Important industry news and company updates
Clinical Trials Transparency pt.2 – Aims and Obstacles
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Published - 31.Jul.2015

Clinical trials transparency is among the hottest and most discussed topics which circulate around the Pharmaceutical, Medical and Clinical world. Even though it is considered to work in the best interest of clinical trial participants, the truth is in fact, quite different. This is so not because the easy accessible database reveals information which may jeopardize clients’ confidentiality, for example. It is rather because in some cases there is pivotal data about clinical trials results which is actually missing. What...MORE >

Good Storage Practice: Definition, Risks and Proper Implementation
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Published - 21.Jul.2015

Good Storage Practices (GSPs) play an integral role in various Pharmaceutical and Pharmacovigilance-oriented companies, organizations and institutions. Each one of them is required to demonstrate not only efficient management but also efficient storage of pharmaceutical products. Such efficient storage of drugs is essential because it will that the potency and the physical integrity of medicaments are preserved and kept. What is more, GSPs are activities which generally prevent deterioration and ensure that the quality and safety of drugs are also...MORE >

Clinical trials transparency issues: the other side of the coin
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Published - 14.Jul.2015

Clinical trials transparency is understood to be part of all Good Clinical Practices (GCPs) and is further envisioned to work in the best interest of trial participants. But is it in the best interest of drug makers and medical researches as well or is the situation quite different? Looking in-depth, the European Medicines Agency (EMA) regulation regarding the disclosure of clinical trials information has the purpose to find the right balance between the public and research organizations. Undoubtedly, publishing studies–related...MORE >

Digital Recruiting of Trial Participants: Using Apps, Social Media and Search-Websites
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Published - 07.Jul.2015

Bringing to one’s attention the strict, Good Clinical Practice (GCP)- compliant and fast-pacing nature of clinical trials and the sponsors’ attempts to recruit as many suitable subjects as possible, in most of the cases the latter are seen to implement what traditionally works best for and in the Pharmaceutical industry. However, “what traditionally works best” may not be sufficient enough especially when there is a noticeable decrease in successful recruitment rates. What should be the next step then? Taking into...MORE >

A Two-by-two Trial Design and Behavior-treatment interaction
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Published - 30.Jun.2015
clinical data validation

Discovering a new pharmaceutical product or therapy is a process which requires compliance with all Good Clinical Practice (GCP) regulations. However, the complexity of this matter also lies in the fact that in order to obtain the most productive results, researchers need to integrate the most suitable and bias-free methods. Thus, the best implementation as well as assessment of the new drug depend on the so called double-blind randomized controlled trials (DBRCTs). These trials are perceived as the gold standard...MORE >

ACRES – Building towards the future of clinical research
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Published - 23.Jun.2015

When we talk about the Pharmaceutical, Medical and Clinical industry, the quality of researches and the outcomes, respectively, are the factors which define the progress as well as the success of these sectors. Meetings, conferences and other similar events are regularly being organized and carried out in order to tackle with an abundance of questions regarding the effects of Good Clinical Practices (GCPs) and their relation to each of the fields mentioned above. One such global meeting, precisely the meeting...MORE >

Understanding Randomized Controlled Trials: Why are they important?
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Published - 16.Jun.2015

The very history of clinical studies goes back to 600 B.C and ancient Babylon when the first recorded clinical trial was conducted by Daniel of Judah. What he did was simple but at the same time his report demonstrated significant influence for a jarringly long time – that of more than two millennia. Precisely, Daniel of Judah compared the results and effects of the vegetarian diet with those of the so called royal Babylonian diet. His experiment continued for more...MORE >

Is Clinical Trials Registration Needed and Why?
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Published - 09.Jun.2015

All clinical trials are required to be carried out in manners which reflect on Good Clinical Practice (GCP) regulations and demands to ensure patient’s safety and quality of data. However, there are cases when it is hard to find and recruit individuals who are suitable for the purpose of a given study. That is to say that this type of instances are possible to create additional complexities that might turn out to compromise the proper scientific completeness through falsifying data,...MORE >

Clinical Trials Operations Management for Emergency Care
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Published - 02.Jun.2015

Clinical trials represent the most expensive, recourse- and time-absorbing component of the whole drug development procedure. Operations within the biopharmaceutical field involve a wide variety of separate operations that include researching, collecting, estimating, systematizing and rationalizing data from a huge volume of sources. In order to ensure efficient Good Clinical Practices (GCPs), regulators urge sponsor organizations to provide a whole-system approach. Such approach will guarantee the well-being of patients and will also serve to orchestrate administrative and operational processes in...MORE >

Clinical trials for rare diseases: Challenges and Solutions
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Published - 26.May.2015

Many rare diseases are lethal, quickly progressing and debilitating. For this reason the principles of Good Clinical Practice (GCP) and Food and Drug Administration (FDA) regulations ask for adequate and on-time responses which will prevent as many fatal consequences as possible. However, the reality works quite the opposite way. One of the biggest difficulties is the delivery of positive results in a short period of time since clinical trials for rare diseases can take years. This puts at risk a...MORE >

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