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Want to SAVE a Few Million Dollars?. Give Us the OPPORTUNITY Do Just That and Well.

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Presentation on theme: "Want to SAVE a Few Million Dollars?. Give Us the OPPORTUNITY Do Just That and Well."— Presentation transcript:

1 Want to SAVE a Few Million Dollars?

2 Give Us the OPPORTUNITY Do Just That and Well

3

4 Delivering Exceptional Clinical Trial Performance A CRO

5 InClin delivers exceptional clinical trial performance On Time On Budget With personalized, high-quality service For more than 96 sponsor companies On more than 247 trials In more than 40 Countries Including 50 pivotal Phase 2 and Phase 3 studies With a 95% on-time or early performance record in Phase 2 – 3 studies What InClin Does

6 Consulting and CRO Services Major Clinical Programs Completed InClins Performance Phase 1 Phase 2 Phase 3 Antiviral: 1999 NDA – Flu Anti-Infective: 2006 NDA – Oesophageal Candidiasis Pain Management: 2008 NDA – Dental Anesthesia Reversal Primary Immune Deficiency: 2011 BLA – SC Cardiovascular: 2008 NDA Bioequivalence Anti-Infective: 2010 NDA – cSSSI + CABP Primary Immune Deficiency: 2005 BLA – IV Anti-Infective: 2007 NDA – cUTI + cIAI Anti-Infective: 2008 EMA and Canadian Approval – Nosicomial Pneumonia (HAP and VAP) Cardiovascular: 2010 sNDA Bioequivalence

7 InClins Performance Over 14 Years

8 Core Expertise Planning Conducting clinical trials Managing Clinical Trials

9 Project Management Project Management Clinical Monitoring Clinical Monitoring Data Management Data Management Biostatics Biostatics Medical Writing Medical Writing Clinical Research Consulting Clinical Research Consulting CRO Services

10 Consulting Services Senior Quality Assurance GxP Auditing Clinical Program Planning Protocol and Medical Writing Regulatory Affairs High Performance Project Teams

11 Our Company

12 Who We Are A premier North American Clinical Research Organization (CRO) Provide Phase 1 – 4 clinical research services to the pharmaceutical, biotechnology & medical device industries

13 Phase 1 – 3 Experience Proof-of-Concept With PK, biomarker & imaging requirements Global Studies Pharmacoeconomic Studies Class I-III: 510(K) Extension/Marketing trials 3 Phase First in man, SAD, MAD, with extensive PK and biomarker requirements, TX populations Special Population, TET studies Phase2 1

14 Diverse Therapeutic Experience Cardiovascular Class III Devices CNS Dermatology Gastroenterology Hematology Immunology/Immune Deficiency Infectious Disease Antibiotic/Antifungal/Antiviral Metabolic Bone Disease/ Endocrinology Oncology Ophthalmology Pain/Pain Management Pulmonary Diseases Seasonal Illnesses

15 Main Therapeutic Areas

16 Experience by Segment

17 InClin has delivered exceptional global clinical trial performance in more than 40 countries North America South America WEU EEU Asia South Africa Australia

18 The Foundation of Success: People and Methodologies

19 Project Success! Our staff retention rate is 95% The team you start with is the team you end with Highly experienced and highly trained The InClin Team

20 Functional GroupStaff Average Years Experience Average Global Trial Experience Senior Management Team years Clinical Project Managers years CRAs and Regional CRAs years CTAs years Regulatory Specialists years The InClin Team

21 Drug safety monitoring and reporting Medical monitoring Data management and biostatistics These Partnerships are based on: Synergy with our people and our methodologies Strong performance records Qualified vendor status These Include: Integrated Partnerships For select functions, InClin partners with quality organizations that share our key values

22 Strong Quality Framework Expert Project Management Proven Processes Our Methodologies

23 InClin Quality Framework Regulated Activities Non-Regulated Activities Policies Methodologies Clinical Operations Procedures Plans, manuals, project tools Training Materials Function-Specific SOPS Cross-Functional SOPS

24 SOPs provide standardized processes for all services Proven tools and methodologies On-going project oversight by the InClin executive management team We provide our experienced project teams with a strong organizational structure and integrated framework Independent Quality Unit oversight of each project Quality is built-in to our methodologies Methodologies InClin Quality Framework

25 Our Quality Record 2 Pre-Approval Inspections (PAIs) 30+ FDA Site Audits 7 New Products Approved InClin-managed studies and sites have undergone multiple regulatory audits

26 Each directly impacts quality. They are totally interrelated – if one is impacted it impacts the others. Our project management methodology focuses on three key project variables InClins success comes from our ability to manage them all effectively. Time (Schedule) P e o p l e & $ $ ( B u d g e t ) Customer Requirements (Scope) Quality Expert Project Management Core Methodology

27 Integrated Clinical Operations Approach Strong Planning and Project Management Strong Teams Effective Communication High-Quality Monitoring and Data Review Strong Vendor Management Our Methodologies Focus on the Basics

28 InClin delivers exceptional clinical trial performance On Time On Budget With personalized, high-quality service For more than 96 sponsor companies On more than 247 trials Including 50 pivotal Phase 2 and Phase 3 studies With a 95% on-time or early performance record in Phase 2 – 3 studies What InClin Does

29 © 2011 InClin, All Rights Reserved.


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