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Just In Time – The Patient First Approach

THE HISTORY - “JUST what the doctor ordered”
Presently, the clinical research process involves lengthy time spans
between collecting the documentation needed for IRB approval and
identification of a potential patient. In many cases, this drawn out process
never results in the identification of an eligible patient, particularly in cases
of rare disease indications where time is most critical. Thus, timely research
allows for better clinical trial results and positively impacts the quality of life
and survival of the patients.
Pharmatech’s new approach in conducting clinical research for those studies with rare disease indications is:
Just In Time (JIT)
THE PROGRAM – “Are you part of the IN crowd?”
The JIT program will revolutionize the industry and it will only be available to members of the Pharmatech Research Network and the studies we conduct. To participate in the JIT program, it is essential that each network member commits to:
- Research training
- Prescreening of patients
- Protocol understanding
- Utilization of a central IRB
- Maintenance of updated regulatory documents: Master Research Agreement,
Clinical Laboratory Improvement Amendments (CLIA), Normal Ranges, Confidentiality Agreement, Medical Licenses, and
Curriculum Vitas
TIMING – “TIME is of the essence”
In clinical research, timely patient care is essential. At the site level, time is
better spent on those studies where a potential patient is already identified.
With JIT, once a patient is identified as a potential candidate for a study, a
quick turn around of IRB paperwork for approval will ensure no delay in
standard of care. The time needed to complete a JIT research trial will
dramatically decrease the overall research process. Sponsors benefit from
quicker drug approvals, while sites benefit from more time to participate in
multiple studies.
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