Community Clinical Research is consistently among the top enrolling sites on multi-site protocols. We have a clear understanding and appreciation for the timely completion of studies. Before beginning each protocol, we develop a plan for enrollment and retention.
In addition to our research database which encompasses Central Texas and reaches as far as the Houston and Dallas metro areas, we have strong relationships with a variety of traditional marketing and new media companies. We have three full-time community liaison specialists who work with individual subjects, their families, and referral sources to enhance both enrollment and continuity of care.
Our principal investigator, David Brown, M.D., routinely speaks at various professional and patient advocacy / support organizations to inform the public about our research projects.
PHASE I CAPABILITY
In addition to conduction Phase II-IV CNS clinical trials, Community Clinical Research successfully conducts a number of Phase I safety trials and assists in protocol development for a variety of companies.
We conduct these studies at our facility located within 5 miles of a general hospital. Our facility is staffed 24 hours with nurses and laboratory staff who work with our Clinical Research Coordinators to provide the precision required by Phase I trials. We also work closely with a local Ophthalmologists for protocols requiring ophthalmologic examination and data collection.
Advanced Cardiac Life Support (ACLS) trained staff are always on duty. The site has a full crash cart and defibrillator. Phlebotomists and laboratory staff have completed FAA required hazardous material training.
Our research team has extensive experience with Phase I trials and has specialized equipment necessary for advanced protocol execution, including:
- Tabletop and refrigerated centrifuges
- Scientific freezers (-20 and -70) with back up solar power
- ECG equipment
- Medical Refrigerators
- Body Composition Scale
- Temperature monitors and daily monitoring/loggers
- Min/Max Temperature Indicators for IP storage areas
- Designated, temperature controlled IP storage areas
- EEG equipment
- Non-invasive blood pressure monitors and pulse oximeters
Our facility has two designated private offices for onsite Sponsor and CRO monitoring/auditing.
Strict protocol adherence and production of data requiring minimal monitoring time and sponsor data queries require a multi-faceted approach to quality assurance.
Patient care staff undergoes rigorous training that includes inservices on specific protocol requirements, and other topics related to mental illness, psychiatric medications, side effects, and good clinical practice in research. We have unique and aggressive programs in place to train staff, to self-monitor / audit our site, and to insure that our site produces clear data for clean CRF completion and reporting.
We would be glad to discuss in detail these programs. We employ a full-time Regulatory Specialist who centrally handles all IRB issues for the study coordinators.