Regulatory Reports
- Prepare reports and notifications of adverse events and protocol deviations
- Annual and final reports
- Pre-market approval application
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Clinical Studies
Texas Health Research & Education performs non-regulated clinical studies for investigators. For additional information regarding clinical studies services, please contact Teresa Turbeville.
Study Components
- Study design data collection (bone mineral density data, X-ray measurements, collection of patient questionnaires and patient interviews)
- Statistical analysis
- Preparation of presentations
- Publications of study results
Examples of Studies Performed
- Learning curve for minimally invasive spine surgery
- Diagnostic criteria for thorascopic fusions
- Comparison of perioperative data on open vs. laparoscopic spinal fusion
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