David Barkhimer's Contact Details

David Barkhimer's Company Details

Canyon Ridge Consulting, LLC specializes in contract Medical Writing, Clinical Trials Management and Project Management.MEDICAL WRITING, DOCUMENT PREPARATION, AND REVIEW - extensive experience with creation and preparation of Investigational New Drug Applications (US, Canada, and UK), New Drug Applications (US and Canada) and Marketing Authorization Applications (EMA), orphan drug applications, clinical study reports, protocols and amendments, informed consent templates, case report form design, monitoring conventions and CRF completion instructions, data edit checks, blinded and unblinded data listing reviews, patient narratives, abstracts, SOPs, preparation of external training and presentation materials, quality control review of protocols, and investigator brochures;PROJECT/TRIAL MANAGEMENT, TEAM AND CRO OVERSIGHT, AND VENDOR MANAGEMENT - create and manage clinical development master project plans; perform training and supervision of sponsor and CRO employees and contractors in monitoring procedures; liaison between sponsors, vendors, and site staff; review visit reports from sponsor and CRO staff; manage investigational product; oversee central laboratory results; assess vendor performance; perform audits of Trial Master Files; perform pre-audit inspections of sites/data;VENDOR AND SITE SELECTION, MANAGEMENT, AND STAFF TRAINING - preparation of requests for proposals; evaluation of proposals (including detailed budget analysis and comparison) and selection of vendors (CRO, pharmacovigilance, central laboratory, specialty nursing, etc.); selection of investigational sites; negotiation of investigator budgets; review and approval of site contract payments; in-depth knowledge of FDA, ICH, and GCP requirements; protocol-specific procedures and CRF completion; presentations at Investigator Meetings; EDC CRF case monitoring; regulatory document review; data query resolution with sites and data management personnel.