Excellence in Trial Management

Transcription

1 Excellence in Trial Management

2 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

3 ACCOMPLISHMENTS YY 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

4 LEADERSHIP Vatché Bartekian President & Founder Healthcare : Nominated by Ernst & Young for Entrepreneur of the Year 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

5 MEMBERSHIP

6 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.

7 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

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

9 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

10 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

11 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

12 STUDY TEAM Audits Partners 3 rd Party Vendors Regulatory Affairs Labs / Bioanalysis EDC / DM Site Management Biostats Clinical Monitoring Project Manager Medical Writing

13 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

14 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

15 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

16 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

17 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

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

19 KEYS TO SUCCESS RISK MITIGATION TRANSPARENCY TEAMWORK ACCOUNTABILITY COMMUNICATION

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