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Advanced Research /Pioneer Clinical Research - Conduct of Phase II-IV clinical Research Trials for our associated Pharmaceutical company and Clinical Research Organization
What are Clinical Trials we do?
In Phase 2 trials, the experimental treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow it to be used safely. Data will be used by the FDA to determine if they will approve the marketing of the investigational product.
In Phase 4 trials, Once the FDA has approved the investigational product and the medication is available for prescription, post-marketing studies begin to delineate additional information, including the treatment's risks, benefits, and optimal use.
Capabilities of Pioneer Clinical Research
- Local Laboratory Services and Central Laboratory Services (Quest Diagnostics or others)
- Local Laboratory on-site for blood work-up, processing and shipment (OSHA, biomedical waste and IATA trained staff)
- Centrifuge, Refrigerated Centrifuge, -20 degree Celsius refrigerator, 2-8 degree Celsius refrigerator with alarm sensors
- Ultrasound Technologists
- Fully equipped Crash Cart
- Access to X-ray, Ultrasound, CT scan, and MRI and other testing
- Access to Cardiology related testing - Ultrasounds, ECHO, Nuclear testing (SPECT), Stress testing and other treadmill testing, 24 hour Holter, ABI, etc. and cardiology technician
- Dialysis unit capabilities at satellite site location
- Medical Consultation in Cardiology, Pulmonology, Gastroenterology, Endocrinology/Diabetes, Nephrology/HTN
- Secured 24 hour surveillance medical facility monitored by video camera
- Secured drug storage, temperature controlled areas equipped with alarm sensors, in addition to, another secured storage room within for additional security with enhanced limited access/alarms
-Extensive Patient/Subject Research database for our clinical trials
- Secured storage area for Regulatory Files, Source documents and Medical Files of our Research Participants
- Fully Equipped Exam rooms for physicians
- Nurses Triage area for obtaining Height, Weight, Blood Pressure, Pulse, Pulse Oximetry, temperature, hanging IV's, infusion and other data collection
- Relaxing IV infusion /PK draw area with facilities with 24 hour coverage capabilities
- All machines are calibrated, such as the scale for Ht/Wt/BMI measurements, all EKG machines, Centrifuges and Spirometry machines etc.
- EKG room for comfortable area to obtain good quality tracings, on-site cardiologist for prompt readings as necessary by the study
- Conference Room for Meeting with staff and physician and group training for various protocols
- Quite Room for our Clinical Research Associate for routine monitoring visits with Access to High Speed Internet, computers, phone, fax, and printer with fast copy and scan to email/file features to facilitate their needs to communicate with Sponsor/CRO during their visit as needed
- Comfortable Subject Waiting room with cable television and literature about various medical condition for the patient's knowledge
- Data Managements via our well experience staff/physician to promptly enter research data into Electronic Data Capture (EDC) system and answer Queries
- Our well experienced and dedicated staff and physicians also ensure that we have access to any other facilities, machines and equipment's as need for specific clinical research studies as required
- Lunch Room area with fresh coffee, bottle water and drinks for all our staff, subjects and associates