International Clinical Trials |
 |
|
|
|
|
 |
| |
|
|
|
Dr Graham Hughes reflects on the importance of clinical trial sample storage. |
|
|
|
|
|
Quality Oversight Programmes
High Standards
Third-party quality oversight programmes provide sponsors with an impartial assessment of their study, which can help to reduce costs and ensure regulatory standards are being met, as John R Wilson Jr at Beaufort, LLC discusses. |
|
|
|
Medical Devices
Off to Market
Karen Lunde and Stephan Joeken of CERES, Clinical Evaluation & Research share their thoughts on how best to compile a clinical investigation report to gain CE approval for a medical device. |
|
|
|
Cancer Drug Development
Data is King
Todd Clark at Value of Insight Consulting explains how the requirements of the FDA approval process can aid the development of cancer drugs by gathering information on endpoints, timelines, populations and safety results. |
|
|
|
|
Clinical Trial Management
Efficient Beginnings
The development of comprehensive risk and contingency plans, as well as sound communication plans, is essential when setting up a global clinical trial, as Kellie Malloy at PharmaNet/i3 explains. |
|
|
|
|
Outsourcing
The Art of Listening
Maintaining an equal and open relationship between sponsor and service provider can help ease the clinical trial process and encourage innovation, as Andy Thurstan of MD Events explores. |
|
|
|
|
Electronic Document Management Systems
Know Your Numbers
Rhonda J Paz and Diandra Nuno-Salcido of GuideStar Clinical Trials Management suggest how the formation of a regulatory document can benefit from adopting the right electronic document management system. |
|
|
|
Clinical Trial Applications
Submission Statement
Helle Ørbæk and Lillan Rejkjær of IWA Consulting explain how electroniccompatible clinical documentation provides an efficient and cost-effective method for submitting regulatory documents. |
|
|
|
|
Clinical Trial Labelling
Designer Label
Global clinical trials pose considerable challenges to the labelling process. Pernille Smith of CCL Label Healthcare discusses the methods being employed to overcome these difficulties. |
|
|
|
|
Phase 1 and 2a Clinical Trials
Graham Hughes reviews the key presentations on proof of concept and venture capitalism at the London conference. |
|
|
|
Sample Management Strategy
Learn how successful sample management can help support the development of new therapies at the Global Sample Management Benchmarking Symposium. |
|
|
|
|
|
Regional Trials: South-East Asia
SEA Power
Kenneth Lee and Helen Neal at PRA consider the growth of clinical research in South-East Asia, and suggest that understanding the unique challenges of the region is essential. |
|
|
|
Hardware Fulfilment
Tools of the Trade
Karen Harley of Bracket and Christopher Nightingale describe how knowledge of local restrictions and regulations is critical when shipping hardware for a clinical trial, helping to prevent costly delays to the study. |
|
|
|
|
Central Laboratories
Rising to the Challenge
As the clinical research sector expands and trials become increasingly complex, central laboratories must learn to adapt to new pressures, as Graham Hughes and Richard Barrett, Consultants in Pharmaceutical Development discuss. |
|
|
|
|
|
Metrics Champion Consortium
From Evolution to Revolution
Guy A Mascaro of the Metrics Champion Consortium explains the role that the organisation is playing in helping sponsors to improve the clinical research process. |
|
|
|
|
|
Adaptive Designs: Early Phase Trials
Keys to Successful Design
Denis Gossen and Dominique Demolle of Aepodia explain how, with adequate planning, adaptive trial designs in early phase research can help to improve accuracy and efficiency. |
|
|
|
|
|
Post-Marketing Research
Planting the Seed
Post-marketing research (PMR) is growing in importance, with regulatory authorities increasingly requiring studies that confirm the ongoing safety of a newly-approved drug. Thomas Wagner of Trilogy Writing & Consulting advises on how to design a successful PMR plan. |
|
|
|
Patient-Friendly Trials
Home is Where the Trial is
Home trials can be difficult to set up, but Graham Wylie of the Medical Research Network suggests that these studies are worth the risk as they offer considerable benefits to patient recruitment and retention. |
|
|
|
|
|
Industry Interview
Thinking Allowed
ICT talks to Steve Cutler of ICON Clinical Research Services about his views on the clinical trials industry and how it might develop in the future. |
|
|
|
|
|
Metrics Champion Consortium
