SLIDE 1
Excellence in Trial Management COMPANY OVERVIEW Privately held - - PowerPoint PPT Presentation
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 Montral, Canada Specialized in Clinical Development & Trial Management Client portfolio includes Pharma,
SLIDE 2
SLIDE 3
ACCOMPLISHMENTS
2011 | Named by PharmaExec Magazine as an Emerging Pharma Leader 2015 | Nominated by Ernst & Young for Entrepreneur of the Year - Healthcare 2016 | Best for Phase I-IV Clinical Trial Management Services Solutions 2016 | Excellence in Phase I-IV Clinical Trial Management Services - Canada 2016-20YY | Founder and Organizer of Canada Talks Pharma Conference
SLIDE 4
LEADERSHIP
Viken Bartekian Vahé Bartekian Vatché Bartekian
President & Founder
2015 - Healthcare : Nominated by Ernst & Young for Entrepreneur
- f 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 Co-Founder & Vice President, Corporate Development
SLIDE 5
MEMBERSHIP
SLIDE 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.”
SLIDE 7
BUSINESS MODEL
Working together for the development of a more effective Strategic roadmap
Shared values Common objectives Trust Transparency CENTRALIZED GOVERNENCE MODEL BENEFITS Common goals Streamlined communication Sharing of information Increased clarity
SLIDE 8
OPERATIONAL EXCELLENCE
CLIENT RELATIONSHIP MANAGEMENT QUALITY MANAGEMENT OPERATIONS
3
Pillars of
- ur success
SLIDE 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
SLIDE 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
SLIDE 11
SERVICES
Regulatory Data Management EDC Services Biostatistical Analysis Medical Writing Quality Assurance (GCP/GLP audits) Document Management Vendor Management Study Design Feasibility Assessment Protocol Development Case Report Form design Site selection Investigator Meeting Planning Project Management Clinical Monitoring (bilingual)
SLIDE 12
STUDY TEAM
Project Manager
Clinical Monitoring Site Management Labs / Bioanalysis Audits Partners 3rd Party Vendors Regulatory Affairs EDC / DM Biostats Medical Writing
SLIDE 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
SLIDE 14
CLINICAL 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
Monitored ed 350+ Phase 1 1 Studies THERAPEUTICALLY EXPERIENCED CRA’s
RISK BASED MONITORING
SLIDE 15
SITE MANAGEMENT
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
Responsibilities include:
SLIDE 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
SLIDE 17
COMPLEMENTARY SERVICES
Functional Service Provider (FSP) Site and study rescue with Strategic Working Action Teams (SWAT) SOP development ICH, GCP & GLP Training Consulting GAP Analysis
SLIDE 18
SUCCESSFUL STUDIES
Phase 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
Oncology | Respiratory | Gastroenterology
- 70-125 patients
- Multi-site-country
- FDA, Health Canada
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
Diagnostic / Implantable
- 70 – 100 patients
- Multi-site-country
- 510k, PMA, ITA approvals
General Medical Device
QA Audits
- GLP & GCP Audits
- Investigator Site, hospitals
- Sponsor
- CRO’s
SLIDE 19
KEYS TO SUCCESS RISK MITIGATION
ACCOUNTABILITY
TRANSPARENCY
COMMUNICATION
TEAMWORK
SLIDE 20