Atlantic Life Sciences, Inc.
                         



             
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We do only what we know very well. ALS, the partner for your drug products development!

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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