Important industry news and company updates

There are plenty of factors which affect the clinical trial landscape. Sometimes it could be due to unpredicted patients’ behavior or reactions, while performing a study. Newly introduced guidelines which require immediate action different from pre-set processes are able to alter how Pharma is unfolding as well. Technological advancements can also dictate major changes. Developments and tech-driven practices, tools, methods and trends such as implementing electronic data capture, m-health or cloud computing are all forces which impact the research industry...MORE >

Pharmaceutical companies and clinical study organizations recognize Quality Assurance (QA) and Quality Control (QC) as extremely vital. They are critical not only to drug development and other related research processes but to patients’ safety as well. In this regard, sustaining quality, precision and compliance is a way to guarantee that pharmaceuticals and medicinal products are safe to use, while human subjects are protected from various trial risks. Therefore, sponsors who are responsible for Quality Assurance and Quality Controll utilize a...MORE >

Pharma is known as the industry which is slower in adopting ground-breaking technologies than other fields or businesses. It is true that there is a noticeable progress, and various examples of advanced technological use can be noted. And yet, companies take into account the possibility of risks and disadvantages that may arise. Slowly but surely, though, plenty of revolutionary methods are being deployed in clinics and research centers, enabling researchers and industry leaders to optimize their practices and related procedures....MORE >

People usually learn about clinical studies, results, projects, cases and other relevant topics by reading online sources or through social media. And while they pay attention on the content, they rarely focus on the design of the study itself. Even though it may seem as something irrelevant, it is, in fact, very crucial to the understanding of the results, findings of the trial and their quality. And when it comes to findings and evidence, the most reliable ones are proven...MORE >

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 >