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
All proposals will be reviewed for:
- Feasible: Adequate subjects & expertise, affordable in terms of time & money and manageable
- 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
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.