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| home > ict > Spring 2018 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
ICT's Editor Dr Graham Hughes introduces the key focus topics in these editions of ICT and EPC, highlighting a number of articles.
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Clinical Trial Oversight Management
Perfecting Performance
When dealing with new revisions in the ICH E6 (R2) guidelines, Gabriele Faist and Heike Schön at LUMIS International discuss how the implementation of keyperformance indicators could be beneficial.
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Regulation Changes
Clinical Navigation
With new developments in pharmacovigilance being continually implemented, Nick Barker and Katharine Colbert at Medpace express that sponsors andmarketing authorisation holders worldwide must ensure they are prepared
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Obstacles in Cancer Research
Essential Steps
Through a Q&A, Peter Langecker, Brian Travers, and Barb Geiger at Clinipace explain to ICT the intricacies that must be considered within oncological studies.
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Alzheimer’s Research
Improving Success Rates
Significant progress within clinical trials for Alzheimer’s is being made. Dr Michael F Murphy at Worldwide Clinical Trials says new trial designsare now addressing previous research challenges.
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Spotlight
York Health Economics Consortium
York Health Economics Consortium is a health economics consulting company owned by the University of York. It provides a range of services,including economic modelling, literature searching, systematic reviews,
network meta-analyses, outcomes research, and applied research and training to the NHS and the pharmaceutical and healthcare industries |
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Oncology Trial Validity
Imaging Innovations
Working alongside effective site training, today's imaging analysis technology could bring improvements to the quality, timeline, and cost of oncology trials. Sophie Winandy at ERT explores how.
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eClinical Improvements
A New Pathway
Jeff Lee at Bracket details the ways in which technological approaches alongside unified thinking can enhance patient engagement, becominga key asset within clinical research.
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EMA First-in-Human Guidance
Exponential Developments
As regulations for first-in-human trials progress, Bradley Joblin at Q-Pharm examines the new considerationsthat must be made within early phase development.
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The Sponsor/Vendor Relationship
Key Relations
Shanelle Mehta at The Clinigen Group explores how outsourcing is becoming common practice within the pharmaceutical and biotechnology industries, thereby creating a good sponsor/vendor relationship and a reliable process.
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End Point
Public Perception
ICT Editor Dr Graham Hughes considers the role of clinical trials and how they are
publicly perceived
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Oncology Clinical Trials
Optimising Outcomes
Routine cancer care can be enhanced by integrating electronic patient-reported outcomes and clinical outcome assessments. Katie Garner at CRF Health examines how.
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The Patient Experience
The Engagement Equation
Modern clinical trials rely on patient engagement. Aaron Fleishman and Sarah Mandracchia at BBK Worldwide analyse the new tools and techniques that must be utilised to ensure all trial stages are successful.
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Digital and Cloud Developments
Revolution or Evolution?
As the industry begins to embrace new clinical methods, David Goldston at Veracity Logic considers how it disrupts conventional, long-standing trial management.
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News and Press Releases |
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Novo Nordisk to Acquire Emisphere Technologies for $1.35 Billion
ROSELAND, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Emisphere Technologies, Inc. (“Emisphere” or the “Company”) today announced that it has entered into a definitive agreement with Novo Nordisk A/S (“Novo Nordisk”), whereby Novo Nordisk will acquire Emisphere, on a cash-free, debt-free basis, for $1.35 billion in cash. The consideration to be paid per share will depend on the amount of cash and debt at closing, but the Company currently estimates it to be approximately $7.82 per share based on approximately 170.9 million fully diluted shares outstanding. This price represents a premium of approximately 17% over the volume-weighted average Emisphere share price for the five trading days ending on November 5, 2020.
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White Papers |
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A Rules Based Approach to Labelling and Artwork Management
Kallik
Many organisations today are experiencing unprecedented demands from regulatory authorities and consumers alike for product labelling to be made clearer and more informative. Forthcoming regulations (including the new EU MDR regulations coming into force May 2020) also require that labelling content to be published electronically in addition to print. As companies seek to continuously differentiate themselves in established markets as well as gain entry into new territories, the increase in both volume and complexity of product and market variations will have a direct impact on labelling.
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