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PUBLICATIONS

International Clinical Trials

ict
Spring 2018

   
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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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REGULATORY
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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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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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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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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging

Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >>

White Papers

PROTEIN:PROTEIN INTERACTION ANALYSIS

IBA GmbH

Groth et al., 2007 and Jasencakova et al., 2010 Protein:protein-interactions (PPI) govern almost all important processes in living organisms. Thus, their rapid and accurate determination and investigation is a major challenge in life sciences. The extremely efficient and fast One-STrEP (Twin-Strep) system is suitable for the isolation of functional protein complexes and subsequent mass spectrometry analysis leads to the identification of protein complex components (Junttila et al., 2005) as it is shown in the following studies.
More info >>

Industry Events

PDA Parenteral Packaging 2019

19-20 March 2019, Hilton Molino Stucky, Venice, Italy

PDA Europe’s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Venice in March 2019 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and cont­ainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.
More info >>

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