Stat CRA Inc. is a Site Management Organization (SMO) for clinical trials. We work with qualified investigator to conduct clinical trial for pharmaceutical and biotechology companies in Chicago and surrounding areas. We work with physicians from a variety of therapeutic areas to safely and accurately execute clinical trial protocols. We specialize in phase III-IV clinical trials. We handle all of the regulatory requirements for the study so that the physician can focus on what he does best, that is patient care. We provide a dedicated study coordinator for each site. Our coordinator will screen the site’s database for potential candidates and handle screening, enrollment, and scheduling all study visits. We differ from other SMOs in that we offer remote clinical trial visits. Our study coordinator will visit the subject in their home, office, nursing home, assisted living facility or anywhere the subject may be to supplement regular clinic visits. We use PC based ECGs to perform in home ECGs for clinical trials. We are able to perform many procedures that would be conducted in the clinic, in the subjects’ home. By providing this option, we are able to follow subjects in clinical trials long after completion of treatment to collect much needed safety data. Our visits can include subjects who may be placed on hospice care.
We provide a wide range of clinical trial services including:
- Investigator and Site Selection
- Investigator database screening for subject participation
- IRB submissions including any amendments
- Scheduling subject research visits and follow-up including home visits if allowed by protocol.
- Perform PSSV with sponsor/CRO at investigator site
- Perform SIV with sponsor/CRO at investigator site
- Attend investigator meeting
- Adverse event assessment, documentation and reporting both in home and on site
- SAE documentation and reporting including collection of data from outsite facilities
- Query resolution
- Timely CRF documentation including experience with EDC and RDC
- Ensure access to original source documentation
- Deviation and violation reporting
- Ongoing site training and documentation including maintenance of the delegation of authority log
Our staff consists of experienced clinical research professionals and clinicians who receive continuous training to ensure compliance with ICH GCP and 21CFR part 50 regulatory requirements. All study staff must be GCP trained and have IATA training if shipping to central labs.
Stat CRA provides expert home clinical research services for adult and pediatric patients in the following areas:
- Infectious disease
- Respiratory (including subjects on mechanical ventilation)
- Burns and Plastics (including wound care)
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