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Published byJamison Combes Modified over 10 years ago
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Want to SAVE a Few Million Dollars?
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Give Us the OPPORTUNITY Do Just That and Well
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Delivering Exceptional Clinical Trial Performance A CRO
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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
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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
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InClins Performance Over 14 Years
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Core Expertise Planning Conducting clinical trials Managing Clinical Trials
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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
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Consulting Services Senior Quality Assurance GxP Auditing Clinical Program Planning Protocol and Medical Writing Regulatory Affairs High Performance Project Teams
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Our Company
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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
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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
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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
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Main Therapeutic Areas
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Experience by Segment
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InClin has delivered exceptional global clinical trial performance in more than 40 countries North America South America WEU EEU Asia South Africa Australia
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The Foundation of Success: People and Methodologies
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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
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Functional GroupStaff Average Years Experience Average Global Trial Experience Senior Management Team520+15+ years Clinical Project Managers1610+7+ years CRAs and Regional CRAs757+3 + years CTAs53+5 + years Regulatory Specialists27+5 + years The InClin Team
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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
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Strong Quality Framework Expert Project Management Proven Processes Our Methodologies
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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
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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
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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
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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
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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
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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
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© 2011 InClin, All Rights Reserved.
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