Excellence in Trial Management COMPANY OVERVIEW Privately held - PowerPoint PPT Presentation

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 President & Founder Vatché Bartekian 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) Co-Founder & Vice President, Quality Management Vahé Bartekian 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 BENEFITS GOVERNENCE MODEL Common goals Shared values Streamlined communication Common objectives Transparency Increased clarity Sharing of information Trust Working together for the development of a more effective Strategic roadmap

OPERATIONAL EXCELLENCE CLIENT RELATIONSHIP MANAGEMENT 3 Pillars of our success QUALITY OPERATIONS MANAGEMENT

THERAPEUTIC EXPERIENCE Allergy Musculoskeletal / Rheumatology Cardiology Neurology Critical Care Neutraceuticals Dermatology Oncology Diabetes Ophthalmology Endocrinology Osteoporosis Gastroenterology Pain Management Generics Pediatric Immunology Rare Diseases / Orphan Drugs Infectious Disease Respiratory Medical Devices Urology Mental Health Women’s Health

STUDY EXPERIENCE PHASE I PHASE II-IV MEDICAL DEVICE BE/BA Single & Multi Center Proof of Concept First in Human Interventional/Observational Performance Assessment Multi Ascending Dose Diagnostic, Implantable Post Marketing & Safety Single Ascending Dose Surveillance PMA, 510(k), ITA Registry

SERVICES Quality Assurance (GCP/GLP audits) Study Design Document Management Feasibility Assessment Vendor Management Protocol Development Case Report Form design Site selection Investigator Meeting Planning Project Management Regulatory Clinical Monitoring (bilingual) Data Management EDC Services Biostatistical Analysis Medical Writing

STUDY TEAM Partners 3 rd Party Regulatory Vendors Audits Affairs Labs / EDC / DM Bioanalysis Site Biostats Management Project Clinical Medical Manager Monitoring 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 ed 350+ Phase 1 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 SOP development Site and study rescue with Strategic Working Action Teams (SWAT) ICH, GCP & GLP Training Consulting Functional Service Provider (FSP) GAP Analysis

SUCCESSFUL STUDIES Oncology | Respiratory | Generic drugs Phase • 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 • Diagnostic / Implantable Multi-site-country Medical • • 70 – 100 patients FDA, Health Canada • Device • Multi-site-country • 510k, PMA, ITA approvals Phase Respiratory | Immunology | Diabetes • 300 - 500 patients QA Audits • Multi-site-country GLP & GCP Audits • • FDA, EMA, Health Canada Investigator Site, hospitals General • Sponsor • CRO’s • Phase CNS | Cardiology | Respiratory | Rheumatology | Dermatology • 70 - 3000 patients • Observational, Registry • Health Canada, FDA

KEYS TO SUCCESS TRANSPARENCY RISK MITIGATION TEAMWORK ACCOUNTABILITY COMMUNICATION

YOUR AD-VANTAGE QUALITY BY DEDICATED DESIGN PROJECT TEAM STRATEGIES FINANCIAL & MEDICAL SCIENCE OPERTIONAL EXPERTISE FLEXIBILITY TRUST & PROACTIVE SITE TRANSPARENCY MANAGEMENT