Quality assurance plays a huge role when it comes to conducting 100% efficient clinical trial. Ever since the Pharmaceutical, Clinical and Medical industry has started to shape and contribute to the economic growth of one country, there has been an increasing focus placed by regulators on using quality systems throughout every step of a particular research. The integration of such systems is indicated to serve a number of purposes. Above all it promises fewer inefficacy rates when it comes to...MORE >

1. Free and certified training solutions By signing up for any of our free or commercial online courses you will obtain access to our Online Training Platform where you can learn and track individual or group performance. Astra Nova’s online training courses are developed by leading industry experts and are designed by leading user experience professionals to optimise the learning curve and to ensure compliance and unmatched user experience 2. Online Training Platform Our brand new Online Training Platform is surely one of...MORE >

Efficiency of clinical trials is probably the industry’s and government’s number one goal. It is so important that it is being discussed all over again by all stakeholders within the clinical research industry: industry, academia, government, nonprofit organizations, and patient advocates, clinical investigators, patients, payers, physicians, and regulators. Efficacy has been challenged though by many factors: access to well-characterized and often treatment naïve willing participants availability of qualified local investigators who are eager to conduct trials; the enhanced capacity of international sites the lower cost...MORE >

Advancement of the Medical, Clinical and Pharmaceutical industry relies on a number of factors. They vary from having the right and appropriately qualified personnel, through registering relevant clinical trials and being compliant to Good Clinical Practice (GCP) regulations, to fulfilling ethical obligations when it comes to trial volunteers and so on. The list is just endless. However, many people omit one and very crucial factor which plays major role for the successful unfolding of the sectors mentioned above. This particular...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 >

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 >