Important industry news and company updates
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

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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 >

5 Useful Tips for Optimised Patient Recruitment Processes
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Published - 26.Jan.2016

Volunteers are the scaffolding of any clinical trial. Without having enough or eligible number of people, clinical research can hardly be described as a research at all, let alone as a successful or active one. Respectively, when we discuss what might be the reasons for failure in this particular field, we cannot neglect the factor which reflects on patient outreach. In other words, one of the major challenges when it comes to the longevity and quality of clinical trials is...MORE >

Management Review according to Good Manufacturing Practice: How often should these reviews occurred and what should they cover?
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Published - 22.Jan.2016
Management Review according to Good Manufacturing Practice

A Management Review becomes necessary to "identify opportunities for continual improvement of products, processes and the system itself". Top Management should attend. For most sites this is the Senior Management Team who report to the overall head of the site. ISO 9001, the source of Management Reviews, doesn’t state this. As described in the FDA’s Quality System Model firstly “when developing and implementing new quality systems, reviews should take place more frequently than when the system has matured”. This is...MORE >

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