Important industry news and company updates

Every clinical trial starts with the preparation of a detailed research protocol. But the question here is, are these protocols really necessary or are they simply some sort of formalities which place additional burden on researchers just to turn into an ever-growing pile of documents at the end? To start with, let’s define what protocols in clinical trials really stand for. A protocol represents a formal document which indicates all of the significant elements of a trial’s program. It is extremely...MORE >

One of the key duties of researchers is to ensure that the captured research information is accurate and answers the Good Clinical Practice (GCP) regulations and requirements. Only this way a complete integrity of database and, respectively, results can be achieved. However, there are plenty of occurrences when this is somehow neglected or accidentally omitted. In this case, if the clinical trial information which is stored in the database is incorrect, the outcomes based on that information could be incorrect...MORE >

As most of you know, Astra Nova offers a number of trainings. They vary from in-house courses, through online lessons, to webinars. We want to always stay abreast with the most actual, relevant and newest tendencies which accompany the Pharmaceutical, Clinical and Medical sector. Therefore, our courses cover industry-related topics which help specialists and sector-newcomers gain the required set of skills and knowledge. We transmit what we know and share our expertise. Those who want to expand their skills as...MORE >

Clinical data validation refers to a collection of activities by data management team to assure validity and accuracy of the clinical data. Data Validation is a process required : - at the Software level - at the Applications level - for human interactions at all levels The different types of Data inconsistencies are checked by the validation process are: -          Data complete -          Data legible -          Data consistent -          Data Logical -          Data Correct After validation of different types of data inconsistencies the data get converted to Valid and Cleaned...MORE >

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 >