Important industry news and company updates

Planning is essential to prolific clinical studies. The description of various external and internal factors can serve as guidance to sponsors, physicians, researchers and other members of stuff. Therefore, every clinical research starts with the preparation of a detailed study plan. In the Pharmaceutical, Clinical and Medical sector, this study plan is most commonly referred to as research protocol. And just as any other required study procedure and documentation, the development of a protocol must also adhere to Good Clinical...MORE >

Everyone is talking about Big Data and no matter the industry is, it is part of each sector, including the clinical research area too. But big data is nothing without a methodology of managing this data. This is exactly what Clinical Data Management is all about. And of course, it includes many strict regulations, because we need to ensure not only the integrity of study results but the quality and safety of clinical trial participants as well. Clinical Data Management is...MORE >

As most of you already know, we are closely working with Training or Quality Assurance Managers at clinical research and pharma companies that use Astra Nova’s training services. One of the key courses they need is the Good Clinical Practice training. NB! You can read more about the ICH GCP training and the different online and in-house versions here: https://crotraining.co.uk/should-i-choose-good-clinical-practice-online-training-or-a-seminar/ Number one question I receive is: Do you certify people with your Good Clinical Practice courses and what value these certificates have....MORE >

Data Management is a very crucial aspect of clinical research, explaining its burst in popularity and the pinned focus by the whole industry, as its proper handling can lead to generation of quality, reliable and statistically sound data from clinical trials, it can boost processes speed, reduce risks, thus reducing costs and optimizing efficiency. After our introductory webinar on the topic and the amazing feedback we got from you, we decided to set up another one, with a more advanced focus...MORE >

As most of the clinical research insiders would agree - the clinical industry is heavily regulated by different governmental and third-party regulations. The first major success in bringing all of them together on the same side - the side of global safety and efficiency - was achieved during the International Conference of Harmonization (ICH). With the Declaration of Helsinki of 1977  many countries like the USA, the UK and Japan have adopted the ICH GCP guidelines and then almost every other...MORE >

The successful research changes across time and progresses. This change, however, moves in accordance with the advancement of technologies and is also responsive to the requirements of all Good Clinical Practices (GCPs). And since clinical research largely depends on the collection and preservation of data, the methods, tools and systems used are of a paramount importance. Acknowledged as navigators for results, they need to be not only up-to-date but effective too, because being updated is not always an equivalent of...MORE >

Astra Nova Ltd. has been taking care of the training preparation of thousands of clinical research professionals in the past couple of years. We are happy to assist companies as well as individuals in making sure they follow regulations in the right and, of course, the most efficient way. One of the key topics people have been focusing on is that of Good Clinical Practice trainings. With the technological progress we became witnesses of a tremendous educational turn in the...MORE >

Clinical research has the purpose to ensure the effectiveness and safety of newly developed medications for human consumption. Crucially, researches are envisioned as the practices which can largely contribute to, form and promise better integrity of health knowledge, improved health of people worldwide and more efficient ways to treat patients and prevent diseases. All of this should be done in consistence with Good Clinical Practice (GCP) regulations, FDA requirements and others. However, to perform clinical research, there is a need...MORE >

For the last couple of years the range, size and complexity of clinical trials have increased, while their nature has changed notably. Researches turn out to be more digitally oriented and far more technologically dependent. And with this advancement, the demand for constant updates in terms of research practices is ongoing. In attempts not to let clinical trials fall behind with currently introduced methods, the FDA keeps encouraging new and more effective strategies which are still compliant with Good Clinical...MORE >

The research environment is in a constant process of being affected by many external and internal factors. Things such as keeping privacy of patients, financial misbalances, not enough trained specialists, lack of trial participants, outdated trial methods, unreliable systems, incompliance with Good Clinical Practice (GCP) regulations, too much transparency, and the opposite, deprivation of data transparency are all very fragile corners in the Pharmaceutical, Medical and Clinical sector that can turn to problematical points quite easily. They are impactful enough...MORE >