International Clinical Trials |
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Editor’s Comment
Despite the burden and complexity of adverse event reporting, Graham Hughes considers whether the industry is doing enough in this area.
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Pharmacovigilance
A Safer Europe
Despite the benefits of modern medicines, there is mounting evidence of the dangers too, in the form of adverse reactions. Mieke Notenbaert at Emtex outlines the rigorous drug safety measures that have evolved, including the latest European legislation. |
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Adaptive Designs
Dose of Reality
Vladimir Dragalin at Aptiv Solutions explores how the use of adaptive designs in dose-ranging studies can improve our ability to effi ciently learn about the dose response and better determine whether to take a drug forward.
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Trial Management Systems
Death of CTMS?
The potential demise of clinical trial management systems has been greatly exaggerated. They may have earned a bad reputation in the past but, says Simon Wilson at ArisGlobal, a new generation of these systems has much to offer clinical operations teams.
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Site Equipment
Kitted Out?
Equipment supply to investigator sites is ever-more critical. Pierre Malingrey of Quipment offers some tips on the logistical and information issues – from tracking items to contract options – that should be considered early in the study design process.
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Outsourcing Models
Starting Point
Under pressure to do more with less, many small- to mid-sized pharma companies are asking whether it is better to set up a pharmacovigilance department in-house or outsource it. Donelle Bussom from ICON Clinical Research compares the options. |
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e-Patient Update
Digital Connectors
With e-Patients demanding and sharing more and more health-related information online, Pete Chan at Tudor Reilly Health assesses the industry implications and sees an opportunity to drive public awareness and recruitment of trials. |
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Operational Software
Reach for the Sky
Early concerns about
the open nature of cloud-based software initially slowed its adoption by pharma
but, as Jen Goldsmith at Veeva Systems explains, the benefits in terms of
document workflows and broader efficiencies are now an exciting prospect. |
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Investigator Site Files
Electronic Edge
As the industry
continues to go electronic, paper-based investigator site files are inevitably
giving way to eISFs. Phlexglobal’s Gillian Gittens argues that the process and
compliance improvements are significant, but so too are the obstacles to
implementation. |
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Product Labelling
Multiple Choice
Frank Jäger and Nurdan Citamak at Faubel examine how labels once used as secondary packaging for investigational products are now multifunctional tools that convey variable data in different languages and help ensure safe and userfriendly products. |
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Clinical Supply Data
Mind Your Language
Prompted by industry-wide inconsistencies in managing local language data, PRISYM ID’s Vince Postill calls for a more integrated and country-specific approach to label and booklet design. |
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PCT Congress Q&A
Customer First
Trudie Lobban, a keynote speaker at the upcoming Partnerships in Clinical Trials Congress, considers how better patient involvement would help overcome fears about the industry.
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Eastern Europe
Ukraine Calling
Ukraine is currently in the ‘sweet spot’ between emerging on the scene and being saturated with trials. Pavle Vukojevic and Oleksandr Iaroshkevych of Pharm-Olam International take a look at this former Soviet republic now edging towards the European Union. |
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Regional Focus
CEE for Yourself
With studies in Central and Eastern Europe more than tripling over the past five years, the need to fully understand the region’s varying dynamics is critical. Marcin Ernst and Cristina Stefanescu at INC Research give the lowdown. |
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African Infrastructure
Continental Shift
The growing attention on Africa as an investment destination, and increasing talk about the continent as an economic force, unveils tremendous opportunities for R&D pioneers. Marieme Ba, Suemyya Warrak and Beatrice Coly at Pharmalys report.
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Rare Diseases
Changing Lives
With more rare diseases being discovered each year, a dramatic rise in orphan drug development is taking place. Rani Abraham and Rabinder Buttar of ClinTec International predict the trial potential of the Middle East and North Africa as the industry plays catch up.
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Risk-Based Monitoring
Under Surveillance
The increasing importance of central statistical surveillance is indicative of the crucial role of statistics and programming in effective clinical trial monitoring. Chitra Lele and Samyuktha Ajay at Sciformix evaluate this risk-based approach.
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Data Collection
People Power
Timely, well-planned communication and education goes a long way in helping investigator site staff overcome the growing technology burden stemming from electronic data capture. Caroline Chin and Chuck Johnston from AXON Communications report.
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Information Management
Content is King
Managing the core information and regulatory data assets of a company has become a complex and risky business, raising the need for more sophisticated content-centric solutions, advises Satish Tadikonda at Virtify, Inc.
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Business Insight
Look Local
The intricacies of running successful trials in Central and South Eastern Europe are outlined by Takis Zervakakis of Zeincro.
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Industry Interview
Thinking Allowed
Myoderm’s Michael Cohen talks to ICT about the surge in demand for comparator drugs, and the big sourcing and supply issues ahead.
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