Important industry news and company updates

Clinical trials registry eliminates any risks of possible selective reporting
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Published - 16.Nov.2015
Clinical trials registry eliminates any risks of possible selective reporting

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 >

Clinical Trials Risk Management Online Training
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Published - 13.Nov.2015
Clinical Trials Risk Management

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 >

Becoming a research nurse – full guideline
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Published - 12.Nov.2015
Becoming a research nurse - full guideline

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 regulations of ICH GCP
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Published - 11.Nov.2015
Essential Documents regulations of ICH GCP

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 >

Ethical Principles in CR involving Human Subjects Advantages and Usefulness of the Training
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Published - 09.Nov.2015
Ethical Principles in CR involving Human Subjects Advantages and Usefulness of the Training

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 >

Are Ethical Principles in Clinical Research Important?
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Published - 06.Nov.2015
Are Ethical Principles in Clinical Research Important?

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 >

Managed Care Organizations and Clinical Trials
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Published - 05.Nov.2015

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 >

Research Protocols in Clinical Trials
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Published - 04.Nov.2015
Research Protocols in Clinical Trials

Every clinical trial starts with the preparation of a detailed research protocol. But the question here is, are these protocols really necessary or are they simply some sort of formalities which place additional burden on researchers just to turn into an ever-growing pile of documents at the end? To start with, let’s define what protocols in clinical trials really stand for. A protocol represents a formal document which indicates all of the significant elements of a trial’s program. It is extremely...MORE >

Importance of Query Management in Clinical Studies
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Published - 03.Nov.2015

One of the key duties of researchers is to ensure that the captured research information is accurate and answers the Good Clinical Practice (GCP) regulations and requirements. Only this way a complete integrity of database and, respectively, results can be achieved. However, there are plenty of occurrences when this is somehow neglected or accidentally omitted. In this case, if the clinical trial information which is stored in the database is incorrect, the outcomes based on that information could be incorrect...MORE >

The usefulness of Astra Nova’s Risk-based Monitoring Training
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Published - 02.Nov.2015
ICH GCP certification

As most of you know, Astra Nova offers a number of trainings. They vary from in-house courses, through online lessons, to webinars. We want to always stay abreast with the most actual, relevant and newest tendencies which accompany the Pharmaceutical, Clinical and Medical sector. Therefore, our courses cover industry-related topics which help specialists and sector-newcomers gain the required set of skills and knowledge. We transmit what we know and share our expertise. Those who want to expand their skills as...MORE >

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