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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

SCHOTT Builds Second Melting Tank for Pharmaceutical Glass Tubing in Mainz

The international specialty glass manufacturer SCHOTT is building a second melting tank for pharmaceutical glass tubing at its main plant in Mainz, Germany. The investment volume amounts to 40 million euros. The new production facility is scheduled to go into operation in mid-2022 and will then offer 100 new jobs, 50 of which will be directly at SCHOTT. With this investment, SCHOTT is responding to the dynamically increasing global demand for glass tubing for pharmaceutical packaging.
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White Papers

Extractables and Leachables Testing: A Risk Based Approach

RSSL

Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime. Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance. Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure. This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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