International Clinical Trials |
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Regulatory Update: Medical Devices
Under the Environmental Microscope
Matthew Townsend and José Cofré at Allen & Overy LLP highlight the key changes in the revised Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive, describing how they will affect the medical devices sector.
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Personalised Medicine
Pipeline Potential
Put simply, the aim of personalised medicine is to get the right drug to the right patient.This depends on our ability to match our growing understanding of disease biology with the identification of suitable therapies, which in turn should be matched to the relevant patient, explains James Sawyer of Prism Ideas.
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Monoclonal Antibodies
Flow Cytometry and Clinical Trials
Carla G Hill and Thomas W McCloskey of ICON Central Laboratories provide an insight into the future of medicine, and how a combination of small and large molecule compound therapies, cellular biomarkers and flow cytometry will play a role in clinical development.
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Event Preview
Five Shows, One Vision
CPhI Worldwide, ICSE, InnoPack, BioPh and P-MEC Europe will take place at the popular Messe Frankfurt exhibition centre in Germany, from 25th to 27th October 2011.
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Data Centre in China
Tales from the City
You might think that if you know how to conduct clinical trials in one country, you’ll also have success in another.However, Bruce D Schatzman of StudyManager explains that even with vast experience and technical knowledge, some challenges will simply not be anticipated.
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Translation in Africa
Speaking the Language
According to Unesco, around 2,000 different languages are spoken in Africa; however, there is a shortage of translators, which can make clinical trials on the continent challenging. Simon Andriesen at MediLingua investigates how CROs and international organisations are dealing with this problem.
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Logistics in the Middle East
Safely Does It
The Middle East is a region that poses a number of operational challenges.However, packaging manufacturers must rise to the challenge of creating operational bases to ensure the safe delivery of clinical trials materials, as Steve Healy and Karen Adams from SCA Cool Logistics report.
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Digital Pens and Paper Technology
Data Dynamics
Despite the rise of electronic applications, a large amount of clinical trial data is still being collected using paper-based methods.However, digital pen and paper (DPP) is now being adopted as a user-friendly and more accurate alternative, as Petter Ericson at Anoto AB explains.
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Interim Analyses
The Profitable Pause
David Underwood at Quanticate demonstrates how the Bayesian statistical framework can be used to plan and execute interim analyses – a process that is useful in making decisions about continuation versus early stopping of clinical trials – thereby improving the likelihood of success.
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Data Mining
Drilling Down to Success
Combining systematic analysis using data mining technologies with the critical insight of clinicians will help to increase success rates and diminish risk in clinical trials, as Mohammad Afshar and Lilia Abtroun of Ariana Pharma elaborate.
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Subject Payment Systems
Put it on the Card
A cost-effective method of payment to clinical trial participants can significantly improve subject retention rates – particularly when faced with the microwave mentality of ‘want it fast,want it now’. Samuel Whitaker at Greenphire discusses how new web-based payment solutions can help.
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Telemedicine Technologies
Moving Data, Not Patients
Significant savings and efficiencies can be achieved by implementing an electronic interface between the sponsor, investigator and patient. Erik J Fransen of Vitaphone Telemedicine explains the benefits that can be accrued in this relatively unexplored area of clinical trials.
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eCRFs
Promises, Promises
Despite the potential of eCRF, the platform can increase costs and make clinical research management more complex if not applied properly. Andrea DeRosa of Airon Telematica (Air-Tel) stresses that professionals will need to let go of old procedures and embrace new technologies in order to see significant benefits.
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Central Labs: Data Management
Entering the Atomic Age
Hacene Mekerri of Clearstone Central Laboratories examines the different phases in the evolution of data exchange and flow, envisioning a future which allows data managers, aided by the most sophisticated applications, to focus their time on the bigger picture.
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Central Labs: New Technologies
Seamless Integration
In the past 15 years, data produced by centralised laboratories has represented more than 60 per cent of all data submitted in new drug applications, and this percentage is expected to approach 80 per cent within the next few years. John Blakeley of ERT discusses the future of centralisation with a particular focus on cardiac safety.
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Translational Science
New Saviour
Simon Beaulah, Paul Denny-Gouldson and Robin Munro of IDBS describe how opportunities for successful collaborations between academia and industry partners in stratified medicine research can be greatly enhanced with the use of collaborative research platforms.
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Risk Management
Right Place, Right Time
In the increasing complex world of clinical trials, incorrect management of risk can have severely detrimental effects on the entire study.Active risk management is important in order to achieve cost-effective and better quality results explains Guy Patrick of Centrical Global Limited.
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Investigator Site Training
Synchronised Learning
Brendan Buckley at Firecrest Clinical argues that the current design of a typical investigator meeting is not conducive to interactive learning, suggesting that a hybrid model of training via shorter, regional and more principal investigator-focused meetings is a much better way to learn.
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Book Review
The Ethical Code
Graham Hughes reviews On Moral Grounds: Lessons from the History of Research Ethics by Allen Gaw and Michael HJ Burns.
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