spacer
home > ict > current issue
PUBLICATIONS

International Clinical Trials

ict
Summer 2014

   
Text
PDF
Comment from the Editor

As many articles in this edition highlight, the industry is reshaping in the face of multiple pressures and demands – prompting Graham Hughes to offer his take on the coming reformation.
 
view
download pdf
bullet
REGULATORY
Regulatory Update

Europe in Harmony?


The incoming Clinical Trials Regulation will simplify and speed up trial applications and approvals across Europe. But, as Peter Kennerley and Clara Ezed from Emas Pharma make clear, potential hurdles lie in wait, such as get-out clauses and differences in medical practice and language.
 
view
download pdf
bullet
TRIAL MANAGEMENT
Drug Safety

Active Ingredients


Doing business in new markets brings greater exposure to safety and regulatory risks. Chitra Lele at Sciformix examines how this is prompting a shift to a more proactive pharmacovigilance model with data analysis, stakeholder input and benefit-risk balance at its core.
 
view
download pdf
Site Performance

Going Metric

A shared, consistent set of standards and metrics to assess the performance of clinical research sites is moving closer due to an ongoing multi-stakeholder initiative. Greg Koski and Mary Tobin at ACRES, and Eve Shalley at Essex Management report.
 
view
download pdf
bullet
Clinical Trial Outsourcing
Clinical Support

Local Economy


Outsourcing pharma and biotech firms will become more reliant on clinical support services with the expected explosion of monoclonal antibody products. Alcura UK's Gad Neama outlines how help across all study phases can streamline the trial and approval pathway.

 
view
download pdf
bullet
eCLINICAL
Electronic Data Capture

Power Source

Clean, reproducible site data remains a bedrock of clinical research, but with traditional methods feeling the strain, eSource is stepping forward. Ann Neuer at Medical deScriptions explores how it not only eliminates transcription errors, but also enhances risk-based monitoring.
 
view
download pdf
eClinical Platforms

CTMS – The Decade Ahead


The clinical trial management system is much more than another product in the eClinical suite, and it must now be future-proofed to meet new trends. Predicting a move to a modular structure, PAREXEL's Liz Love considers the needs of end-users in the years ahead.
 
view
download pdf
bullet
MARKETPLACE
Bio Investment

Cash Points


Marketed as ‘Where great minds, smart money and key dealmakers meet’, this year’s BioTrinity conference explored biomedical investment trends and the growing alignment between pharma and venture capital. Graham Hughes was there.

 
view
download pdf
bullet
Regional trials
Focus on Russia

Central Resources

Formed in the late 1990s, Russia's clinical trials market remains a highly centralised system, with oncology studies taking the lead. Yuri Afonchikov at Synergy Research Group, and Artem Poltoratskiy and Petr Krivorotko from Petrov Research Institute of Oncology offer a snapshot.
 
view
download pdf
BRIC Markets

Ups and Downs

The BRIC markets are in flux – and Big Pharma is trying to keep up. Aside from the continued growth of China, initiated trials in Brazil, Russia and India are in decline, yet some companies still see rich pickings. Beth Nuskey at Thomson Reuters has an assessment.
 
view
download pdf
bullet
data management & statistical analysis
Data Collection

Tech Track


Systems to eliminate the variability in data collection have yet to fully reach the clinical trial space, but the need for predictable, reproducible measurements means advances are edging closer. Abraham Gutman from AG Mednet looks at the technology toolbox.
 
view
download pdf
bullet
Labs & Logistics
Lab Innovation

On the Button


'Making innovation count' should be the new mantra for global labs. As Paul Travis of Medpace explains, they can offer the industry vital support to integrate data, enhance study performance and maximise R&D spend.
 
view
download pdf

Business Practice
Trial Engagement

Empowering Patients


Lack of patient engagement is costing the pharma industry dear, so putting their views and values at the heart of clinical R&D is now seen as key to the healthcare revolution. Ulrich Neumann at eyeforpharma sets a roadmap for change.
 
view
download pdf

Training & Development
CRO Training

Talent Show


Problems recruiting clinical research associates is hastening a resourcing crisis for CROs – leading Martin Robinson from the International Academy of Clinical Research to call for new competency based training schemes.
 
view
download pdf

Trial Design
Adaptive Methods

For a Change


Cautiously optimistic might best describe the position of industry and regulatory agencies towards adaptive trial designs. Weighing the benefits and concerns, Ron Marks and Mark Shapiro of Clinipace Worldwide provide an update.
 
view
download pdf
Trial Design

Slowing Down to Speed Up


There is increasing recognition that using adaptive designs in Phase 2 trials can minimise the risk of product failure at a later stage and add significant value to eventual licensing transaction or exit, advises Phil Birch at Aptiv Solutions.
 
view
download pdf

Interview
Industry Interview

Thinking Allowed


Chris Hamilton of CROS NT tells ICT about the European law on data transparency coming pharma's way in 2016 – and how to prepare.
 
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

Catalent Expands Its Technology Offerings in Biologics, Acquires Redwood Bioscience Inc. and the SMARTag(TM) Technology Platform

SOMERSET, N.J., Oct 02, 2014  -- Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has acquired the remaining stake in Redwood Bioscience Inc., and the SMARTag Antibody-Drug Conjugate (ADC) technology platform. In Catalent’s first acquisition since its IPO in July, the company continues to execute its strategy to build a differentiated technology offering and strengthen its position in the fast growing biologics market.
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

Clinical Trial Supply Europe

25-26 February 2015,

The 15th Annual Clinical Trial Supply European 2014 conference took place last February in Rome and we were delighted with the feedback from the event. This event boasts flagship status as it poses as our largest event across Europe, attracting at least 400 industry representatives and 50+ service providers.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement