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home > ict > Spring 2018
PUBLICATIONS

International Clinical Trials

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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

3P Biopharmaceuticals receives FDA approval

[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >>

White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drugís efficacy if not applied correctly according to regulatorsí interpretation.
More info >>

Industry Events

SCOPE Summit for Clinical Ops Executives

18-21 February 2020, Hyatt Regency, Orlando, Florida, US

Celebrating its 11th successful year, SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, 3 plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations
More info >>

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