Important industry news and company updates
Digitalization of clinical trials: What does the future hold?
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Published - 13.Mar.2015

  New horizons for health care are being unveiled thanks to the progressive mobile technologies. Digitalization of clinical trials is becoming more and more commonly known as the use of mobile and wireless gadgets is proved to support the achievements of different Pharmaceutical companies. Undoubtedly, mHealth(Mobile Health) holds immense potential and importance which the Pharma sector is beginning to realize. Technologies turn into a virtual goldmine for this particular industry because they have the required capacity to serve in a way...MORE >

Changes in the GMP Regulations – Overview
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Published - 10.Mar.2015

Good Manufacturing Practice Drug quality affects everyone involved in Clinical Research in one way or another. Undoubtedly, consumers expect that the pharmaceutical medicaments which they take will meet all necessary quality standards and requirements so that the use of medicines is not only effective but safe too. However, not everyone is well aware and well informed in terms of what Good Manufacturing Practice is and what its enforced regulations actually do. Accordingly, GMP serves to make sure that proper design,...MORE >

Medical Writing: Goals, Benefits and Requirements
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Published - 27.Feb.2015

Medical Writing and its Fundamentals The medical field is rapidly developing and an extensive flow of information as well as knowledge is circulating around and is constantly being added to the sector. The increasing number of research studies that brings on new data, ideas, thoughts and perceptions needs to be systematized and depictured in the most appropriate manner. The demand for a clear articulation of a complex aggregation of facts and discoveries becomes a key factor which reflects on the understanding...MORE >

Effective Risk-Based Quality Management Grants Effective Results
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Published - 24.Feb.2015

Although FDA regulations for the pharmaceutical industry have not altered that much for the last 30 years, expectations for a risk-based quality management are growing and shifting. The well-known set of ethical and scientific standards, provided by ICH and known as Good Clinical Practice, for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials resides in the foundation of every organization in this sector. But what exactly draws a link between GCP and Risk-Based Quality Management?...MORE >

Good Clinical Practice: From the Ground up
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Published - 17.Feb.2015

Any professional in the Pharma and Clinical Research Industry should be aware of what GCP stands for, as it has now become an integral part of the business model of all big organisations in this sector. Good Clinical Practice (GCP) is internationally recognized set of ethical and scientific standards, provided by ICH, for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies. Its purpose is to protect the rights, safety and welfare of people...MORE >

Big Data – Importance, Characteristics and Trends
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Published - 12.Feb.2015

Big data is a term that is in a constant process of becoming more and more popular and important to all kinds of business sectors and industries in the last couple of years, especially in the Clinical Trials and Pharma, as any trials keeps close track of large amounts of data, in terms of results, documentation, etc. The term is used to describe a huge volume of data that is both structured and unstructured. Usually, such overflow of information is...MORE >

Online Education, Academic Progress, Improving Life Sciences Globally!
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Published - 06.Feb.2015

Online trainings and education are beneficial not only to students but to company employees as well. When companies want to keep their staff updated and aware of the latest products or procedures, such educational and informative methods become the best possible choice especially in the fast-developing Pharma industry. Our team at Astra Nova has established the Better Industry Initiative (Bii) which offers free of charge quality online training for individuals, as well as different academic and private organisations. The implementation...MORE >

The European Medicines Agency (EMA) public consultation on application of new transparency regulations
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Published - 03.Feb.2015

The European Medicines Agency (EMA) has launched a public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database. The foundation of the EMA’s scientific perceptions is based on the outcomes of clinical trials implemented by different pharmaceutical companies. On the 1st of January, 2015, the Agency introduced a new policy which required publishing of clinical data. The main goal is to achieve sufficient transparency of clinical researches by providing details to...MORE >

The Clinical Trials Transparency Dilemma
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Published - 27.Jan.2015

The progress of clinical trials and the major advances in the Pharma industry would be hard to achieve without volunteers who decide to take part in a number of medical studies. Yet, one of the most debated topics in this sphere is the one related to the clinical trials transparency. In other words, the question is whether or not there should be a much richer and informative scope of data revealed to the public in order to clarify and contribute...MORE >

Do not just spend your annual budget leftover. Invest it!
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Published - 20.Jan.2015

Every company prepares a specific budget for a 12-month period. Such annual budget indicates different incomes and expenditures which are planned to be received and, respectively, spent throughout the upcoming year. Nevertheless, there is money which is still preserved by the end of the same year. Being too careful not to spend all of the resources in the first months, managers are faced with the problem of how to properly use the leftover amount at the end of the given...MORE >

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