Important industry news and company updates

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 >

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 (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 >

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 >

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 >

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 >

  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 >

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 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 >

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 >