Important industry news and company updates

No matter if clinical trials are sponsored by the industry or government, they have the goal to improve or discover completely new ways for treating diseases. But most of all, researches are capable of dictating the advancement of medicine and healthcare. There are millions of volunteers who realize how important for the sector and humans health trials are and decide to take part in such investigations. However, prior to their participation, every volunteer has the right to know what to expect...MORE >

All drug development procedures involve producing a large volume of documentation. Such documentation includes consistent, reliable and accurate data which is kept during and after the performance of a clinical trial. As explained in the ICH GCP Guideline 1.51, documentation (or source documentation) represents “all information in original records and certified copies of original records of clinical findings, observation, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original...MORE >

Definition of Good Storage Practice Conditions under which medicinal products are maintained can affect their final quality as well as their merchantability. For this reason, Good Storage Practice requires all pharmaceutical products to be stored in the most adequate ways and in the most proper conditions in order to ensure that their quality will not be compromised and no unanticipated consequences will occur after these products reach consumption. Storage plays an integral role in the total drug control system. Of course,...MORE >

Identifying potential risks as early as possible and making risk minimization plans in order to deal with the identified risks or at least mitigate them is cornerstone for anyone involved in pharmacovigilance. In this regard, “signal detection” refers to any particular process which has the goal to discover signs of an unanticipated drug safety issue. Such safety problems may be found in the face of newly occurred adverse drug reactions (ADRs) or some sort of a change of the frequency...MORE >

GDP stands for many things, including Good Distribution Practice. Good Distribution Practice deals with the guidelines for the proper distribution of medicinal products for human use. GDP is defined as: "The measures that need to be considered in the storage, transportation and distribution of any registered product /notified cosmetic and its related materials such that the nature and quality intended is preserved when it reaches the consumer"   The GDP standards describe the distribution process from the manufacturing facilities to the end user,...MORE >

Clinical researches are changing in a lot of ways. The study environment and techniques are incorporating more and more technology-oriented trends in order to keep up with the rest of the industry. Regulations are changing, trials designs become more adaptive, strategies for clinical development optimization are shifting in attempt to be more responsive to relevant diseases, for example, and new treatment methods are tested in order to improve healthcare at rates faster than before. The most important thing, however, is...MORE >

When we compare clinical trials for rare diseases and clinical trials for non-rare diseases we can see that the participation of people in the first type has been said to be extremely low. A recent survey shows that out of 24,088 clinical trials, 2,759 (11, 5 %) of them were defined as rare disease trials in which under 50 individuals are indicated to demonstrate interest in taking part in one of them. In this regard, recruiters experience major difficulties in...MORE >

It is not a secret that clinical research is an industry providing many people with opportunities to have a regional or international career. It is not only a great place to earn a good to high salary, but you can also travel a lot, work towards people’s good fortune and be able to move around different departments and get different experience. Unlike doctor’s profession it is rare clinical research professionals deal directly with patients, which can be sometimes really stressful...MORE >

It takes time, a lot of recourses and substantial research to develop a new drug that is effective and serves a medical purpose. Nevertheless, it has been indicated that not always the process of researching leads to positive and productive outcomes, which becomes a major setback in the Pharmaceutical industry. In order to avoid such drawbacks that prevent the industry from quicker progress, regulators and researchers try to find more advanced ways that will lead to more adequate results. Realizing...MORE >

We can’t deny the fact that according to modern-day equations and measurements, corporate value is equal to the number of external people (users, investors, sponsors etc.) attracted to the service or products being provided. To present it differently, the more sides are involved, the wider impact the business is said to have. In order businesses to be highly effective and more encompassing, they need to reach as many people and parts of the world as possible. It is called globalization...MORE >