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 Provider
organizations such as Holston Medical Group bring willing
providers, deserving patients and tools to assure criteria
adherence, implementation, and enrollment for multiple studies.
HMG performs Phase II, III, and IV clinical drug trials as
well as device trials. The main benefits aside from building
evidence medicine are: 1) standardizing care in the group
through clinical guidelines and/or algorithms, 2) providing
care to patients through physical exams and visits, diagnostics,
medicines and/or devices and direct remuneration, and 3) presenting
a significant revenue stream to the medical group.
HMG has done clinical trials for six
years. They have 48 ongoing trials throughout their multi
specialty group, approximately 600 patients enrolled, seven
employed people in the department, and an income stream in
the seven-figure range annually. HMG has received awards in
excellence in several studies and are proud to have participated
in studies such as ALLHAT, Accord, and others.
HMG takes the following steps to ensure
quality control and compliance. The following areas are addressed:
(1) Define the basic roles and responsibilities
of the sponsor, monitor, investigators and FDA as they relate
to the quality of clinical trials.
(2) Implement the regulatory, source documentation
and record-keeping requirements for clinical trials.
(3) Ensure that clinical trials are compliant
with GCP standards.
(4) Define methods for integrating changes
and updating SOPs.
(5) Comply with 21 CFR Part 11 and audit
computerized systems in clinical trials.
(6) Maximize good design practices for
medical documentation.
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