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Recently
renovated, ALS Inc. has a smoke-free
overnight inpatient facility.
It allows controlling the criterion of light-smoker when allowed
to participate in the clinical trials. The compliance with the
study protocol, the procedures , the study rules and the safety
of participants are our top priority.
Our clinical center setup is appropriate for the Phase 1 and
First-in-man clinical studies which is an asset for bioequivalence
studies. Our center is also appropriate for studies of long
duration (eg. Steady-state, escalating dosage, monitoring and
follow-up of safety observation). It is designed to meet strict
compliance with the First-in-man
regulatory standards. The
personnel are qualified as by the ICH requirements and well
experienced in clinical research. The procedures used allow
the full control of the clinical operations and to experiment
the study protocol as written, to record the data clearly.
The inpatient facility is equipped to meet the FDA 21
CFR Part 11
and GCPs standards:
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it is temperature controlled area and 6 cycles of circulating
air per hour (Quebec Construction Code).
- temperature, humidity, access controlled
on-site pharmacy (Armor-plated Safe Vault).
- temperature, humidity, access controlled archive facilities
both on and off site. We archive the records/ documents
for 25 years as per the Canadian |
regulatory
requirements.
- monitored beds including 6 equipped for
invasive clinical studies.
- continuous monitoring through telemetry equipment.
- capability to store ECG data in FDA format.
- At the end-of-study visit the participants
are thanked for their contribution to advancing medical
research and better global health. |
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In-house catering allowing us to provide controlled meals
for specific dietary requirements.
- The participants are well accommodated, and during the
recreation time they relax, play games or do hobby activities. |
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