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home > ict > Winter 2012

PUBLICATIONS

International Clinical Trials

Winter 2012

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Regulatory & Business Practice

Companion Diagnostics

Biomarker Momentum

Berwyn Clarke of Lab21 Limited highlights the resurgence in the use of biomarkers in the clinical development process, and considers the implications of new technology and recent EU and US development guidelines.

Clinical Trial Outsourcing

Pharma-CRO Partnerships

Relationship Advice

Consultant John Faulkes considers the best course of action to ensure the sponsor-CRO relationship is successful, and suggests that building trust and regular communication when partnership-building is essential.

eCLINICAL

Drug Identication Links

Connecting Up

The ClinicalTrials.gov database has sought to increase the transparency of trial and drug data. Christopher Southan of ChrisDS Consulting and Hilary Stephenson of Sigma Consulting Solutions Limited suggest ways in which the resource can be improved.

Software-as-a-Service

Trial Management from the Cloud

Jan Nielsen at BSI Business Systems Integration AG surveys opinion on cloud-based CTMS systems, and highlights the factors pharma companies must take into account when adopting this software.

Developing Countries: Translation and EDC

Communication Crossroads

A number of challenges have prevented adoption of EDC in emerging countries but, as Karen I Politis Virk at Language Connections explains, progress is being made as a result of technological advances and translation guidelines.

MEDICAL IMAGING AND QT STUDIES

Cancer Drug Trials

Preclinical Targets

Bioluminescent imaging can aid preclinical efficacy assessments by providing patient relevant models. Rajendra Kumari at PRECOS discusses the role this imaging platform will play in cancer drug development.

Trial Management & Outsourcing

Budget Setting

Mature Approach

As the bid process for CROs becomes more competitive, John Bennett at JABPharma Ltd and Fiona Racher of Risk Decisions Limited recommend the adoption of a risk management strategy that allows sponsors to provide an accurate and reliable proposal.

Regional trials

Regulatory Compliance: Developing Countries

Principled Progress

Conducting clinical trials in developing countries offers a number of practical and economic advantages. However, as Aarti Pandey and Swaminath Ganesh at Wipro Technologies discuss, ethical considerations must not be forgotten.

Supply Chain & Manufacturing

R&D Outlook

Pressure on the Pipeline

Mark Egerton of Quotient Clinical suggests an innovative change to the supply chain process that will help the industry overcome the economic pressures that R&D is currently facing.

Recessionary Environment

Site Management

Survival of the Brightest

The effects of the economic recession are being felt in both Big Pharma and small biotech companies. Alan Wade at CPS Research highlights the benefits of increased efficiency and diversification.

Risk-Based Monitoring

Time for Change

Jules T Mitchel and Judith M Schloss Markowitz at Target Health Inc. consider the advantages of risk-based monitoring and direct data entry.

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News and Press Releases

Colorcon, Inc. Launches Nutrafinish® Label Friendly Tablet Coatings for Nutritional Supplements Market

Harleysville, Pennsylvania, USA, 23rd February 2021 - Colorcon, a world leader in the development and supply of film coating systems and excipients, today announces the expansion of its Nutrafinish® Film Coatings portfolio to include Label Friendly and TiO2-Free coating products for the nutritional and dietary supplements market.
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	White Papers
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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