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BE guidelines regarding investigator

BE guidelines recommend investigator should possess appropriate medical qualification, experience for conducting pharmacokinetic studies Can chairperson of EC directly write to sponsor to clarify some of the queries of clinical trial raised in EC meeting? Dr. Sreevatsa Please see an extract from FDA's comment on IRB-sponsor relationship. The interrelationship and interaction between the research sponsor (e.g., drug, biologic and device manufacturers), the clinical investigator and the Institutional Review Board (IRB) may be very complex. The regulations do not prohibit direct sponsor-IRB contacts, although, the sponsor-IRB interaction customarily occurs through the investigator who conducts the clinical study. The clinical investigator generally provides the communication link between the IRB and the sponsor. Such linkage is agreed to by the sponsors and investigators when they sign forms FDA-1571 and FDA-1572, respectively, for drug and biologic studies or a...
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Combination Vaccine for Kids withdrawn

A vaccine that combines conventional MMR (Measles, Mumps, Rubella) with Chikenpox has been withdrawn in the United States due to a higher rate of seizures in children. In a study children aged 12 to 23 months who received the combined MMR cum Chickenpox vaccine had double the rate of seizures compared to children who got separate vaccine for MMR and chickenpox. This equates to one additional case of convulsion per 2000 vaccinations.
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India Contract Research Organization Market, is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022

Market Research Future published a Statistic research report on India Contract Research Organization Market, from 2017 to 2022″ – Market Analysis, Scope, Stake, Progress, Trends and Forecast to 2023. ​ India Contract Research Organization Market, is projected to grow at a CAGR of 20.4% and is expected to reach US$ 6,310.5 million by 2022. In India contract research organization market, drug development/clinical trials accounted for the largest market share in 2016. A Contract Research Organization (CRO) is a service association that offers help to the pharmaceutical business and offers an extensive variety of outsourced pharmaceutical research administrations to help in R&D system and in this way a basic tool for undertaking clinical trials in the present situation when high stakes are included in the drug discovery process. This industry likewise offers a safe choice of venture as the business is to a great extent recession-proof, with a critical upscale development. Get a sample ...
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