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International Clinical Trials

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Autumn 2017

   
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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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Regulatory & Business Practice
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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Clinical Trial Management
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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Drug delivery & Therapeutics
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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Patient Recruitment and Retention
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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Interview
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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Digital Advances
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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

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.
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White Papers

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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

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...
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