International Clinical Trials |
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Editor’s Comment
Introducing this edition of ICT, Graham Hughes draws on the themes of small and medium-sized pharma – from the independent CRO scene to eClinical efficiencies for smaller sponsors – and the complex demands of supply logistics.
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Pharmacovigilance
Applied Science
UBC's Véronique Basch provides an overview of the EMA's application process for new drugs, stressing that marketing authorisation holders must be at pains to make sure that safety and regulatory documentation is properly prepared and consistent.
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Study Conduct
Talking Points
The communication flow between medical monitors and study teams is critical to ensuring ethical conduct and appropriate documentation. So it is surprising that the preferred email practices are not always up to task – as Mohamed El Malt and Vijayanand Rajendran at Europital highlight.
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Early-Stage Outsourcing
Keep It Covered
Rising development costs are prompting pharma to make the most of Phase 1 studies for data collection and compound planning. Michael Henning and Cindy Doerfler from PPD describe how bringing in CROs and using flexible umbrella designs can smooth the process.
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eClinical Models
Platform to Succeed
Integrating different eClinical applications may soon be consigned to history. Unified clinical development platforms that are built on the same underlying technology are emerging, bringing enhanced realtime data and document flows in a single workspace. Simon Wilson at ArisGlobal reports.
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Trial Master Files
Cutting a Dash
The fragmented nature of global trials calls for centralised risk-based tools to ensure Good Clinical Practice. Claire Jarmey-Swan and Peter McNaney at Phlexglobal look at how the latest dashboard metrics can help deliver complete and compliant electronic trial master files for when inspections come calling.
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R&D Collaboration
Shared Value
With growing collaboration a hallmark of today's clinical trials, stakeholders are expected to look to hybrid community clouds to enable secure and productive research, explains Exostar's Vijay Takanti.
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Reverse Logistics
Return to Sender
Despite requirements for unused drugs to be returned and accounted for, this is often considered far down the clinical trial process – raising the risk of delays, discrepancies and unexpected costs. Gavin Morgan at Packaging Coordinators, Inc calls for a rethink.
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Double-Blind Trials
The Blinding Headache
Biological compounds that require parenteral delivery are dominating the trial market, but they present difficulties when carrying out double-blinding to eliminate study bias. Biotec Services International's Martin Lamb explores the clinical supply solutions.
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Trial Logistics
Safety in Store
The modern era of global trials can create numerous logistical hurdles for clinical supplies, particularly around import and country-specific requirements. Catalent Pharma Solutions' Angus Macleod discusses how approved local depots can provide much-needed support.
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Small and Medium Pharma
Does Size Matter?
Many smaller CROs lack the confidence or resources to go up against their bigger rivals in emerging markets. But, as John Pearson at DHL Express Europe explains, an entry strategy that makes the most of the supply chain can help them gain a solid foothold.
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Diabetes and Obesity
Clamp Down
As pharma builds its armoury in the growing global battle against diabetes, Dariush Elahi and Dennis Ruff from ICON detail the glucose clamp technique used to evaluate the emerging new wave of biosimilar insulin products.
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PCT Europe: Q&A
Out and About
From disruptive innovation to the latest in strategic collaborations, the Partnerships in Clinical Trials Congress Europe is the ideal meet and greet event for clinical outsourcing, says Informa's Rosie Bernard.
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Translation Services
Do You Speak Human?
With more than 7,000 languages worldwide and a clinical R&D boom in emerging regions, translation and localisation services are very much in demand. But some predict the good times will not last, as technology forces changes in this sector. Russell Goldsmith at Audere Communications has more.
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Risk-Based Monitoring
An Eye for Change
Life sciences companies have been conditioned to perform clinical monitoring in a very ineffective manner using manual data review. Risk-based monitoring will change that, argues Medidata's Andrew Newbigging, improving research quality and cutting costs.
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mHealth Technology
Upwardly Mobile
Smartphones, tablets, apps, wearable devices – mobile technology continues to push the boundaries of life and business. ICT questions some key industry figures about its use in clinical R&D in terms of real-time data, cost, speed and accuracy.
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Human Abuse Liability Studies
Used and Abused
Clinical R&D, in the form of human abuse liability trials, has a key part to play in tackling drug abuse plaguing the US. Lorraine Rusch from Vince & Associates Clinical Research outlines this growing study area, and the challenges of recruiting recreational drug user volunteers.
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Patient Activists
Pro Active
Social media and the internet are the modern method of protest for patient activist groups opposed to trials. But, as Liz Moench at MediciGlobal explains, pharma companies on the receiving end can often turn activists into allies with an effective engagement strategy.
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Industry Interview
Thinking Allowed
Dr Mark Hooper, the new Director of translation services provider Conversis Medical, speaks to ICT about the pros and cons of local regulations and his impressions of the market so far.
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