Clinical Trials Unit Support Services
The Clinical Trials Unit (CTU) has the capabilities to successfully support the following wide range of clinical trials:
- Phases: I, II, III, and IV
- Types: Diagnostic, Proof of Concept, Safety, Nutrition, Prevention, Treatment, End of Life
- Areas of Study: Cardiology, Endocrinology, Oncology/Hematology, Infectious Diseases, Neurology, Nephrology, Ophthalmology, Pediatrics, and more…
Other Support/Ancillary Services:
Protocol Development and Implementation
CTU Protocol ImageThe CTU offers a broad range of tools, templates, and consultation services to assist investigators in writing and developing clinical trial protocols that are in compliance with regulatory/GCP requirements.
Design and Monitoring of Pharmacokinetic Studies
The infrastructure at CTU supports safe and efficient conduct of Phase I clinical trials that require close and careful monitoring of healthy volunteer research subjects, including vital signs, blood chemistry, ECG, and other relevant clinical parameters.
Experienced Clinical Trials Team
Experienced and diligent CTU staff ensure that the clinical trials meet the highest standards of ethical, legal, and regulatory requirements.
Investigators at CTU can conveniently access the biostatistical consulting services provided by the Office of Biostatistical Support at Ochsner.
Local IRB Oversight
All studies involving human research subjects at the CTU will require approval and ongoing oversight by the Ochsner Institutional Review Board (IRB). The Ochsner's IRB is a component of the Ochsner’s Office for the Protection of Research Subjects, which is housed in the Institute for Clinical Research. Research protocols for IRB review can be submitted conveniently using Electronic Research Study Application (ERSA) system and are routed, reviewed, and finalized electronically for faster outcomes.
Experienced Budget/Contract Team
The experienced staff of the Office of Grants Management and Development (OGMD) can assist research investigators in ensuring that budget negotiations and contract execution processes are accomplished efficiently for the timely start-up of clinical trials. OGMD can also help with activities such as grant writing, preaward fiscal planning, and postaward fiscal monitoring.