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PUBLICATIONS

International Clinical Trials

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Autumn 2014

   
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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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Regulatory & Business Practice
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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TRIAL MANAGEMENT
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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Clinical Trial Outsourcing
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
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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Clinical Trial Supply & Packaging
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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CLINICAL THERAPEUTICS
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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PREVIEW
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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Regional trials
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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data management & statistical analysis
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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Trial Design
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 Recruitment and Retention
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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Interview
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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
More info >>

White Papers

What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
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Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
More info >>

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