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International Clinical Trials

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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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News and Press Releases

The key to tackling drug development complexity: Collaboration.

Laupheim and Ravensburg, Germany, Milford, MA, and Skokie, IL, USA, July 6, 2020 – Vetter and Rentschler Biopharma, two globally operating Contract Development and Manufacturing Organizations (CDMOs), today announced their strategic collaboration, to enhance their services and offer complementary skills and experience along the biopharmaceutical value chain. With drug development growing increasingly complex and cost-intensive, biopharmaceutical companies are under significant pressure to streamline their products’ path to market. The desired goal of the collaboration is to create long-term value through the alignment of manufacturing approaches that enable clients to bring their products to patients more easily and faster.
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White Papers

Quality of Steel

Natoli Engineering Company, Inc.

Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
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Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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