A successful and efficient clinical study is defined by its results. But before investigators can reach to any final conclusions, the whole research undergoes many different process – from hiring appropriate staff, through additional training and preparation, to preparing study protocols, finding volunteers, collecting data, sending that data to the Food and Drug Administration (FDA) for approval and so on and so on. The process can sometimes really seem to be without an end. Still, one of the key responsibilities...MORE >

Using Electronic Data Capture methods make the work of researchers and staff members smoother and easier. Such systems offer cost- and time-efficient results without compromising on quality. Other benefits of EDC include: - Data efficiency EDC systems are designed in a manner that guarantees for the efficiency of the data which is being collected. Edit checks and revisions are installed into the system, enabling researchers to monitor the data and make sure it is in the right format, consistency and range before...MORE >

Besides getting a BA or MA degree in medicine, pharmacy or any other of the hot science disciplines, people working at the pharma industry, including the clinical research sector, are just like doctors and need to cover many additional professional courses throughout their career. However, training while having our full-time job and additional social responsibilities might be challenging and very frustrating. What about In-house training? This is only one of the many reasons why e-learning in the pharma industry is getting even more...MORE >

Medical professionals who are interested in gaining the credentials necessary to become clinical data managers need to get Clinical Data Management Certificate. A certificate programme provides with an understanding of how clinical trials for pharmaceutical drugs and other medical products are designed. Prospective students should have significant work experience and a basic understanding of natural sciences and laboratory sciences before taking such a course of study. Typically the courses included in a clinical data management certificate program cover clinical topics, regulatory topics,...MORE >

UHPLC Analysis in Biopharmaceutical R&D and Production Free Webinar is with free registration and it has been set for 11th of November. The webinar will summarize current trends in UHPLC applications for biomolecules. Case studies will illustrate the potential of using UHPLC for applications, which are frequently used in development and production of biologics, biosimilars, and biobetters. New biocolumn developments supporting these techniques will be presented. Hyphenation of these LC Methods with sophisticated techniques such as mass spectrometric, light scattering, or...MORE >

GMP stands for Good Manufacturing Practice guidelines and it is a set of regulations, which medicine manufacturers have to comply with. It is a part of the international GxP standards but of course, like most of them, there are a few specifics depending on the location. In this article we will review the GMP certification requirements in the UK. What is a GMP certification? The MHRA or the Medicines & Healthcare products Regulatory Agency is the agency that protects public’s health by making...MORE >

Training solutions for the pharma and clinical research industry Astra Nova Ltd is a UK-based training company dedicated to providing training solutions within the Pharmaceutical and Clinical Research industries. Our goal is to establish the biggest international network of trainers, which would allow companies worldwide access to an infinite number of topics to train their staff in. Individual and corporate online training By signing up for any of our free or commercial online courses you will obtain access to our Learning Management System...MORE >

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 >