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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

PCI Pharma Services Announces Bottling Line Expansion to Support Customer Needs

Philadelphia, USA – February 5, 2019 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, is pleased to announce the expansion of its bottling line capacity at its Commercial Packaging site in Rockford, IL. Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as well as in-line serialization and aggregation in support of increased customer demand. The new expansion will grow the robust bottling operation in Rockford by producing an extra 100 million bottles per year.
More info >>

White Papers

Mauritius Island – An Emerging Centre for R&D in Biotechnology and the Life Sciences

CIDP (Centre International de Développement Pharmaceutique)

Mauritius, the tropical island situated in the Indian Ocean and known worldwide for its beautiful beaches, is also internationally recognised for its rule of law, and political and social stability. Over the past few years, the economy has been successfully transitioned from a monocrop to a diversified innovation-driven and knowledge-based economy, resting on agribusiness, export-oriented manufacturing, tourism, financial services, property development and real estate, ICT-BPO, the seafood industry, a free port, logistics and a nascent ocean economy. Emerging sectors such as healthcare and life sciences are presenting some niche areas for the taking, and the enabling environment is being put in place to make it happen - especially in the light of sustained growth within pharmaceutical, medical device, and clinical research. Important international players are already in operation locally as the country has established the appropriate legal and regulatory frameworks based on international norms, for the development of a strong biomedical research sector.
More info >>

Industry Events

ASGCT 22nd Annual Meeting

29 April - 2 May 2019, Washington Hilton, Washington, D.C

The 2019 ASGCT Annual Meeting is expected to be the largest in Society history, eclipsing the mark set by the 2018 meeting just last year. Join more than 3,500 researchers, clinicians, advocates, and industry leaders in discovering the latest science and technology surrounding gene and cell therapy.
More info >>

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