Important industry news and company updates

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 >

GLP stands for Good Laboratory Practice. The GLP guideline deals with the organization, process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data. GLP must be applied to non-clinical studies that are conducted to examine the properties of a chemical and/or the safety of that chemical to humans, animals and the environment, for example:  Pharmaceuticals (Human and veterinary) Pestivides Industrial Chemicals Cosmetics Feed and feed activities The definition of “non-clinical...MORE >

Good Clinical Practice This is not the first time we speak about Good Clinical Practice regulations (you can read more on our blog: Essential Documents according to Good Clinical Practice , ICH GCP Certification  and ICH Good Clinical Practice Online Training, but it is a fact that this is the most important and in the same time reviewed source of information about documentation and processes within the clinical research industry. Here is a brief description for the ones, who are still...MORE >

One of the key purposes of clinical trials is to make sure that newly discovered medicines are tested, safe to use and effective. The medical consumption should not endanger humans and, respectively, should be absolutely risk-free when it comes to humans lives. In this regard, making sure that patients’ are safe and respecting their rights are two tasks of high priority. As part of Good Clinical Practice (GCP) standards and other regulations by the FDA, they should never be neglected....MORE >

The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today’s distribution network for medicinal products is increasingly complex and involves many players. These guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain. Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products. According to Article 1(17) of Directive...MORE >

Definition of research nurse Nurse is generally the person who is educated to take care of care of the sick or disabled people, watch over them and their symptoms and make sure they are safe and well. This is a generous profession that requires a lot of effort but also sense of humanity and compassion. The difference between a nurse and a research nurse comes with the type of medications and treatments you use in order to help and cure the patient....MORE >

Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of...MORE >

Anyone who is part of clinical researches, procedures and the industry as a whole is expected to know the importance of being compliant with a number of rules and regulations. Why is this so? Well, to present it in the simplest way possible, compliance with all of the requirements in clinical studies serves to guarantee several things: Integrity of data Good results Being legally obliged (or lawful) Bound to Good Clinical Practices Responsive Quality of procedures Of course these are just a few of the aspects which...MORE >

Every clinical research largely relies on the recruitment of volunteers. Why? Simply put, without patients no clinical trial will be possible to be implemented. The lack of people will not allow researchers to test medicinal products on anyone. When there is enough number of research participants, physicians can proceed on. The progress of trials, then, also depends on the researchers themselves. But most importantly, the proper development of all procedures lie within the responsibilities of the research conductors and how,...MORE >

The Pharmaceutical industry is not a constant. It is rather changing and receiving plenty of internal and external impacts. In clinical research sometimes the impacts derive directly from trial participants and often the lack of enough trials can turn into a major issue. Because there is an enormous emphasis on Managed Care Organizations, the research sectors are migrating from their currently adopted environments, while trying to achieve partnership with MCOs. But are this kinds of partnerships easily achievable and how...MORE >