When we talk about medical or clinical research, Good Clinical Practice is usually referred to the pivotal idea of compliance with certain regulations, guidelines, rules and laws which serve to ensure quality of data and guarantee for the well-being of the participants in a specific trial. In order to outline the importance of ICH-GCP, here we are listing 13 core principles: 1. Conduct trials according to: Ethical principles from DoH, Consistent with GCP Applicable regulatory requirement(s) 2. Before initiating, weigh risks against benefit (participant and...MORE >

Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible (EU Directive 2001/20/EC in Article 1 (Scope)).  When inspectors identify non-compliance at a particular investigational site with potential impact on...MORE >

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 >