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| home > ict > Autumn 2017 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
Dr Graham Hughes, Editor of ICT, takes a look at some of the key discussion points of this issue, touching on the Internet of Everything, the development of medical devices and the recently instigated EU directives.
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European Focus
Restricting Regulations
Rules and regulations often slowdown clinical trial practices, affecting the processing time between thelaboratory and the consumer. Craig Morgan at goBalto asks whether there is anyopportunity for change in Europe.
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Mental Health Research
A New Horizon
With mental health often overlooked, Professor Kathryn Abel at NIHR examines new, low-cost methods that could help clinical studies in this particular field.
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Managing Cell and Gene Therapies
Perfect Planning
As the worldwide market for regenerative medicines continues to grow, Lisa Vocat at World Courier talks about the logistical challenges now faced when developing new drugs for this therapeutic area.
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Trials in Pneumonia
Problematic Patterns
The team at PSI CRO discuss how distinguishing trends followed by serious adverse effects is vital when large amounts of new antibiotics are being tested for community acquired pneumonia.
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Unifying Operations
Better Together
Rik Van Mol at Veeva Systems believes the answer to questions surrounding streamlining clinical systems is industry-wide operational continuity.
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Serialisation Beyond Compliance
Keeping Track
Serialisation is an essential factor in maintaining compliance, but Steve Wood at Covectra notes its potential in other areas, such as anti-counterfeiting and delivery to end-users.
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Mobile Services
Closer to Home
The incorporation of mobile units within patient recruitment can improve retention and enrolment rates. Lindsey Copeland and Diane Campbell at CK Aspire discuss the impact this has on clinical trials.
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Translation and Local Knowledge
In Other Words
Gary Muddyman at Conversis analyses the complex undertaking of communicating messages to a global audience, highlighting the importance of tailoring your content and ensuring quality of data.
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Q&A: Adapting to New Regulations
Hindering Hazards
Patrick Hughes at CluePoints explains the impact of new regulatory updates in trial quality maintenance, specifically covering ICH E6 R2, and how pharma companies can handle this shift.
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IoE in Clinical Trails
Superior Strategy
CRF Health’s Richard Strobridge reflects on how the Internet of Everything could positively impact healthcare in terms of improved patient experience and focus within clinical trials.
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Wearable Technology
Fastening Pharmaceuticals
Jeremy Wheeler at Quanticate reviews the noticeable benefits that incorporating wearable medical devices may have or pharma companies trying to bring new medicines to the market.
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New Developments in Patient Outcomes
Technological Takeover
IBM Watson Health’s Jeff Beeler and Alysa Lesemann consider how patient-reported outcomes, alongside new technological reporting methods, can provide guidance
when developing new drugs.
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Compliant Packaging
Handle with Care
The shipping of biological substances across borders needs to be rigorously regulated, so Sue Fletcher at Alpha Laboratories Ltd discusses the importance of complying with UN3373.
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End Point
A Costly Cause
Looking to the future of clinical trials, ICT editor Dr Graham Hughes emphasises the worrisome impact of the expensive development of precision medicines.
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News and Press Releases |
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PCI Announces Expansion of its Industry-Leading Cold Chain Infrastructure with Dedicated Minus 40 degrees C Facility
Philadelphia, USA – August 29, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, Clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce the completion of a purpose built -40°C storage and distribution facility at its North American Clinical Services Center of Excellence.
More info >> |
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White Papers |
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Pharmacovigilance and Risk Management Information in Centralised Applications in the EU
United BioSource Corporation (UBC)
Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Industry Events |
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10th Annual Summit for Clinical Ops Executives
18-21 February 2019, Hyatt Regency Orlando, Florida
Celebrating its 10th successful year, SCOPE Summit 2019 takes place
February 18-21 in Orlando, FL. Over the course of four stimulating days of
in-depth discussions in 19 different conferences, 3 plenary keynote sessions,
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, including...
More info >> |
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