Learning about global regulatory requirements and understanding the pathway for approval can help clinical development teams take their global strategy in the right direction. Sharing expertise from regulatory experts for those who need it. (This article was originally published on LinkedIn). It’s no news that we are now living in an era with tremendous surge of […]
Read More →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 […]
Read More →Acute vestibulopathy is characterized by an acute or subacute onset of vertigo, dizziness or imbalance with or without ocular motor, sensory, postural or autonomic symptoms and signs, and can last for seconds to up to several days.1 What is Acute Unilateral Vestibulopathy? Normal vestibular end organs generate an equal resting-firing frequency of the axons, which […]
Read More →Identification and selection of clinical sites and investigator remains one of the first and most important decisions that trial managers take. This also happens to be the one that may define the success (or, failure) of the project. We had been seeing the impact of site / investigator identification on clinical trial successes time and […]
Read More →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 […]
Read More →Trial managers worldwide have been focusing on specific regions for placing their clinical trials. So much so that about 60-70% of clinical trials globally are conducted in USA and Europe alone. However, this is slated to change or should change, if one consults a recent white paper published by Frost & Sullivan. The white paper […]
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