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Autumn 2019

   
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Features
Social Media in Orphan Disease Research

The New Imperative

Barbara Zupancic at Worldwide Clinical Trials evaluates the revolution of social media in clinical research and its newfound importance to the recruitment of rare and orphan disease subjects.
 
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Spotlight

A Landmark for Life Science Professionals

DIA Europe 2020 will be taking place in Brussels, bringing you expert insights into new trends and innovations in technology and research, with the patient perspective at the forefront of clinical research.
 
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Spotlight

The Spirit of Radical Integration

The Avoca Group is dedicated to enhancing the quality of clinical trial processes, mitigating risks, and providing innovative solutions by bringing together industry experts with their Quality Consortium.
 
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Clinical Trial Recruitment in Asia Pacific

The Pacific Rim

Dr Tracy Goeken at Linical Accelovance Group examines the benefits of conducting clinical trials in Asia Pacific, utilising its vast patient population and seeking to resolve the challenges of patient recruitment and retention.
 
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Therapeutic Focus: Dementia
Patient Registries in Dementia Trials

Early Detection for Invisible Patients

Professor Clive Ballard at the University of Exeter Medical School and Dr Dawie Wessels at Accelerated Enrollment Solutions discuss how patient registries can improve the detection of ‘invisible’ patients for dementia trials, presenting a new opportunity for prevention.
 
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Response Rates in Dementia Research

The Burden of Time

Minimising participant burden is essential to all medical research, and Shani McCoy at Berkshire Healthcare Foundation Trust assesses the factors that contribute to patient burden in dementia studies.
 
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New Frontiers in Alzheimer’s Disease Research

The Practical Alternative

The failures of Alzheimer’s disease research have opened up new approaches to achieve an earlier diagnosis and a more effective treatment approach, argues Timothy Earle at TauRx Theraputics.
 
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Innovative Trial Design
Guidance for Rare Disease Research

The Formula for Success

Dr Pavle Vukojevic, Dr Milan Marinkov, and Dr Jovana Vlajkovic- Josic at Pharm-Olam present a formula for success in improving recruitment, the accuracy of data, and streamlining rare disease clinical trials.
 
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Q&A: Clinical Trial Management Systems

Software Solutions

In a conversation with ICT, Ricky Lakhani at PHARMASEAL answers questions about the upcoming trends, benefits, and challenges in designing an effective trial management system using cloud-based software.
 
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Risk-Based Monitoring
Risk-Based Monitoring and Real-World Data

A Decentralised Ecosystem

There is an appetite for change in the capture, integration, and analysis of valuable data from human subjects, and Ian O’Shaughnessy at ICON explores the synergies between risk-based monitoring, decentralised clinical trials, and eSource.
 
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Clinical Data Management and Quality

A Paradigm Shift in Data Monitoring

François Torche at CluePoints examines the impact of regulations on data quality and management, addressing the need for more optimised monitoring approaches in clinical data science.
 
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Beyond Analytical Dashboards Without Context

Learning to Fish in Data Lakes

For Craig Morgan at Oracle Health Sciences, companies should seek new technology solutions for data monitoring, making effective use of analytical dashboards for powerful insights.
 
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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

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

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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