Important industry news and company updates
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 >

What makes clinical audits important?
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Published - 19.Jan.2016
clinical trials audits

Every clinical research company along with its employees undergoes different inspections and audits before, during and after the start of clinical trials. The objectives and purposes of these procedures include enhancing patients’ safety, the ways of treatment, plus increasing the standard of care. Therefore, check-ups of this kind are equally important for healthcare, for the industry, for clinical trial participants and for research organisations as well. How has the term “audit” evolved over time? Despite the current significance and major role of...MORE >

Key factors for obtaining a wholesale dealer`s license
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Published - 15.Jan.2016
Key factors for obtaining a wholesale dealer`s license

What is a Wholesale Distribution Authorisation Human  WDA(H)? The WDA(H) is the new licence for wholesale dealers, which is issued by the MHRA to UK wholesalers. The previous version of the Wholesale Licence (WL) allowed the licence to trade in medicines for human use, and specifically in Pharmacy (P), Prescription Only Medicines (POM), Traditional Herbal Medicine Products (THMP) and General Sales List (GSL) medicines. Any organisation or individual purchasing or selling pharmaceutical product must have a valid Wholesale Dealer's License (WL) from the...MORE >

7 Fundamental Questions to Ask About Clinical Trials
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Published - 12.Jan.2016
7 Fundamental Questions to Ask About Clinical Trials

No matter if clinical trials are sponsored by the industry or government, they have the goal to improve or discover completely new ways for treating diseases. But most of all, researches are capable of dictating the advancement of medicine and healthcare. There are millions of volunteers who realize how important for the sector and humans health trials are and decide to take part in such investigations. However, prior to their participation, every volunteer has the right to know what to expect...MORE >

Definition and Purpose of effective Data Management Planning
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Published - 11.Jan.2016
Definition and Purpose of effective Data Management Planning

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 >

Receipt of materials and pharmaceutical products according to Good Storage Practice
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Published - 08.Jan.2016
Good Storage Practice

Definition of Good Storage Practice Conditions under which medicinal products are maintained can affect their final quality as well as their merchantability. For this reason, Good Storage Practice requires all pharmaceutical products to be stored in the most adequate ways and in the most proper conditions in order to ensure that their quality will not be compromised and no unanticipated consequences will occur after these products reach consumption. Storage plays an integral role in the total drug control system. Of course,...MORE >

The Importance of Signal Detection in Pharmacovigilance
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Published - 05.Jan.2016
The Importance of Signal Detection in Pharmacovigilance

Identifying potential risks as early as possible and making risk minimization plans in order to deal with the identified risks or at least mitigate them is cornerstone for anyone involved in pharmacovigilance. In this regard, “signal detection” refers to any particular process which has the goal to discover signs of an unanticipated drug safety issue. Such safety problems may be found in the face of newly occurred adverse drug reactions (ADRs) or some sort of a change of the frequency...MORE >

Good Distribution Practice guidance
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Published - 04.Jan.2016
Good Distribution Practice guidance

GDP stands for many things, including Good Distribution Practice. Good Distribution Practice deals with the guidelines for the proper distribution of medicinal products for human use. GDP is defined as: "The measures that need to be considered in the storage, transportation and distribution of any registered product /notified cosmetic and its related materials such that the nature and quality intended is preserved when it reaches the consumer"   The GDP standards describe the distribution process from the manufacturing facilities to the end user,...MORE >

Top 3 Clinical Research Conferences in 2016
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Published - 15.Dec.2015
Top 3 Clinical Research Conferences in 2016

Clinical researches are changing in a lot of ways. The study environment and techniques are incorporating more and more technology-oriented trends in order to keep up with the rest of the industry. Regulations are changing, trials designs become more adaptive, strategies for clinical development optimization are shifting in attempt to be more responsive to relevant diseases, for example, and new treatment methods are tested in order to improve healthcare at rates faster than before. The most important thing, however, is...MORE >

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