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Atlantic Life Sciences is an industry leading CRO
in the early stage clinical research development services. Our 20
years of experience with studies clinical conduct and our deep knowledge
of guidance allow 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. All our clinical studies pass the regulatory
review successfully.
1.
Phase
0 / First-in-man and
Phase
I clinical studies
ALS Inc. has a
GCP pharmacology unit is 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
of First-in-man
and Phase 1 clinical studies
as written and to record the data clearly.
In our understanding this is a criterion for the quality of
clinical conduct and the safety of participants. 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 drug products)
ALS has a-recently
renovated,
smoke-free overnight inpatient
facility.
It allows controlling the criterion of light-smoker when they
allowed to participate.
Our expertise of phase 1 clinical trials is an asset for bioequivalence
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 of the FDA, TPD, EMEA, and ANISA.We
are able to put in place a bioequivalence within 2 to 3 weeks.
The samples analysis start with 24 hours after the collection
of last blood sample. The final study report is available with
3 to 4 weeks.
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.
Clinical
services
Project
management implemented for efficiency, processing, tracking
and validating real-time ongoing information available for auditing
and inspections instantly.
We do only what
we know very well, we are able to evaluate the study protocols
as they manifest in real-life and therefore able to hit the
milestones and the deadlines.
-
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
-
Rectal
administration
-
Nasal
and Ocular administration
-
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
- Pharmacokinetis 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). |
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.
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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