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Premium member Presentation Transcript GENELIFE CLINICAL RESEARCH : GENELIFE CLINICAL RESEARCH Genelife Clinical Research : Genelife Clinical Research is the initiative to provide quality clinical research services with high recruitment rate with quality data . Core offerings include Regulatory Submissions & Consulting, Preclinical Studies, BA/BE, Clinical Project Management (Phase II to IV), Clinical Data Management, Bio-Statistics and Medical Writing Genelife is a CRO that provides Product development & support services to global Medical Device, Pharma, and Biotech players with experienced team of more than 20 years. The primary objective of the company is to provide quality service to the Pharmaceutical & Biotechnological companies involved in Product Discovery and Development in a cost and time effective manner. www.genelifecr.com Genelife Clinical Research Slide 3: www.genelifecr.com Genelife Clinical Research- Synopsis Consulting Clinical Trials (Phase II-IV) Data Management Bio Statistics Medical Writing Other Services GAP analysis Feasibility Analytical Development & Validation Formulation Development Study Feasibility Analysis Investigator / Site Selection Regulatory Submission Initiation/Training Visits Site Management & Monitoring IP Management Closeouts Query Resolution Database Design Database Validation Data Entry & Tracking Data Coding Database Access Management Data Management Reporting Risk & Query management Clinical Trial Design Sample Size Calculation Statistical Analysis Plans Planning & Execution of interim analysis Final Statistical Analysis Statistical Report Study Design/ Outline Protocol & its Amendments Informed Consent Document Patient Diary and Subject Emergency Card Clinical / Statistical study Report Publication Support SAE collection, evaluation, classification & reporting Medical case reviews Adverse event narration & coding Pharmacovigilanc BA/BE studies Biochemical Assays Preclinical Services www.genelifecr.com LOCATION : LOCATION Genelife Clinical Research Office Number 33, 34, 35 Ground Floor CinewonderMall Kapurbawdi Ghodbundar Road Thane West-400607 Maharashtra India Organizational Chart : Organizational Chart MD Finance Manager QA Manager Pharmacologist Regulatory Affairs CDM BD Head Accounts/ Admin ClinOps Head Project Manager CTL CRA CRA Project Assistant Data Associate Data Associate Data QA Manager BDM Program Manager Medical Writer Consultant www.genelifecr.com GCP Compliance Certificate : www.genelifecr.com GCP Compliance Certificate US-FDA Compliance Certificate : US-FDA Compliance Certificate Regulatory Affairs : Regulatory Affairs Regulatory Submissions in and outside India Regulatory Dossier Compilation Periodic Safety Updates Reports Genelife CR- Non-Clinical Services : Genelife CR- Non-Clinical Services Toxicology Services Efficacy Studies Safety Pharmacology Stability Studies Genelife CR- BA/BE Service : Genelife CR- BA/BE Service Genelife, through preferred partners can perform: Housing Experimental Analysis/bioanalysis Quality Assurance Medical Writing Project Management Data Management & Biostatistics Genelife CR-Clinical End-Point Study : Genelife CR-Clinical End-Point Study Genelife can execute clinical end point studies in following service categories: Medical Writing Regulatory Submissions and Approvals Project Planning and Management Clinical Trial execution Vendor Management Data Management and Analysis Quality Assurance Pharmacovigilance Clinical End-Point Study : Clinical End-Point Study Genelife CR is currently executing following Clinical End Point Projects in India: Randomized Multinational Three arm study in Gastroenterology Randomized Multinational Three arm study in local application for Dermatology Projects in Pipeline Randomized Multinational Three arm study in local application for Dermatology Randomized Multinational study in Post Trauma Stress Disorder Randomized Multinational study in Weight Reduction Slide 13: Work Flow of Clinical Operations Genelife Initiatives : Genelife Initiatives Disease Surveillance Report Genelife has conducted a survey in different healthcare institutes across India. Focus of Surveillance was to get an insight into different disease and condition prevalence in different parts of India. The Report is an exhaustive compilation of disease with sub categories and its prevalence with respect to age and gender. Genelife Initiatives-DSR : Genelife Initiatives-DSR Why Genelife? : Why Genelife? We are a CRO providing end to end service for Drug Development. Have a database of Disease Surveillance Report (DSR) Employee Experience of more than 50 years Being a new CRO, our focus is building trust and this makes Genelife CR an economical option with quality output Contact us at: : Contact us at: firstname.lastname@example.org Telefax: +91-22-65242666 www.genelifecr.com Genelife Clinical Research Slide 19: Thank You You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.