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| home > ict > Autumn 2019 |
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 PUBLICATIONS |
International Clinical Trials |
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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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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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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 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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News and Press Releases |
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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.
More info >> |
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White Papers |
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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.
More info >> |
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Industry Events |
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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.
More info >> |
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