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International Clinical Trials

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Winter 2019

   
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Clinical Trial Supply & Packaging
Adaptive Trial Designs

Redefining the Gold Standard

Detailing the process of a trial is pivotal to its success, and developing an adaptive trial can improve the outcome. However, there can be complications to this method, as demonstrated by Dr Chitra Lele and Dr Ritu Budania at Sciformix.
 
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Trial and No Error

The Evolution of Environmental Monitoring

Jukkapekka ‘JP’ Asikainen and Ossi Laakkonen at Sensire discuss the technicalities and subtleties of the technologies available to improve clinical trial supply and how best to select one. 



 
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Regional trials
Clinical Trials in Southeast Asia

Finding Future Markets

Namjoo Seo and Maree Ward at PRA Health Sciences examine Southeast Asia as a prime location for clinical trials while looking into the drawbacks of the region.
 
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THERAPEUTICS
Addressing an Epidemic

Improving Outcomes in Diabetes Research

Capturing and examining data is one of the most effective ways to understand the true number of diabetes sufferers and the associated complexities of the disease. Katie Garner at CRF Bracket explains more.
 
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Digital Advances
Developing Clinical Trial Designs with Artificial Intelligence

The Balanced Approach to Optimising Clinical Trial Design and Execution

Gen Li PhD, Paul Chew MD, and Jonathan Peachey at Phesi explore the different methods of artificial intelligence available to increase the chance of a successful trial, ultimately resulting in beneficial data.
 
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Vaccine Trials
Q&A: Pathological Rat Race

Animal Models to Study Infectious Pathogens

Carmen Sweeney PhD at Charles River spoke to ICT to provide insight into the use of cotton rats in animal models and why they could be an essential asset in fighting a wide variety of human pathogens.
 
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Features
CRA Recruitment

Specialist Shortage

Steve Lord at CK Clinical reviews future clinical research associates recruitment, how their roles are perceived in the industry, and how to encourage a career in clinical trials.
 
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Risk-Based Monitoring

Strategic Success

There are several complexities when dealing with risk-based monitoring. Patrick Hughes at CluePoints spoke to ICT to provide guidance on risk-based monitoring and how the right technology can drive it further.
 
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Automating Inventory Management in Healthcare

Automatic Improvements

Improving efficiency and accuracy is always a key target for healthcare facilities, and automation may provide the solutions for the industry. Jonathan Wilkins at EU Automation explores the available options.
 
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Helping Hearts

Concentration-QT Modelling in Early Phase Clinical Studies

With the development of new medications comes the risk of unexpected side effects. Dr Andreas Lindauer at SGS Exprimo explains how strict drug development assessment can avoid this issue.
 
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UK First-In-Human and Early Clinical Trials

Advancing Expansion

Dr Simon Hutchings at Simbec Research looks at the UK’s leading role in first-in-human clinical trials and how the experiences of each trial are enhancing the industry guidelines.
 
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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

Envigo launches PATHWAY an optimized safety assessment solution to enable first in human clinical trials

11 March 2019, East Millstone, N.J. – Envigo, a leading provider of non-clinical contract research services and research models, announced today the launch of PATHWAY – an integrated solution that optimizes non-clinical safety assessment programs to enable first-in-human clinical trials. PATHWAY is designed to manage the complexity of the entire safety assessment process on behalf of the company’s pharmaceutical and biotechnology customers by integrating safety assessment study types and bioanalytical support with scientific and regulatory consulting, program design and project management.
More info >>

White Papers

Advantages of Quantitative NMR for the Determination of Relative Response Factors

Novatia, LLC

Quantitative NMR (qNMR) is a technique that is being applied broadly and at an increasing rate in the field of pharmaceutical analysis (1). This white paper highlights the advantages of using qNMR to determine Relative Response Factors (RRFs) for pharmaceutical impurities detectable by HPLC. A single determination of RRFs using qNMR allows for simple and accurate quantitation of impurities which eliminates the need for preparation, qualification, and storage of reference standards. An example is presented here, which demonstrates quantitation of known impurities that have variable responses to UV-VIS detection, thereby providing a more accurate assessment of impurity levels than UV-VIS response alone.
More info >>

Industry Events

ASGCT 22nd Annual Meeting

29 April - 2 May 2019, Washington Hilton, Washington, D.C

The 2019 ASGCT Annual Meeting is expected to be the largest in Society history, eclipsing the mark set by the 2018 meeting just last year. Join more than 3,500 researchers, clinicians, advocates, and industry leaders in discovering the latest science and technology surrounding gene and cell therapy.
More info >>

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