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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 >

Clinical Data Validation
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Published - 30.Oct.2015
clinical data validation

Clinical data validation refers to a collection of activities by data management team to assure validity and accuracy of the clinical data. Data Validation is a process required : - at the Software level - at the Applications level - for human interactions at all levels The different types of Data inconsistencies are checked by the validation process are: -          Data complete -          Data legible -          Data consistent -          Data Logical -          Data Correct After validation of different types of data inconsistencies the data get converted to Valid and Cleaned...MORE >

Why Query Management in Clinical Trials is Useful?
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Published - 29.Oct.2015
Query Management in Clinical Trials

A successful and efficient clinical study is defined by its results. But before investigators can reach to any final conclusions, the whole research undergoes many different process – from hiring appropriate staff, through additional training and preparation, to preparing study protocols, finding volunteers, collecting data, sending that data to the Food and Drug Administration (FDA) for approval and so on and so on. The process can sometimes really seem to be without an end. Still, one of the key responsibilities...MORE >

Advantages of Electronic Data Capture software?
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Published - 28.Oct.2015

Using Electronic Data Capture methods make the work of researchers and staff members smoother and easier. Such systems offer cost- and time-efficient results without compromising on quality. Other benefits of EDC include: - Data efficiency EDC systems are designed in a manner that guarantees for the efficiency of the data which is being collected. Edit checks and revisions are installed into the system, enabling researchers to monitor the data and make sure it is in the right format, consistency and range before...MORE >

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