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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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Editor’s 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 Patient’s 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 – 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 – 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 organisation’s 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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Published quarterly in
February, May,
August, and November

News and Press Releases

Thermo Fisher Scientific Collaborates with Artificial to Enhance COVID-19 Diagnostic Testing Solution

TORONTO, Canada – (March 23, 2021) – Thermo Fisher Scientific, the world leader in serving science, and Artificial, developers of flexible automation software, have announced a strategic technology collaboration to develop an integrated and comprehensive software automation platform for Thermo Fisher’s standardized COVID-19 Testing Platform. The integration will result in increased testing throughput and support global healthcare initiatives.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

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