Our Mission: We will conduct clinical research trials in the field of infectious diseases with particular focus on the safety and comfort of our participants, quality of our data, and integrity of our results. We partner with pharmaceutical companies and government agencies to develop experimental therapies for both the prevention and treatment of infectious diseases.
International Conference on Harmonization Good Clinical Practice and FDA CFR 21
CARE-ID strives to comply with ICH GCP’s, FDA, IRB and other regulatory requirements by working closely with each Sponsor and CRO during all routine monitoring visits, ensuring that all source documentation and regulatory correspondence is accurate. All physicians and staff are required to take a GCP training course annually. Most recently, they have all completed the NIH “Human Participant Protections Education for Research Teams” online training in March 2005. Standard Operating Procedures guide the investigator, coordinator and all support staff in performing their daily duties. To date, no Investigator has been audited by the FDA, and therefore has not been issued FDA form 483 or form 482. CARE-ID will work with the Central IRB chosen by the Sponsor when it is made available. If a central IRB is not designated, then CARE-ID will work directly with Chesapeake Research Review, Inc. located in Columbia, MD. In April 2005, David Wheeler, MD and Donald Poretz, MD founded the Clinical Alliance for Research & Education – Infectious Diseases, LLC (CARE-ID). Combined they have 64 years of clinical research experience to include antibiotic, antiviral, and vaccine development, as well as prevention methods.
CARE-ID, formerly Infectious Diseases Physicians, Inc. IDP Research, was founded in 1980. The office is located next to the main office of Infectious Diseases Physicians, Inc. CARE-ID has the personnel and facilities to organize and execute Phase I-IV clinical trials in the out-patient setting. The office suite has a welcoming waiting room, three exam rooms, two administrative offices, a dedicated monitor room, and a large front office space that securely houses all regulatory documents, source documents, the refrigerator for drug storage, and dry ice machine. CARE-ID also has access to a four room outpatient infusion clinic. These rooms are equipped with hospital beds or infusion recliners, cable television, and are available for Phase I and II pharmacokinetic trails that require 24-hour visits.
CARE-ID investigators have conducted more than 100 protocols, phase I-IV for both industry and government. In addition to the 400+ HIV infected individuals cared for by the IDP clinical practice, the following organizations refer subjects to CARE-ID for research trials: Inova Juniper Program (500+ clients), Casey Clinic (Alexandria Health Department, 150+ clients), Kaiser Permanente (200+ clients), and private physician practices. Other potential subjects refer themselves by reading IRB approved advertisements provided by either the Sponsor or CARE-ID and performing internet searches for available research protocols.
The staff includes Tracey Barrett, RN, BSN and Cindy Coates, CCRC. CARE-ID’s hours of operation are from 8am to 5pm EST Monday – Friday. The Research Coordinator on-call is available by pager 24 hours per day in the event of a medical emergency. CARE-ID physicians have privileges at Inova Fairfax Hospital, a tertiary care center, just ¼ mile from the office. It is a full-service hospital.
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