Important industry news and company updates
The Role of a CRO in Risk-Based Monitoring
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Published - 19.May.2015

The clinical trial industry is marching towards maturing. However, its advancement confronts stakeholders across the clinical research field with a myriad of challenges. Among the difficulties which stand between sponsors as well as project managers and the completely smooth run of studies are the increasing costs, additional expenses and the constant insisting of regulators to apply more effective monitoring approaches that will guarantee improved Good Clinical Practices (GCPs). One such technique turns out to be risk-based monitoring (RBM). Still, in...MORE >

Adaptive Clinical Trials: Meaning, Benefits and Challenges
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Published - 12.May.2015

Developing a brand new pharmaceutical product is lengthy and costly process. For the past several decades it has been indicated that the extensive research does not equal extensive and productive results which turns out to be a real drawback. The lack of sufficient development in the form of new medicines has challenged a number of regulators and researchers to look for advanced methods that will help reduce the unacceptably low level of productiveness. Finding out that the classically structured design...MORE >

Informed Consent in Clinical Trials: 5 New Trends and Aspects
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Published - 05.May.2015

There are millions of volunteers who take part in clinical trials every single year. Before participating in any government- or industry-sponsored research, every subject has the right to be informed about what will happen next and how it will happen. Such process in which subject A is provided with the necessary details by subject B is called informed consent. But let’s view this from a slightly larger and more thorough prism. Different trials, of course, carry different risks and/or benefits. Full...MORE >

Remote Clinical Trials – Stepping into the future of clinical practices!
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Published - 28.Apr.2015
clinical data validation

The idea of innovation circles all around the Pharmaceutical industry. In this sector experts are seeking to develop something new, something working and something that will ostensibly improve life science on a global scale. Still though, the approaches used when carrying out a research could be said to be fairly changed and rather similar to those used more than 20 years ago. And when we talk about progress, such antiqued and familiar procedures are inexcusable. In order to break these...MORE >

Clinical Trials Outsourcing:  Globalization and Ethical Concerns
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Published - 21.Apr.2015

Outsourcing has been adopted in many industries as a business strategic step towards globalization of actual practices and tendencies. In the pharmaceutical world this trend can be absorbed as something relatively new. In order to produce a brand new medical product, pharmaceutical companies are expected to part with $1 billion on average. A huge percentage of these expenses is dedicated to human clinical trials as they have the most pivotal role before delivering a product to market. The increasing interest...MORE >

Evidence-Based Practice – Knowledge is Power!
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Published - 15.Apr.2015
Clinical Trials Risk Management

For the last couple of years, there has been a growing need for more efficient as well as effective good clinical practices. The most solid expectation of current pharmaceutical and medical processes is based on high-quality, result-delivering and result-centered governance. Simply put, organizations and companies that want to produce the best possible outcomes in larger medical landscape are expected to look for new opportunities that will be able to improve the knowledge base and will also enhance patient care. Giving...MORE >

Computer System Validation – what you need to know!
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Published - 08.Apr.2015

Computer system validation (also known as computer validation or CSV) is part of the particularities which have an impact on Good Manufacturing Practice in the pharmaceutical and clinical industry. This system validation is seen as something that is more than just a compliance necessity. Why is that so? The answer is simple. CSV represents a highly pivotal aspect in the sectors mentioned above because it is a way of exploring different business computer systems so that one company or another...MORE >

Good Documentation Practices – What, How and Why?
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Published - 31.Mar.2015

It is the big, small and medium things that should be taken into consideration in order to have Good Clinical Practice. So in other words, everything should be touched with extreme precision in order to receive the outcomes which are expected and needed. Among the most frequently arising concerns in all sorts of clinical researches is the inaccurate or inadequate documentation practice. Back in 2009, European Medicine Agency (EMA) placed source documentation issues among the 10 most commonly cited insufficiencies...MORE >

Risk-based monitoring: The whole picture
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Published - 24.Mar.2015

Over the past few years, we notice a dramatic increase and change in the complexity of clinical trials. Nevertheless, there are things that haven’t gone through severe alterations and still preserve their initial functions. For instance, sponsors are still responsible for ensuring that all of the participants in one study or another are safe and that the integrity of data attained from the medical research is adequately maintained. Monitoring of clinical trials also remains as one of the most cardinal approaches...MORE >

E-learning courses: Paving the future of education and training
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Published - 17.Mar.2015

Industry after industry realizes the pivotal role of e-learning, or online learning, which either define or contribute to the successfulness of every company. The future development of the medical world requires innovative approaches which promise saturated effectiveness and excellent results. E-learning guarantees this and serves as a driving force that pushes the Pharma industry up the ladder. Since clinical trials ask for absolute productiveness, the levels and methods of training become a matter of utmost importance. But what exactly stays behind...MORE >

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