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PUBLICATIONS

International Clinical Trials

ict
Spring 2018

   
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Editorís 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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REGULATORY
Clinical Trial Oversight Management

Perfecting Performance


When dealing with new revisions in the ICH  E6 (R2) guidelines, Gabriele Faist and Heike SchŲn 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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Clinical Trial Management
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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Alzheimerís Research

Improving Success Rates


Significant progress within clinical trials for Alzheimerís 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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eCLINICAL
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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CLINICAL THERAPEUTICS
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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Trial Management & Outsourcing
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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Business Practice
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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Cancer Therapeutics
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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Patient Recruitment and Retention
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 Advances
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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Published quarterly in
February, May,
August, and November

News and Press Releases

MedPharm Expands Relationship With Novan On Formulation Science

MedPharm Ltd, a leader in topical and transdermal drug delivery, has expanded its relationship with the NASDAQ listed biopharmaceutical company Novan Inc. MedPharm has previously supported Novan by testing the companyís unique formulations using its proprietary in vitro models to optimise Novanís formulations and de-risk product development.
More info >>

White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
More info >>

Industry Events

ESMO Targeted Anticancer Therapies Congress 2020

2-4 March 2020, Paris, France

A unique and international mix of experts, researchers and decision makers both from academia and industry across the globe, will convene in Paris for a three-day Congress aiming at exchanging knowledge, experience and research innovations in cancer. TAT 2020 will focus, among others, on novel strategies in immuno-oncology, personalised medicine and molecular tumour boards, preclinical studies to identify effective combination therapies, use of microbiome, tumour agnostic trials, ADC technology, oncolytics, multispecific biological constructs and targeting cytokines. Participating in TAT 2020 will offer you the possibility to take part in interdisciplinary discussions inspiring new ideas and new collaborations.
More info >>

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