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Systematic reviews represent a fundamental part of evidence-based healthcare. But why is it called systematic? How does it gain this adjective? In clinical trials a review can be defined as systematic only when it covers several key elements. Precisely, a systematic review is the one that is founded on a clearly structured question, is related to a relevant study, assesses its quality and efficacy, and lastly, offers a summary of empirical evidences accompanied by effective approaches. It is exactly due...MORE >

Providing appropriate research evidence is really important for clinical trials as it speaks for their quality, integrity, consistency and reliability. With the abundance of published sources on the Internet, however, keeping up with updated and new research evidence turns into a task too difficult to cope with. This is not surprising, taking into consideration what statistics have shown in the past. Thus, within the second half of the 20th century there were approximately 20,000 journals being published annually along with...MORE >

A consumer cannot define whether a drug or another medicinal product is valid and safe to use. Sometimes not even a testing alone can determine and ensure 100% quality of pharmaceuticals. For this reason, regulators use Good Manufacturing Practices (GMPs) and instruct regulations to assure that drugs are developed under appropriate conditions, while preserving quality, integrity and usability at every step. Good Manufacturing Practice is part of quality assurance in clinical trials and is related to both concerned with both production...MORE >

Usually, signals are detected when assessing and reviewing individual case safety reports (ICSR) in an individual or cumulative way. In relation to this, the signal management process can be viewed as a set of activities the primary goal of which is to determine whether, based on an examination of ICSRs (including combined data from active surveillance systems or studies, literature information or other data sources) there are new hazards associated with an active medicinal product or whether already discovered and...MORE >

Volunteers are the scaffolding of any clinical trial. Without having enough or eligible number of people, clinical research can hardly be described as a research at all, let alone as a successful or active one. Respectively, when we discuss what might be the reasons for failure in this particular field, we cannot neglect the factor which reflects on patient outreach. In other words, one of the major challenges when it comes to the longevity and quality of clinical trials is...MORE >

A Management Review becomes necessary to "identify opportunities for continual improvement of products, processes and the system itself". Top Management should attend. For most sites this is the Senior Management Team who report to the overall head of the site. ISO 9001, the source of Management Reviews, doesn’t state this. As described in the FDA’s Quality System Model firstly “when developing and implementing new quality systems, reviews should take place more frequently than when the system has matured”. This is...MORE >

Every clinical research company along with its employees undergoes different inspections and audits before, during and after the start of clinical trials. The objectives and purposes of these procedures include enhancing patients’ safety, the ways of treatment, plus increasing the standard of care. Therefore, check-ups of this kind are equally important for healthcare, for the industry, for clinical trial participants and for research organisations as well. How has the term “audit” evolved over time? Despite the current significance and major role of...MORE >

What is a Wholesale Distribution Authorisation Human  WDA(H)? The WDA(H) is the new licence for wholesale dealers, which is issued by the MHRA to UK wholesalers. The previous version of the Wholesale Licence (WL) allowed the licence to trade in medicines for human use, and specifically in Pharmacy (P), Prescription Only Medicines (POM), Traditional Herbal Medicine Products (THMP) and General Sales List (GSL) medicines. Any organisation or individual purchasing or selling pharmaceutical product must have a valid Wholesale Dealer's License (WL) from the...MORE >

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 >