Excellence in Trial Management
COMPANY OVERVIEW Privately held company Founded in 2007 Contract Research Organization HQ in Montréal, Canada Specialized in Clinical Development & Trial Management Client portfolio includes Pharma, Biotech, Generic, Medical Device & CROs
ACCOMPLISHMENTS 2016-20YY Founder and Organizer of Canada Talks Pharma Conference 2016 Excellence in Phase I-IV Clinical Trial Management Services - Canada 2016 Best for Phase I-IV Clinical Trial Management Services Solutions 2015 Nominated by Ernst & Young for Entrepreneur of the Year - Healthcare 2011 Named by PharmaExec Magazine as an Emerging Pharma Leader
LEADERSHIP Vatché Bartekian President & Founder 2015 - Healthcare : Nominated by Ernst & Young for Entrepreneur of the Year 2011- Named by PharmaExec Magazine as an Emerging Pharma Leader Chairperson of Clinical Research Association of Canada (CRAC) Montréal Chapter Advisor to CCTAM (Canadian Clinical Trials Asset Map) Vahé Bartekian Co-Founder & Vice President, Quality Management Viken Bartekian Co-Founder & Vice President, Corporate Development
MEMBERSHIP
VISION SEEING THE FOREST BEYOND THE TREES Life is like a landscape. You live in the midst of it but can describe it only from the vantage point of distance.
BUSINESS MODEL CENTRALIZED GOVERNENCE MODEL Shared values Common objectives Transparency Trust BENEFITS Common goals Streamlined communication Increased clarity Sharing of information Working together for the development of a more effective Strategic roadmap
OPERATIONAL EXCELLENCE CLIENT RELATIONSHIP MANAGEMENT OPERATIONS 3 Pillars of our success QUALITY MANAGEMENT
THERAPEUTIC EXPERIENCE Allergy Cardiology Critical Care Dermatology Diabetes Endocrinology Gastroenterology Generics Immunology Infectious Disease Medical Devices Mental Health Musculoskeletal / Rheumatology Neurology Neutraceuticals Oncology Ophthalmology Osteoporosis Pain Management Pediatric Rare Diseases / Orphan Drugs Respiratory Urology Women s Health
STUDY EXPERIENCE PHASE I BE/BA First in Human Multi Ascending Dose Single Ascending Dose PHASE II-IV Single & Multi Center Interventional/Observational Post Marketing & Safety Surveillance Registry MEDICAL DEVICE Proof of Concept Performance Assessment Diagnostic, Implantable PMA, 510(k), ITA
SERVICES Study Design Feasibility Assessment Protocol Development Case Report Form design Site selection Investigator Meeting Planning Project Management Clinical Monitoring (bilingual) Quality Assurance (GCP/GLP audits) Document Management Vendor Management Regulatory Data Management EDC Services Biostatistical Analysis Medical Writing
STUDY TEAM Audits Partners 3 rd Party Vendors Regulatory Affairs Labs / Bioanalysis EDC / DM Site Management Biostats Clinical Monitoring Project Manager Medical Writing
PROJECT MANAGEMENT Experts in implementing risk mitigation through the use of Quality by Design (QbD) methodologies Oversight of global clinical conduct / site management Project tracking and reviews KPI s Enrollment Ethics submissions / approvals Monitoring visits and reports Milestone Budgets
CLINICAL MONITORING Monitored 350+ Phase 1 Studies THERAPEUTICALLY EXPERIENCED CRA s RISK BASED MONITORING Interpreting the metrics, performance indicators, and trends that emerge from centralized monitoring to ensure proactive decision making and interventions Ensuring continuous flow of study data that is being monitored for trends to enable real-time decision making and action Qualitative reports
SITE MANAGEMENT Responsibilities include: PRO-ACTIVE SITE MANAGEMENT Regular communication with site staff Assessing qualification, training & experience of site personnel Patient recruitment Protocol deviations Drug accountability Data collection & quality
LATE PHASE STUDIES OUR EXPERIENCE ENCOMPASSES ALL LATE PHASE & POST APPROVAL STUDIES WHICH INCLUDE: Registry studies Post market observational studies Meta-Analysis Health Outcomes Research Health Enconomics Research
COMPLEMENTARY SERVICES Site and study rescue with Strategic Working Action Teams (SWAT) SOP development ICH, GCP & GLP Training Functional Service Provider (FSP) Consulting GAP Analysis
SUCCESSFUL STUDIES Phase Oncology Respiratory Generic drugs 12-100 patients Multi-site-country Risk-Based Clinical Monitoring of over 325 clinical studies in multiple therapeutic areas for FDA, Health Canada, EMA Phase Oncology Respiratory Gastroenterology 70-125 patients Multi-site-country FDA, Health Canada Medical Device Diagnostic / Implantable 70 100 patients Multi-site-country 510k, PMA, ITA approvals Phase Phase Respiratory Immunology Diabetes 300-500 patients Multi-site-country FDA, EMA, Health Canada CNS Cardiology Respiratory Rheumatology Dermatology 70-3000 patients Observational, Registry Health Canada, FDA General QA Audits GLP & GCP Audits Investigator Site, hospitals Sponsor CRO s
KEYS TO SUCCESS RISK MITIGATION TRANSPARENCY TEAMWORK ACCOUNTABILITY COMMUNICATION
YOUR AD-VANTAGE QUALITY BY DESIGN STRATEGIES DEDICATED PROJECT TEAM MEDICAL SCIENCE EXPERTISE FINANCIAL & OPERTIONAL FLEXIBILITY TRUST & TRANSPARENCY PROACTIVE SITE MANAGEMENT