Phase 1 Clinical unit located in Toronto, Ontario, Canada with 180 clinical beds.
Full-service CRO from study design inception to clinical trial execution. Data reporting and tabulation to the final Clinical Study Report including CDISC compliant.
Key areas of focus include Phase I clinical studies, PK/PD, Human Abuse Potential and Abuse Deterrent Assessments, BE/BA for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and depot injections), controlled-substances, DDI, FIH, SAD/MAD, Special populations, Medical Cannabis, First-to-File ANDA submissions to the US FDA.
State of the art Bioanalytical Laboratory using LCMS/MS for Method Feasibility, Development & Validation, Biological sample analysis for BE/BA/Clinical studies and Bioanalytical support for nonclinical toxicokinetics.
Successfully audited by US FDA, Health Canada, EMA (ANSM & DKMA) WHO, ANVISA and the standard Council of Canada.
Keyrus Life Science Canada
Keyrus Life Science (KLS) is THE connected CRO having great experience with clinical trials in Phase I to IV in many different therapeutic areas.
With more than 300 employees, KLS is a leader in the management and auditing of clinical trials since 1998 including Europe, India and North America.
Impressive and successful track record with more than 250 clinical trials, 10000 sites and 100000 patients.
Monitoring of more than 400 PK studies, BE, SAD, MAD, PoC, DDI and all dosage form administrations.
Experience with studies involving FDA/TPD/ANVISA/EMA.
Med-Script Associates Ltd.
Specializing in pharmaceutical Regulatory Affairs and services in Research and Development for 25yrs+
Pharma Medica Research Inc (PMRI) is a science driven Contract Research Organization offering full-service solutions for early phase clinical trials.
Our GCP-compliant custom designed and built clinical unit is at the core of our operation. Our 115,000 square foot facility houses 360 beds divided into 6 independent clinics which is the ideal infrastructure for large studies, long-term confinement and offer the maximum flexibility.
Our state-of-the-art, 65,000 square foot GLP-certified bioanalytical lab offers 24 LC/MS/MS instruments and in-house organic lab for synthesis of stable isotope internal standards & metabolites offering unmatched quality.
QbD method development, validation, and sample analysis from all stages of your clinical trials (pre-clinical to Phase IV) allowing a consistent method through the full product life cycle.
Presenting innovative study designs, scientific medical writing, biostatistical analysis, biometrics, clinical data management with CDISC compliance and the final CSR tailored for the targeted jurisdiction.
Experience conducting over 5,000 studies for submission to regulatory agencies around the world.
Extensive experience throughout all clinical trial stages and across multiple therapeutic areas for New Chemical Entities (NCEs) / New Therapeutic Entities (NTEs), hybrid submissions (505b2 and Value-Added Medicine) and generic submissions (ANDA).
Since 1997 we have been successfully audited by USFDA, EMA, MHRA, AEMPS, LVSAM, AGES, Health Canada, ANVISA, World Health Organization (WHO), Standard Council of Canada and approved BE Center by Gulf Cooperative Council offering a strong track record.
Royalmount Laboratories
FDA & TPD approved Bioanalytical GLP laboratory operating since 1994.
300K samples analyzed/year.
Real-time LIMS for fastest most reliable data possible.
