International Clinical Trials |
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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.
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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.
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Observational Studies
Legislative Labyrinth
Conflicting local rules can render observational studies in the EU difficult to conduct. Giovanni G Fiori at Medidata srl discusses how to overcome the challenges suggesting that EU-wide regulations would improve the situation.
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First in Human Studies
Control is Critical
Seenu Srinivasan of Covance considers how chemistry, manufacturing and controls (CMC) development strategies can improve trial efficiency and reduce time to the important first in human milestone, and offers advice on how best to conduct the CMC development process.
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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.
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Medical Photography
Snap Decisions
As photography plays an increasingly important role in clinical research, Jo Truelove of Illingworth Research highlights how to get the most out of a valuable resource.
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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.
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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.
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Regional Trials: MENA
Riches on the Horizon
Big Pharma has traditionally viewed the Middle East and North Africa as a location for clinical research with caution. Yet, as Chiheb Guerfel of Poseidon Pharma Services explains, a number of advantages are attracting sponsors to the region.
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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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Drug Identi cation 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.
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Study Protocol Design
Chart Toppers
Krista Payne, Dara Stein, Lynne Marshall, Jess Sohal and Jersino Jean-Mary at United BioSource Corporation explain the benefits of conducting multinational chart reviews as a method for gaining real-world data, and suggest how best to integrate these reviews into clinical research.
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Passive Cooling
System Secrets
Understanding the requirements of the cold chain is essential to conducting a successful trial, yet is often overlooked. Geraint Thomas at Laminar Medica explores the importance of adopting the right passive cooling system.
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Cool Chain Translation
Ship Ahoy
Larry G Stambaugh at Cryoport, Inc and Tracy Hendershott at ACM Global Central Lab explore the developments in cold chain technology that are aiding the growing number of trials around the globe.
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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.
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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.
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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.
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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.
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