Reporting of adverse drug effects (ADE) represents one of the very crucial aspects in clinical research. Appropriate documentation and sufficient information about any such effect or reaction can make a huge difference in terms of patients’ safety and quality of pharmaceuticals which have been tested, manufactured and approved for general consumption. Being reported in online medical articles and other recourses, adverse events (or side effects which are regularly collected in randomized clinical trials) can help caregivers, practitioners, patients, reviewers and...MORE >

Cross-contamination in pharmaceutical manufacturing has become a huge concern not only to experts involved in the therapeutic market and pharma industry as a whole, but to the average person as well. It becomes a major topic of discussion among various communities. But what exactly is this? In essence, that is the ‘infection’, so to speak, of any material in process (starting material or intermediate product) or a finished drug with another material in process or pharmaceutical. It is critical for...MORE >

 The recent updates in the Good Distribution Practices by the European Commission. Astra Nova recently released an update of the GDP certification course, that contains all the relevant updates. This training is based on the international regulations for Good Distribution Practice (GDP) of pharmaceutical products for human use. The training looks into the practices of wholesale distributors and the proper ways and processes concerning the distribution of medicinal products, as well as the roles and responsibilities of all personnel stated in...MORE >

Clinical Research is witnessing a tremendous progress in the last couple of years. Despite the fact that many sees it as a relatively new discipline with relatively new developments, the idea behind carrying out trials with medical purposes is pretty much ancient. Thus, the very first officially known clinical study was performed by the Scottish physician James Lind back in 1747. His systematic research had the goal to prevent maritime diseases and find cure for scurvy – a disease now...MORE >

Mobile technology has gained a tremendous role in many different industries. But somehow its deeper presence has yet to be incorporated into clinical trials, as they have lagged a little bit behind. Even though mobile devices have been used as effective instruments that bring a variety of benefits to different areas, to some extent, research companies still remain reserved when it comes to relying on entirely technology-oriented practices. There are concerns related to the legal or regulatory-compliant settings coupled with...MORE >

  CTMSs or Clinical Trial Management Systems are gaining more and more popularity among pharmaceutical, medical and research sites as days go by. They are becoming such an integral part of study-related practices, that in 10 years’ time there will be hardly any company in the field without long-ago implemented software of this type. On top of offering excellent time- and cost-saving solutions, these tools deliver plenty of other advantages to clinical research specialists. Some of them include: Streamlined workflow Modernized and optimized...MORE >

What would we make of an industry if it’s not open to new tendencies or ground-breaking ideas? What would we make of an industry if it doesn’t welcome state-of-the-art approaches? What would we make of an industry if it is unable to handle any changes? Fortunately, the Pharmaceutical, Clinical, Medical and Research industry have all acknowledged that progress arrives with innovations, new methods to be used, and alterations to be made. After all, progress is not a constant. It is...MORE >

Companies that operate within the Pharmaceutical and Pharmacovigilance field and experts involved in the storage of drugs and/or other medicinal products are legally required to be fully aware of the requirements that accompany relevant practices. All professionals engaged in clinical studies of an investigational drug and its efficient preservation are expected to carry out the necessary set of actions and tasks in accordance with Good Storage Practice (GSP) formal guideline. Because of the seriousness of the matter and the importance of well-performed procedures that have...MORE >

For the last couple of years, clinical trials are known to become more and more digitally-oriented. There are various technological devices and software developments that are used to streamline good clinical practices. We have got mobile applications to help researchers perform routine tasks with patients involved. Trial participants, on the other hand, use wearables or their smartphones to send and receive reminders or important information from caregivers. Moreover, industry professionals do their best to improve life science globally by deploying...MORE >

Being a leader in providing clinical trials-related courses, we at Astra Nova aim to deliver the best training programmes that match our clients’ expectations. One such online course is Pharmacovigilance.   LOOKING AT THE BIGGER PICTURE…   Over the last few years, the number and complexity of clinical trials have both increased dramatically. The research industry is investing in state-of-the-art methods in order to advance more quickly and while doing so, it automatically changes the requirements that come with it. We now have m-health,...MORE >