Atlantic Life Sciences, Inc.




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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:
- 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.
- 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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