Services of the Clinical Research Institute
Our office has experience in conducting Phase I through Phase IV pharmaceutical and device, industry-sponsored, as well as investigator-initiated research protocols.
The nurse coordinators are highly trained, have extensive experience both as nurses and as coordinators and all are, or will be, certified through the Association of Clinical Research Professionals (ACRP).
The CRI can assist with the following:
- Study design: Based on statistical considerations from the very beginning
- Data analysis: By a biostatistics/epidemiology group
- IRB submissions: No study with humans can be done without IRB approval. The CRI has the personnel to prepare all necessary IRB submissions
- Study conduct for in-patient and out-patient projects: From recruiting subjects, scheduling appointments, performing procedures like blood draws, BMD tests, EKGs, etc., to collecting data and assisting with reports and manuscript preparation
All proposals will be reviewed for:
- Feasible: Adequate subjects & expertise, affordable in terms of time & money and manageable in scope
- Novel: Confirms, refutes or extends previous findings
- Ethical: Acceptable treatment of subjects with adequate confidentiality
- Relevant: Related to advancing scientific knowledge, clinical & health policy, or future research
Education and Training
Conducting research requires knowledge and understanding of the process and the federal regulations involved. The CRI offers a variety of educational programs at multiple experience levels. Some are formally approved courses and electives; others award certificates, however, most include practical application of learned skills.