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ALS
GCP-approved Pharmacology Unit meets
the FDA 21 CFR Part 11, ICH and FDA-GCPs. For:
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The
3E CRO of ALS Inc. located in Montreal has a GCP-approved Phase
I clinic. The clinic is smoke-free overnight inpatient facility
with full-control of the exclusion/inclusion criterion of light-smoker
when this population is allowed to participate (virtual visit:
link1 and link2).
Our clinical center is designed and equipped to meet strict
compliance with the First-in-man regulatory standards, which
is an asset for Phase 1 and complex bioequivalence clinical
studies, and the participants' safety. It is also convenient
for studies of long duration (i.e., Steady-state, escalating
dosage, monitoring and follow-up of safety observation). The
ALS Professionals are qualified and experienced in clinical
research to fulfill the ICH requirements. The procedures used
allow the full control of the clinical operations and to experiment
the study protocol as written, ensure a top quality as by the
ISO 9001 standards.
ALS team is well-known in the industry as expert and compliant
with Ethics and Guidance.
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.
- Archive the records/ documents for 25 years as per the
Canadian regulatory
requirements. |
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96 beds.
- monitored beds including 12 equipped for invasive clinical
studies.
- continuous monitoring through telemetry equipment.
- capability to store ECG data in FDA format. |
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In-house catering allowing us to provide controlled meals
for specific dietary requirements.
- The participants are well accommodated, they relax,
play games or do hobby activities the recreation time.
At the end-of-study visit the participants are thanked
for their efforts and for contributing to advance medical
research for healthier tomorrow living. |
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