ARTHROLAB

ArthroLab offers a complete range of exclusive services in the field of arthritis and is among the few research organizations with specialized expertise in the design and conduct of osteoarthritis clinical trials. We adhere to Good Clinical Practice standards (GCP). Our staff operates in accordance with Standard Operating Procedures (SOPs) to meet and exceed Canadian, American (FDA) and European (EMEA) regulations.

ArthroLab has well-established experience and expertise in Phase II to Phase IV clinical trials to determine the safety and efficacy of drugs in the treatment of osteoarthritic and rheumatoid arthritic patients and is now one of the largest clinical research units in North America.

Services offered include:

Consultation to determine the feasibility of clinical trials (phase II to IV);

Study design(s);

Protocol development(s);

Preparation of applications for clinical trial approvals (CTA) by health authorities;

Patient recruitments;

Projects monitoring and management;

Biostatistics;

Clinical and statistical study reports; and

Publication in respected journals.

In addition, ArthroVision, a sister company of ArthroLab, has developed and validated a state-of-the-art-technology that has the ability to reliably assess the disease-modifying properties of new potential drugs or biological agents. In 1999, it developed and launched a unique, revolutionary, and patented system (Cartiscope™) that, using magnetic resonance imaging (MRI), provides quantitative evaluation of cartilage volume/thickness over time, thus enabling the determination of osteoarthritis progression. ArthroVision's technology can also provide evaluation of other tissues involved in the disease progression, such as the meniscus, the synovium, the synovial liquid and the subchondral bone. This technology has been successfully used in a number of osteoarthritis clinical trials that assess new disease-modifying drugs (DMOADs) aimed at halting and/or curing this disease. Cartiscope's™ unique high precision (low margin of errors) reduces the time-to-market of new compounds under development.

The unique technology underlying Cartiscope® has revolutionized the field of rheumatic disease and more particularly the osteoarthritis clinical trials. The precision provided by Cartiscope®’s quantitatively-based analysis is currently unmatched.

21CFR Part 11: We work with our suppliers to ensure that all electronically captured data meet the requirements of these regulations.