samedan logo
 
 
spacer
home > ict > Summer 2013
PUBLICATIONS

International Clinical Trials

ict
Summer 2013
   
Text
PDF
bullet
TRIAL MANAGEMENT

Study Management

Role Model

As the role of clinical research associates becomes more specialised, their skillset and knowledge must be expanded to take account of new technology tools and closer working with site teams, argue Marcin and Martyna Stefanowicz at Trial-Med.

 
view
download pdf
Bioinformatics

Living the Sample Life

The accelerated use of biomarker-based studies across R&D necessitates a new rigour and sophistication in sample and data management. Mark Collins at BioFortis makes the case for a more holistic approach to information and processes.
 
view
download pdf
GCP Audits

Self Improvement

Self-auditing of good clinical practice presents a conflict of interest and rarely helps improve trial delivery. Smaller, more proactive audits, on the other hand, can offer a more intelligent analysis, argues Matthew Weinberg at The Weinberg Group.
 
view
download pdf
Risk-Based Monitoring

Check Points

The pharma industry is keeping a close eye on the early adopters of risk-based monitoring approaches, prompting Becky Carpenter at ResearchPoint Global to consider the pros and cons, and offer some case studies to show the effi ciencies and savings that can be made.
 
view
download pdf
bullet
eCLINICAL

EDC Studies

Electro Motion

Evaluating the current state of electronic data capture, Stuart Cook at Quanticate asks how far off we are from a utopian e-clinical future, where data is recorded once and is available directly in the database.

 
view
download pdf
bullet
CLINICAL THERAPEUTICS
HIV Therapeutics

Combined Forces

Assessing the European HIV drug market, Deepika Pramod Chopda at Frost & Sullivan says that combination therapies are likely to rise due to higher success in treatment rates and stronger adherence by patients.
 
view
download pdf
bullet
PREVIEW
ICSE Preview

Show Time

With outsourcing now dominating the clinical research landscape, the upcoming ICSE event in Frankfurt is a must-attend.
 
view
download pdf
bullet
Regional trials
Global Operations

Beyond the Borders

With trials now being carried out worldwide – and often in nontraditional markets – study planners must consider country-specific differences in trial cost and quality of data. Jeffrey Handen and Irina Rafalovitch at Medidata Solutions report.
 
view
download pdf
South American Market

Latin Leads

Argentina is leading the way in Latin America, with a large number of Phase 3 trials across critical disease areas and a favourable set-up that is attracting pharma multinationals. Ashish Mehta at GlobalData offers a statistical picture.
 
view
download pdf
bullet
data management & statistical analysis
Data Analysis

No Limits

Life sciences companies are sitting on mountains of data, yet only extract a fraction of its value. Why be held back, says Rick Morrison at Comprehend Systems, given the advantages of the next generation of software tools?
 
view
download pdf
bullet
Drug delivery & Therapeutics

Antibiotic Development

Fighting Resistance

As Big Pharma backs away from antibiotic development, the field has opened up to smaller, innovative companies that work closely with universities. Michael McArthur at Procarta Biosystems illustrates some of the early-stage research being done.

 
view
download pdf
bullet
Central Labs
Biomarker Validation

Question Mark

A detailed understanding of how biomarkers can be assayed in drug development is pivotal for allowing critical decision-making. Edwin Janssen at Eurofins Global Central Laboratory outlines how rigorous validation is key to success.
 
view
download pdf
Clinical Laboratories

Direct Action

The growing use of biomarkers in Phase 1 trials raises the need for a flexible quality framework to help ensure data integrity, reconstructability and reliable results. Barbara Baert and Ellen Berteloot at Janssen explain.

 
view
download pdf

Training & Development
Business Planning

Train to Gain

Appropriate, well-delivered clinical research training is particularly important during hard economic times, helping to drive staff development and business performance, says Gerald Van Roey at the European Centre for Clinical Research Training.
 
view
download pdf

Trial Design
Adaptive Design

Rapid Response

They have the potential to transform clinical research, but adaptive designs also pose various operational and logictical demands. Fast response services to support mid-trial modifications may hold the answer, says Sue Miles at Packaging Coordinators, Inc.
 
view
download pdf
Intelligent Trials

Flexible Working

Adaptive designs can help pull off the balancing act of streamlining trials without risking poor design or delays. And the ethics and science can be improved too, as Ghanashyam Rao and Indu Singh at ELC Group explain.
 
view
download pdf
Protocol Writing

Words of Wisdom

With more complex trial protocols likely to be less successful, Julia Forjanic Klapproth at Trilogy Writing & Consulting emphasises the need for well-designed and communicated protocol documents.

 
view
download pdf

Interview

Business Insight

Good Advice

ClinTec’s Rabinder Buttar reveals some business tips and her thoughts on how companies can thrive in the decade ahead.

 
view
download pdf

Industry Interview

Thinking Allowed

Neta Kela-Madar of Biotec Services talks about supply strategies and working with regulation amid the globalisation of clinical trials.

 
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

Horizon Discovery and Fulcrum Therapeutics Form Collaboration for Novel CRISPR-Based Target Discovery in Genetic Diseases

The collaboration will utilize Horizon’s world-leading CRISPR-based screening platform to identify novel targets for regulating gene expression.
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

Industry Events

BioPharm America™ 2017—10th Annual International Partnering Conference

26-27 September 2017, 39 Dalton Street, Boston, MA 02116

BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement