Pharma Medica Research Inc.

Pharma Medica Research Inc. is a full-service Contract Research Organization (CRO) in Canada, offering clinical research and bioanalytical services to sponsors.

Clinical services

• Experience across a broad range of clinical trials evaluating safety, efficacy, and quality of medical treatments across therapeutic areas.
• Design and execution of well-controlled trials, including data collection and analysis.
• A 24-hospital bed Phase I Unit with automated data capture.

Bioanalytical services

• A Laboratory Data Management System (LDMS) developed and validated in-house to capture analytical activities from sample accession to reported results, with full audit trail capabilities and FDA 21 CFR Part 11 compliance.
• A bioanalytical team that works to internal SOPs and global regulatory requirements.
• The company is a Topic Leader for ICH M10 and participates in the Global CRO Council (GCC).

Scientific affairs

• Clinical trial design, clinical protocol development, and clinical study report finalization.
• Pharmacokinetic scientists, clinical pharmacologists, biostatisticians, SAS programmers, and clinical data managers.
• Experience with New Chemical Entities, Hybrid/Value Added Medicine/505(b)(2), and generic formulations.

Quality

The company states that its Quality Management System supports a track record of passing regulatory inspections and Sponsor audits, and it integrates automated data capture and data assurance across clinical and laboratory stages.