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International Clinical Trials

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Summer 2016

   
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Editor's Comment

ICT Editor Graham Hughes introduces the issue by highlighting this quarter’s main themes, including eClinical advances, pharmacovigilance and patient engagement.

 
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Regulatory & Business Practice
FDA Investigations

Safety Warning


Due to the increasing importance of pharmacovigilance in drug development, the FDA has begun to conduct more rigorous inspections – leading to some companies receiving a warning letter. Sciformix Corporation’s Dr Mitchell Gandelman discusses how best to avoid these.

 
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Pharmacovigilance Update

New FDA Guidance: Impact on Clinical Safety Data


Suspected adverse events have come under growing scrutiny by the FDA, observe NDA Group’s Dr Brian Edwards and Olga Björklund, and emphasise that staying fully up-todate with regulations is the only way to remain compliant.


 
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Clinical Trial Management
Clinical Trial Efficiency

How-To Guide

Craig Morgan
at goBalto laments the fact that SOPs are still not utilised to their full potential in clinical trial start-ups, despite their positive impact on budgets, timelines and clinical trial efficiency in general.

 
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Risk-Based Monitoring

Embrace Change

Small- and medium-sized enterprises have not yet adopted a risk-based monitoring model despite its cost- and quality-associated benefits, observe Abby Abraham at Algorics and Eric Jacobson at MedNet Solutions. What can be done to encourage implementation?

 
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eCLINICAL
eClinical Advances

Capture the Data


In light of the rapid transition from paper-based to electronic workflows, Marc Desgrousilliers and Eric Morrie at ClinCapture give an overview of the current eClinical technology available to the pharmaceutical industry.

 
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Digital Trials

Transformed Reality


Appian’s Evjatar Cohen
examines how quality in electronic clinical trials can be maintained – and both mobility and collaboration seem to be key aspects in driving a digital transformation forward.

 
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MARKETPLACE
Biosimilar Development

Growth Spurt


The increasing demand in biosimilars – cheaper versions of authorised drugs – is leading emerging countries to start looking into heavier investment. Rajveer Singh Rathor at MarketsandMarkets reports.

 
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End Point

Brexit Implications

Now that the UK has voted to leave the EU, Graham Hughes comments on potential outcomes of Brexit for the pharma industry.

 
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Ethics & Risk Management
Feasiblity Assessment

Why Risk It?


Poor risk management is a real cause of concern for pharma, says Centrical Global’s Dr Guy Patrick. Having proven risk management plans in place may help to avoid negative outcomes in patients, products and studies.

 
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Supply Chain & Manufacturing
Cold Chain Management

Under Control

Pelican BioThermal’s Kevin Lawler
looks at what temperature-controlled packaging manufacturers are doing in terms of mitigating cold chain risks to address the demands of an evolving clinical landscape.

 
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Patient Recruitment and Retention
Patient Motivation

Soothing Recruitment and Retention Headaches the Logistical Way


Keeping subjects motivated during a study is anything but simple. EQ Travel’s Franc Jeffrey explores some of the reasons why and proposes the involvement of a travel management company as a solution.

 
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Electronic Patient Recruitment

Pick and Choose


The process of enrolling suitable patients in a study is, at best, cost- and time-intensive, leading to heightened risk in the development of drugs. Tigran Arzumanov, Bernhard Bodenmann and Le Vin Chin at Clinerion investigate whether recent advances in data analytics could facilitate his search.

 
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Patient Engagement Technologies

Customer Loyalty


Recent technological advances in patient retention have failed to take into account two other major stakeholders, states Dr Chris Watson at Exco InTouch, who further explains what sponsors and CROs stand to gain from implementation of these developments.

 
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Interview
Q&A: Cloud-Based Solutions

Stronger Through Collaboration

Anne Zielinski
at Bioclinica eHealth Solutions talks to ICT about their recent partnership with ARISGlobal, designed to pool resources and strengthen both businesses’ portfolios.

 
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Company Q&A

Logistical Challenges of Tomorrow


ICT questions Volker Kirchner at World Courier about the company’s dedication to serving the temperaturecontrolled needs of the pharma industry, and the reasons behind their success.

 
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Q&A: Electronic Data Acquisition

Tipping Point

Dr Michael Murphy
at Worldwide Clinical Trials investigates the use of technology in trials, and the effect this has on clinical operations as a whole.

 
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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

CPhI Worldwide report highlights unpredictability in CDMO growth over next 5-years


More info >>

White Papers

Bio/Pharmaceutical Methods: Do your Analytical Methods Hold Up to Regulatory Scrutiny?

Eurofins BioPharma Product Testing

As FDA guidelines evolve and drug products on the market begin to age, bio/pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe. This exercise requires significant amounts of time and resources, which many manufacturers do not have since they are focused on getting their next products to market. For that reason, some clients have been turning to Eurofins Lancaster Laboratories for support.
More info >>

Industry Events

LogiMed 2017

18-19 October 2017, Hyperion Hotel, Hamburg

Taking place 18-19th October in Hamburg, LogiMed is Europe’s only dedicated medical device supply chain event bringing together over 150 Medical Device Supply Chain Professionals to network with. With a greater focus on customer collaboration and digital transformation this year’s LogiMed delivers real insights on inventory visibility, supply chain planning, global logistics and digitalization.
More info >>

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