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International Clinical Trials

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Summer 2012
   
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Regulatory & Business Practice
Prescription Drug User Fee Act

Navigating the Initiatives

Nina Baluja, George R Hemsworth, Mehri Hezari-Adam, Pat Mann and Henrietta Ukwu at PPD explain how the changes in the Prescription Drug User Fee Act will affect pharmaceutical and biotechnology companies in terms of cost and timeframes.
 
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Clinical Research Training

Raising the Bar

Precise training strategies help to ensure that clinical research professionals are equipped to perform well in the workplace, explains Martin Robinson at the International Academy of Clinical Research.

 
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PREVIEW

Partnerships in Clinical Trials Europe

Adapting to Change

Learn about strategic and practical approaches to enhancing relationships between trial sponsors and their suppliers at this upcoming event in November.
 
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Industry Interview: Lotus Labs

The Road to Madrid

Dr Yati Chugh talks to ICT about the clinical research scene in India, and what he is looking forward to at ICSE.
 
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Showcase: ICSE

Event Preview Ready for Business?

Get ready to network and learn at the ICSE event in Feria de Madrid, taking place in October.
 
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Editorís Comment

Graham Hughes notes how the clinical trials world is increasingly patient-centric in its approach.
 
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Regional trials
Regional Trials: India

Shining Light

Apurva Shah at Veeda Clinical Research and Ashish Kumar Dasgupta of the Association of Contract Research Organizations discuss how revisions to regulatory processes in India are transforming the appeal of conducting clinical trials in the subcontinent.
 
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Regional Trials: China

Betting Big

As China becomes an increasingly important player in the pharma industry, Nick Stephens of RSA speculates on the changes that will occur in terms of R&D.
 
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Patient-Centric Trials

Drug Development 2.0

Tomasz Sablinski of Transparency Life Sciences investigates new trial design elements that are shaping the future of drug development, including crowdsourcing, data transparency and telemedicine.
 
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Mobile Technology

Capturing the Patientís Voice

Judith Teall at Exco InTouch explains how mobile technology is driving a more patient-centric approach to late phase research.
 
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Measurement-Based Care

The Patient as an Individual

Stephen Webb at REGISTRAT-MAPI North America shares his thoughts on the developments that are occurring in the healthcare industry and examines whether measurement-based care can improve outcomes for patients and reduce costs.
 
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Serious Adverse Events Reporting

Safely Does It

Knowledge regarding serious adverse events is crucial in the process of clinical development. Rick Morrison at Comprehend Systems describes how new data visualisation and statistical analysis software can improve the accuracy of reporting
 
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Monitoring Data Management

Doing More with Less

Richard Young at Medidata Solutions delves into risk-based monitoring Ė an area that is being changed and modernised through a series of new technological breakthroughs.
 
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Statistical Analysis

Non-Response: Issue or Inconvenience?

Missing data may pose a problem for those carrying out clinical trials, but as Andrew Grannell at Statistical Solutions explains, non-response may actually be able to contribute additional information to studies.
 
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Labs & Logistics

Logistics: South America

Right Place, Right Time

Angus Macleod at Catalent Pharma Solutions assesses the importance of taking the differences in regional regulations into account when importing clinical trial materials.
 
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Partnering with Central Labs, ECG and Imaging Labs


Outsourcing Strategies

Graham Hughes reports from
Partnering with Central Labs, ECG and Imaging Labs Ė an Informa Life Sciences Conference held in Brussels.
 
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Global Sample Management Benchmarking Symposium

Strategic Sample Management

Graham Hughes provides a round-up from an information-packed symposium that was organised by Biostorage Technologies, and sponsored by ICT.



 
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Reviews
Graham Hughes reviews Principles and Practice of Clinical Research: Third Edition, edited by John I Gallin and Frederick P Ognibene.
 
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Patient Recruitment and Retention
Study Recruitment: Social Media Feasibility Model

Status Update

The trend for using social media platforms to recruit patients for clinical trials is on the rise. Before embarking on this approach, Rahlyn Gossen at Rebar Interactive outlines the importance of a feasibility model, based on an assessment of the patient, the organisationís ability, and the budget available
 
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Patient Engagement

Bring it Online

Finding ways to actively engage the patient in a clinical trial has proved to be far from straightforward exercise. Aaron B Fleishman at BBK Worldwide shows how social media tools can be employed to raise awareness of the science behind the clinical research.
 
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Interview
Industry Interview: Thinking Allowed

Maria V Lopez-Bresnahan of PharmaNet/i3 talks to ICT about her clinical trials experience, and what the future holds for the industry.

 
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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

Denny Bros Group continues its support of Packaging Innovations

A world leading print company is preparing to showcase its renowned labelling and printing solutions at next monthís prestigious Packaging Innovations show.
More info >>

White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

Industry Events

Clinical Trial Supply New England 2018

7-8 March 2018, Boston, MA, USA

Clinical Trial Supply New England has now reached its 7th birthday! For the 7th annual Clinical Trial Supply New England 2018 conference, we have speakers who will focus primarily on discussing case studies, drawing from their own experiences to share the highs and lows for you to adopt in your trials.
More info >>

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