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PUBLICATIONS

International Clinical Trials

ict
Winter 2011
   
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Regulatory & Business Practice
Mian Atif Saeed at Bristol-Myers Squibb argues that, although complex and lengthy, the drug development process has plenty of scope for changes to its usual framework that could help it become more streamlined, leaner and efficient.
 
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The huge cost to a project should it fail to meet compliance requirements compels imaging core labs to pay heed to 21 CFR Part 11. However, as Christian Teague at RadCore Labs, LLC and FDA Compliance Specialist David Nettleton point out, this can be seen as a positive step.
 
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Based on the principles of value management, Paul Naybour and Roger Joby at Parallel Project Training propose a collaborative approach to drug development feasibility studies, bringing the whole project team together to understand challenges and identify significant cost reduction strategies.
 
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TRIAL MANAGEMENT
Although randomised controlled trials provide more benefits than observational studies, the latter is becoming more common and therefore their statistical challenges need to be addressed. David J Pasta and Dave P Miller at ICON Clinical Research discuss two techniques that can be used to address group differences in these studies.  
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The cost of conducting early phase oncology studies has increased substantially over the last decade. However, the future holds the prospect of technological advances and trial management tools that can be used to reduce the expenses incurred, explains Kim Boericke at i3.  
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Michael Rosenberg of Health Decisions, Inc discusses how the combined use of adaptive operations, adaptive designs and supporting technologies can enable the pharma industry to break the efficiency barrier and rise above its own limitations.  
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Susan Suchdev of IRW Consulting considers the questions that investigators ask themselves during clinical research about quality, risk assessment, patient recruitment and site selection, and summarises seven critical steps for clinical study success.  
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Regional trials
Emerging regions feature increasingly in the list of top countries where clinical trials are being performed. Looking at Turkey, Karen I Politis Virk at Language Connections assesses the linguistic and regulatory challenges one should consider before outsourcing clinical research to this market.  
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Jörg Taubel, Keith Berelowitzand Ulrike Lorch at Richmond Pharmacology Limited make a case for conducting early phase clinical research in the UK over other European countries, and identify opportunities available for pharma companies and CROs alike.  
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Interactive voice response systems have evolved beyond the telephone to provide a variety of solutions, from web-based randomisation to sophisticated drug supply monitoring. Charles Gasman at PharmaNet Development Group discusses the role these systems will play in future clinical trials.  
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As the search for patients leads to an increased globalisation of trials, Hugh P Levaux and Jaime Lau at UBC consider how interactive voice or web response systems can optimise the clinical trial process and ease the integration of global economies, such as Asia, into the market.  
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Valdo Arnera of PHT Corporation makes a case for automating the collection of patient reported outcome data as a way to achieve regulatory compliance and ensure patient safety, while also enabling eClinical trials that are less expensive, more accurate and safer than paper-based research.  
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THERAPEUTICS
DEXA technology has had an enormous impact on the measurement of bone densitometry in the last 50 years, and will continue to provide an essential resource for organisations conducting clinical trials, as shown by Annelee Spano Lander at CoreLab Partners and independent consultant Reta C Rupich.
 
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Paola Antonini and Michael F Murphy at Worldwide Clinical Trials examine trials in emergency departments, and assess the challenges that researchers face when conducting studies in this unpredictable workplace.
 
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Supply Chain & Manufacturing
Biological products are tricky to transport, but with the right packaging and logistics methods in place, problems can be overcome and savings achieved, as Rachel Griffiths at Biotec Services International explains.
 
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Peter Soelkner at Vetter Pharma International asks if it is sensible to partner in the early clinical development period, and if so, what the drug developer should look for in a potential contract manufacturer.
 
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Central Labs
Patrice Hugo at Clearstone Central Laboratories makes the case for centralised laboratories over decentralised,pointing to their flexibility and ability to combine all parties’needs, as well as identifying key trends that will affect these labs in the near future.
 
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Green initiatives in the laboratory are important not only to minimise any impact on the environment, but they also have implications in terms of safety and cost reduction, as highlighted by Tim Hynes at DaVita Clinical Research.
 
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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

West Announces Official Opening of Expanded Kiefernweg Campus and New Center of Excellence for Innovation and Technology in Eschweiler, Germany

West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, today officially opened the Company’s recently expanded Kiefernweg Campus in Eschweiler, Germany, which includes a new global center of excellence for the research and development of pharmaceutical packaging components and systems for injectable medicines.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

Cell Therapy Manufacturing & Gene Therapy Congress

6-7 December 2017, RAI, Amsterdam

Bringing together 300+ leaders and key influencers from pharma and biotech companies on 6 - 7 December 2017 in Amsterdam, Cell Therapy Manufacturing & Gene Therapy Congress will provide you with the latest advice for driving manufacturing and commercialisation through direct access to transforming innovative research to prosperous cell & gene manufacturing.
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