Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 2, Issue 1, 2015

Clinical care is provided in a team approach because each member of the inter-professional team has valuable input to contribute to the care of patients. Clinical research is no different in that the construction of a research study is stronger if the right contributors are involved in the development stages. Having a peer-driven facilitative review process in place allows for proposed clinical research studies to be reviewe Read More

Background: Intensive versus less stringent glucose control does not confer significant benefits in critical illness. However, insulin may have beneficial effects apart from its role in glucose homeostasis. Methods: Pilot, open-label, non-randomized study of glucose-insulin-potassium (GIK) infusion versus saline placebo in vasopressor dependent septic shock designed to test feasibility, safety, and preliminary efficacy. Inflam Read More

The globalization of medical training has evolved in various ways including individual student migration across borders, academic institutional expansion abroad and governmental influence. The drive for revenue and the balance with teaching excellence is a struggle that medical institutions increasingly contend with today as they navigate in a global environment. In this review, we focus on this emerging data, spe Read More

In medical education, examples of global collaborations or partnerships are plentiful, as are the multifactorial motivations driving them. The outcome of transported educational models outside their original target environment can be difficult to predict, however, as contexts, cultures, norms, histories, traditions, processes, and practices coalesce among diverse groups. The resultant diversity can be considered a doubl Read More

In spite of the after-effects of the global economic depression in the past few years, the direction of drug research in Finland is clear and positive. The industry is growing at a pace greater than the economic indices. Nordic collaboration has a significant influence on drug research and development in Finland. Recent statistics by the Finnish Medicines Agency (FIMEA), which supervises drug research and development indi Read More

Is your facility inspection ready at all times? Most organization are not ready at all times and, therefore find preparing for any type of FDA Inspection to be overwhelming. This paper provides guidance on how to prepare and how to respond to the FDA, specifically for larger clinical site inspections, Clinical Investigators, and drug manufacturer inspections. Also, tips are provided on how to take a proactive inspection readi Read More

The Clinical Research industry has been in a state of dilemma with the changing regulatory scenario of India. It started with an upsurge of projects between 2005 and 2010 and then a steady decline in the last 5 years. The Government has reacted to this paradigm shift by instituting new regulations with more stringent measures to check compliance and conduct of the clinical research activities. The prime area of focus h Read More

Transient abnormal myelopoiesis is a unique syndrome characterized by leukocytosis with transient appearance of blast cells in the peripheral blood and bone marrow. Children with Down syndrome are at a higher risk of developing the disease as compared to normal children. Affected patients can be symptomatic or asymptomatic. We report a case of a male infant, born to a mother with history of infertility, who was found to h Read More