Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]

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Outsourcing in clinical trial industry has been on the rise for last several decades. This has been due to a combination of several factors, including increasing cost of research, blockbuster molecules going off-patent causing revenue loss and lack of extensive in-house R&D infrastructure. This has resulted in an interesting situation, where increasingly more clinical trials […]

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Recently, the Thailand FDA has brought a revised list of Institutional Review Boards (IRBs)/Ethics Committees (ECs) that it recognizes for acceptance of clinical trial applications. In our previous articles (see Part I and Part II), we’ve discussed the regulatory scenario in Thailand, including regulatory approvals for the clinical trial in Thailand, ethics committee approval for the clinical trial […]

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Investigators, from Brazil who were specialized in Allergy and Immunology segment, were invited to participate in feasibility of a new phase II clinical trial. What’s was the trial about? It’s a phase II – dose selection and confirmatory – clinical trial planned to be conducted in Brazil. What kind of patients were required for this clinical trial? […]

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