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International Clinical Trials

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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

A new anti-tumour treatment is one step closer to the clinic thanks to a new collaboration between In3Bio and 3P Biopharmaceuticals

[Pamplona, November 26 2019] 3P Biopharmaceuticals, a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, has been chosen by In3Bio, a UK based Biotech company, to collaborate in the development of a novel anti-tumour treatment.
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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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
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