Important industry news and company updates
System Electronic Records and Electronic Signatures in Clinical Trials
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Published - 30.Mar.2016

The FDA’s regulation on electronic records and electronic signatures represents an equal approach that eases the management of paperless systems. Such systems are said to bring a great variety of advantages like: reduced cost when it comes to data storage; much better ability to merge, exchange and search data; speeded up process of information exchange; decreased percentage of variability and errors.  Electronic records and electronic signatures have the same meaning and importance as paper records and hand-written signatures. In essence, Electronic...MORE >

What are Astra Nova’s Top 5 Online Clinical Research Courses?
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Published - 24.Mar.2016
Top 5 Online Clinical Research Courses

Proper education and sufficient training in the field of clinical research both have gained and continue to gain bigger importance during the last years. While 10 years ago, for instance, it might have been enough for a person to be given a specific job description with the expectation that he/she would be able to fit in the position one way or another. With the help of qualified mentors, jumping into a completely new role proved to be much easier even...MORE >

Continued Growth in the Clinical Outsourcing Market By 2020
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Published - 16.Mar.2016
Continued Growth in the Clinical Outsourcing Market By 2020

The following couple of years are expected to construct a truly proliferating timeframe for the clinical trial sector. We often hear how joining the field is one of the wisest decisions to make when it comes to one’s professional development. And now is just the right time to finally do it.  There are noted improvements in the knowledge and treatments of a number of serious diseases. But this knowledge is also combined with the use of innovative technologies, adoption of...MORE >

5 Most Useful Books on Clinical Research
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Published - 09.Mar.2016
Most Useful Books on Clinical Research

It is true that industry after industry embark on new practices which are highly dependent on technology. That’s become something natural even when it comes to the Pharmaceutical, Clinical and Medical sector as well. Whether it is to perform a task, to conduct a regular check-up routine, carry out a trial, implement quality control and assurance procedures, recruit patients, publish information and so on, clinical research widely relies on various devices and technological developments. However, when we talk about learning,...MORE >

Social Media: Valuable Tool in Clinical Research
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Published - 01.Mar.2016
Social Media Valuable Tool in Clinical Research

In our fast developing world pretty much all kinds of advancements depend on the symbiosis between people and technology. Using computers and other electronic devices has become so fundamental that without them any type of innovation or progress turns out to be unimaginable, not to say impossible. Technology opens many doors and provides with innumerable sources of valuable information. But to learn about something and to gain knowledge about one subject or another in order to improve the current status...MORE >

What are the similarities and differences between clinical researches and clinical audits?
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Published - 23.Feb.2016
similarities and differences between clinical researches and clinical audits

Quality has evolved from a simple term to unconditional requirement that has an integral role in healthcare. Quality of services should be preserved, quality of pharmaceuticals should be guaranteed by means of quality storing and distributing practices. There is quality of care, quality treatment, quality data management planning/plans, quality control systems, quality management and so on. The list of quality-related basics in clinical research is endless. In relation to this, clinical audits and researches have a well-established history in terms...MORE >

5 Key Steps to Perform Successful Systematic Reviews
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Published - 17.Feb.2016
5 Key Steps to Perform Successful Systematic Reviews

Systematic reviews represent a fundamental part of evidence-based healthcare. But why is it called systematic? How does it gain this adjective? In clinical trials a review can be defined as systematic only when it covers several key elements. Precisely, a systematic review is the one that is founded on a clearly structured question, is related to a relevant study, assesses its quality and efficacy, and lastly, offers a summary of empirical evidences accompanied by effective approaches. It is exactly due...MORE >

What is the role of systematic reviews in clinical trials?
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Published - 09.Feb.2016
What is the role of systematic reviews in clinical trials

Providing appropriate research evidence is really important for clinical trials as it speaks for their quality, integrity, consistency and reliability. With the abundance of published sources on the Internet, however, keeping up with updated and new research evidence turns into a task too difficult to cope with. This is not surprising, taking into consideration what statistics have shown in the past. Thus, within the second half of the 20th century there were approximately 20,000 journals being published annually along with...MORE >

Good Manufacturing Practice and the Importance of Relevant Documentation
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Published - 03.Feb.2016
Good Manufacturing Practice and the Importance of Relevant Documentation

A consumer cannot define whether a drug or another medicinal product is valid and safe to use. Sometimes not even a testing alone can determine and ensure 100% quality of pharmaceuticals. For this reason, regulators use Good Manufacturing Practices (GMPs) and instruct regulations to assure that drugs are developed under appropriate conditions, while preserving quality, integrity and usability at every step. Good Manufacturing Practice is part of quality assurance in clinical trials and is related to both concerned with both production...MORE >

ICRS and signal management in Pharmacovigilance
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Published - 28.Jan.2016
Signal detection

Usually, signals are detected when assessing and reviewing individual case safety reports (ICSR) in an individual or cumulative way. In relation to this, the signal management process can be viewed as a set of activities the primary goal of which is to determine whether, based on an examination of ICSRs (including combined data from active surveillance systems or studies, literature information or other data sources) there are new hazards associated with an active medicinal product or whether already discovered and...MORE >

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