Clinical Research Organisations Adding Life to Biotechnology
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1 Clinical Research Organisations Adding Life to Biotechnology An overview by: Venkatraman Sunder Vice-President 1
2 What is CRO? Service provider to biotechnology, pharmaceutical and medical device companies (called as Sponsors) Provide expertise in designing the clinical development program for Sponsors for the conduct of clinical trials to test their product before entering market Facilitate regulatory approval for the product from respective regulatory authorities Providing data and analysis of the product tested to facilitate business development for sponsors Remember many products fail to reach the market for efficacy, safety or toxic nature of product 2
3 Clinical trial phases Pre-clinical - Initially tested on animals Phase I Early use of drug in human Phase II Proof of principle Phase III Larger population Phase IV Post approval & new findings 3
4 Career options in Biotechnology/CRO industry To be part of drug development. Core scientist? Out-standing scientist? To be part of large scale manufacturing To be a regulatory liaison? To be part of clinical development process? To be a CEO/Managing Director? 4
5 Career options in Biotechnology/CRO industry Medical professional supporting clinical research? To be a clinical research professional for trial conduct? To be a data management professional? To be a statistician? SAS programmer? 5
6 What this industry means to individual career? Highly specialized industry Development of core capability must Growing industry Specialized training must Both theory and practical, essential for successful job pitching 6
7 Positions and qualifications Scientist Graduate/Post Graduate in science with special focus on Microbiology, Biotechnology, Pharmacy with further advancement as Ph. D Medical Professionals MBBS/MD with specialization in Pharmacology, Internal medicine IT professionals Graduate/Post Graduate in IT with focused training on database development and data processing Bio-statistics Post Graduate/Ph. D in Statistics with capability to analyze complex data 7
8 Income range (annualized) India (depending on city) in Rupees Junior Scientists Starting120 to 200k Senior scientists upwards 250k Medical professionals upwards 250k Clinical research professionals Starting 150k IT/Data management Starting 150k Statisticians Starting 200k USA/Europe/ Australia/Canada in $/Euro Start up scientists in universities 30 to 40k Senior scientists 60 to 100k MD Startup 75k Clinical research professionals startup 50k IT/Data management startup 50k Statisticians startup 60k For experienced and proven sky is the limit 8
9 Career drivers Strong basic fundamentals Creative mind and approach Eye for innovation Urge to grow Understanding tools Knowledge of computers 9
10 Job profiles Scientists Clinical Research Associates Clinical Data management associates Biostatisticians/SAS programmers Medical professionals Regulatory specialists Project Managers Data Managers Safety Managers Regulatory Liaison Business Development Managers 10
11 Training Academy for Clinical Excellence, Mumbai ( Institute of Clinical Research (India), Delhi/Mumbai/Bangalore/Ah bad ( Bioinformatics Institute of India, Noida ( Many universities and start up private institutions 11
12 Other information resources Drug Information Associates ( Center for Drug Evaluation and Research (CDER) ( Center for Biologics Evaluation and Research (CBER) ( Center Watch ( ICH ( (Major information base and guidelines) Institute of Clinical Research (formerly ACRPI) ( Society for Clinical Data Management ( Clinical Trials Info ( Central Drugs Standard Control Organization (CDSCO), Govt. of India ( 12
13 Venkatraman Sunder Presentation Powered by: 13
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