Canada
Extensive experience in Clinical Research. Medical and clinical monitoring of Phase I-IV clinical trial in oncology, hematology, rheumatology, cardiology, immunology, devices, urology, etc.
Monitoring of clinical investigations, site evaluation and initiation, data collection and quality control review of data collected at trial sites to ensure compliance with protocols, FDA regulations and GCP guidelines for Phase II-IV trials. Review of study data and resolution of queries. Ensuring clinical data quality and completeness, safety review, confirming patient eligibility, protocol compliance, reviewing informed consent forms. Addressing data inconsistencies and clarification with the site staff. Verifying of both individual patient and overall drug accountability, review all appropriate source documents and Investigator Files
Continuous medical oversight for high risk clinical studies (Phase I-III). Collaborates with Clinical Leads and Study Clinicians on study and sites management. Provides training on study protocols to the sites. Performs site feasibility and pre-trial assessment. Reviews protocol non-compliance issues for potential safety/medical implications. Provides support to the clinical team. Visiting clinical sites to resolve medical and safety issues and ensure protocol and GCPs are followed. Reviews SUSAR/SAE reports, etc.
Medical monitoring, medical reviews, Savety surveillance, SAE review/reconciliation, training services.
Reviewing inform consents forms, networking with potential investigators, clinical research site pre-selection, initiation, monitoring and closeout. Management of clinical sites clinical trials in keeping with study protocols, FDA regulations, Company SOPs, and GCP. Drug accountability.
Provided Medical Care to patients with urological disorders. Supervised multidisciplinary medical team. Provided medical and scientific support of ongoing clinical trials.