samedan logo
 
 
spacer
home > ict > Summer 2016
PUBLICATIONS

International Clinical Trials

ict
Summer 2016

   
Text
PDF
Editor's Comment

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

 
view
download pdf
bullet
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.

 
view
download pdf
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.


 
view
download pdf
bullet
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.

 
view
download pdf
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?

 
view
download pdf
bullet
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.

 
view
download pdf
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.

 
view
download pdf
bullet
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.

 
view
download pdf
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.

 
view
download pdf
bullet
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.

 
view
download pdf
bullet
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.

 
view
download pdf

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.

 
view
download pdf
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.

 
view
download pdf
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.

 
view
download pdf

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.

 
view
download pdf
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.

 
view
download pdf
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.

 
view
download pdf
   
spacer
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

York Health Economics Consortium offers a new health utilities training course

Cost-utility analysis is a requirement for NICE health technology appraisals and is being increasingly used in other contexts and countries. Health utilities, a crucial component of cost-utility analysis, capture the relative change in health-related quality of life resulting from a treatment. As such, health utility can be a key driver of the cost-effectiveness ratio. Obtaining health utility values that are suitable for your economic evaluation, however, may not always be straight forward.
More info >>

White Papers

Detecting Integrity Breaches in a range of Pharmaceutical Blister Package Types using Sepha VisionScan

Sepha Limited

Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. Compared to bulk packaging, blister packs offer improved product integrity, tamper evidence and reduce the likelihood of misuse. Packs can be composed of either a thermoformed polymer or cold formed aluminium tray, with a number of individual pockets to hold the product. After the tablets or capsules are placed in the pockets, the packs are heat sealed with a paper or foil laminate sheet. These various stages can be completed separately or integrated into a single form, fill and seal process. There is a risk of microbial containment or degradation of the contents if any defects are present in the packaging. Such defects can take the form of rips or pinholes in the tray, or lid materials, faulty seals and channel leaks between pockets.
More info >>

Industry Events

BIO-Europe Spring 2018

12-14 March 2018, RAI Amsterdam, Europaplein, NL 1078 GZ, Amsterdam

BIO-Europe Spring® is the springtime counterpart to EBD Group’s flagship conference, BIO-Europe®, and continues the tradition of providing life science companies with high caliber partnering opportunities. Featuring EBD Group’s sophisticated, web-based partnering system, partneringONE®, the event enables delegates to efficiently identify, meet and get partnerships started with companies across the life science value chain, from large biotech and pharma companies to financiers and innovative startups.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement