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Atlantic
Life Sciences is an industry leading successful CRO in the early
stage clinical research development services. Our 20 years of experience,
our expertise and deep knowledge of local and international guidance
qualify us to gauge how trial protocols manifest in real-life. Sponsors
can therefore plan and budget based on accurate projections, they
can meet their own deadlines and goals. We gained the reputation
of accomplishing complex studies on time and get them done right
from the first time. We do only what we know very well. All our
clinical studies pass the regulatory review successfully.
1.
Phase
0 / First-in-man and
Phase
I including biosimilar clinical
studies
ALS Inc. has a GCP pharmacology
unit located in Montreal. It is equipped and designed to
meet strict compliance with the First-in-man regulatory standards.
Its setup allows the full control of the clinical operations
and to experiment the
protocols as
written, to record the data clearly. In our understanding this
is a criterion for the quality of clinical conduct minimizing
the variations resulting from the standardization of the clinical
operations, the safety of
participants and more. The outliers record follows the FDA definition.
Our center is appropriate for studies of long duration: steady-state,
escalating dosage, monitoring and follow-up of safety observation.
The team is qualified as by the ICH requirements and well experienced
in clinical research.
2.
Bioavailability
/ Bioequivalence studies
(generic and biogeneric products)
ALS has a-recently renovated, smoke-free overnight
inpatient facility. It allows controlling the
criterion of light-smoker when allowed to participate.
Our expertise of phase 1 clinical trials is an asset for
bioequivalence and comparative biosimilar studies. The
compliance with the study protocol, the procedures, the
study rules and the safety of participants are our top
priority.
We provide tailored clinical services,
from study design to an ICH integrated study
reports in CTD format. We are flexible and can collaborate
with independents, CROs, laboratories, hospitals and other
organizations as instructed by the sponsor of the study.
Our experts start designing the study and developing the
assay to follow the current regulatory
requirements as applicable. We are able to put in
place a bioequivalence within 2 to 3 weeks. The samples
analysis start within 24 hours after the collection of
last blood sample. The final study report is available
with 3 to 4 weeks.
List
of Validated
analytical methods (OTC and RX Medications).pdf.
If you do not find the analytical method that you are
looking for, contact us about it.
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Samples
processing and storage
©
ALS, all rights reserved. |
3.
Nutraceutical
clinical studies
We started conducting clinical studies of Natural Products and
Functional Foods in 2009. We approach them with the same rigor
and under guidance
as we do with standard clinical trials.
4.
Summary of the clinical
services provided
Project
management implemented for efficiency, processing, tracking
and validating real-time ongoing information available for auditing
and inspections instantly.
-
Study design and Synopsis.
- Study feasibility and Clinical development program and
strategies.
- ICH standard protocols development.
- Integrated protocols.
- Traditional & Electronic Case Report Forms.
- Traditional & Electronic Data Capture (EDC).
- Regulatory approval strategies and electronic submission
(CTD format).
- PK/PD analyses and correlations.
- Various dosage pharmaceutical forms and routes of administration:
- Oral
administration (solid, liquid, suspension, puffs)
-
IV, IM, SC administrations (injection)
and Patches
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Rectal administration
-
Nasal and Ocular
administration
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Topical application with/without medical
devices. |
-
Expert White papers: reports communication, press-release,
feasibility studies,application for grants and funds,
publication of results, etc.
- Pharmacokinetics & Pharmacodynamics of single and
multiple Doses
- Pharmacokinetics of Dose Escalation/Safety and Tolerability
- Relative and Absolute Bioavailability and Bioequivalence
- Pilot and Pivotal Studies
- Fed/Fasted State
- Drug-Drug Interaction.
- Controlled Substances
- Glucose clamp studies
- Multiple Electrocardiograms accessible via intranet
- Multiple-day, 24-hour Urine and Blood collections (steady-state
and safety follow-up). |
ALS package of clinical services includes the claim of the expenditures
submitted to government for the SR&ED program (tax incentives
for R&D activities undertaken in Quebec and Canada) for
eligible clients. |
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