Important industry news and company updates

The benefits of crowdfunding for clinical trials
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Published - 14.Sep.2015

Contemporary science is in a rush for quick results. However, when we talk about clinical researches and the Pharmaceutical industry, sometimes results do not come that fast. There is a number of different drawbacks and obstacles which, quite often, become an inseparable part of various research practices. Such holdbacks turn into the biggest challenges which every company is expected to deal with in the most adequate manner so that the study process can continue further on. Whether it is due...MORE >

The Importance of Privacy of patients and confidentiality of clinical trials information
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Published - 07.Sep.2015
Clinical Data Management

Taking part in clinical trials happens voluntarily and it is entirely up to the subject to decide whether to continue their participation in the trial or to terminate it completely. Of course, such participations are surrounded by unavoidable formalities and requirements. One such requirement is for people to submit personal data to the board of researchers before the start date. This information along with the medical records of the patient are supposed to be adequately maintained and preserved during and...MORE >

Astra Nova covers another milestone by the launch of its new Website and LMS system
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Published - 01.Sep.2015

Astra Nova’s recent development is the launch of their new website and online learning platform - LMS (LEARNING MANAGEMENT SYSTEM). The new website presents awiderange of relevant opportunities across web technology, e-learning and continuing education in the health professions. Astra nova learning management system is designed to automate and streamline continuing medical education (CME) in medical associations, academic medical centres, education companies, and healthcare systems. Astra Nova is a UK-based training company dedicated to providing education solutions within the Pharmaceutical and Clinical Research...MORE >

Quality Systems in Clinical Trials – The Tools for Optimal Results
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Published - 31.Aug.2015

Looking from a wider perspective, quality stands for a set of characteristics that some sort of service or a product is expected to have in order to be responsive to different requirements, laws, legislations and other formal documents. The concept of quality in the Pharmaceutical sector and clinical trials specifically, is a complex one. It can be defined in various manners depending on the used context and subject matter. Generally speaking, when it comes to clinical studies quality is explained...MORE >

Risk-Based Quality Assurance – The Benefits
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Published - 24.Aug.2015

In any industry which deals with product–development processes, quality assurance becomes an integral part of all of their procedures. When it comes to clinical trials and the Pharmaceutical, Medical and Clinical sector, making sure that high quality is achieved supports Good Clinical Practice (GCP) principles. What is more, it adds up to other quality practices, standards and requirements, thus having a direct impact on the overall relative industry performance. Ever since these particular branches have started to shape and contribute to...MORE >

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 >

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