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International Clinical Trials

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Spring 2010
   
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Regulatory & Business Practice
Walter Janssens, Kristof Bonnarens and Greet Musch at the Federal Agency for Medicinal and Health Products, Belgium, outline the regulatory rules for exploratory clinical trials.  
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Trial Management & Outsourcing

Mario Tanguay of Anapharm looks at new strategies for designing and conducting Phase I studies which can help to streamline the early clinical drug development process.

 
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Having already been recognised and applauded for their achievements to date,Vanessa Poustie gives us an insight into what else to expect from the NIHR Medicines for Children Research Network as they work towards improving child health.  
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Planning for a clinical study is more than just determining the aim, as John Shillingford at Averion will tell you; in these times of financial crisis, the metrics – costs and timelines – of a study are just as crucial.  
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Scientists are probably not always best known for their communication skills, concealing inadvertently the very thing they mean to communicate. Julia Forjanic Klapproth and Barry Drees of Trilogy Writing & Consulting GmbH examine the role of the medical writer as a strategic partner on the clinical team.  
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Regional trials
Karen Politis Virk at Language Connections looks at the benefits of outsourcing clinical trial research to South Korea over other emerging markets, as well as the challenges faced by investigators.  
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If you’re thinking of conducting clinical trials in the Middle East and North Africa, Maha Al-Farhan of ClinArt International provides accurate up-to-date information about the laws and regulations in the region.  
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data management & statistical analysis
As the functional service provider (FSP) model increasingly replaces the traditional CRO paradigm for data management, Nelson Lee at the Society for Clinical Data Management reveals the elements needed for a successful FSP partnership.  
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John F Tomera at WorldCare Clinical illustrates how adaptive clinical trials may be the future of R&D – citing adaptive designs, interim analysis and imaging CROs as tools for ensuring more effective portfolio management.  
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Paula McHale at Perceptive Informatics explains why, despite the availability of electronic data capture technology, paper can be the best way to go on occasions. She provides guidelines for selecting a good hybrid tool that can manage both means of data collection.  
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With the recent financial pressures on the pharmaceutical clinical development process, Ed Krasovec of STARLIMS Corporation explores the use of Laboratory Information Management Systems as a solution to the problem – improving efficiency and reducing costs.  
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Drug delivery & Therapeutics
Intranasal drug delivery has always been a viable alternative to oral or subcutaneous routes for drugs with low bioavailability and, despite the challenges involved, recent developments have been eye-catching, explains Andrew Leary at Shandon Clinic.  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
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August, and November

News and Press Releases

Signant Health Launches Partner Program to Team with Clinical Research Organizations (CROs) Committed to Improving Clinical Trials with Patient-Centric Technology

PHILADELPHIA – August 12, 2019: Signant Health (signanthealth.com), a leading provider of technology for clinical research, today launches the Signant Health Partner Program, a significant investment the company is making to enable clinical research organizations (CROs) to better serve sponsors in the areas of Patient Data, Patient Experience, Clinical Supplies, and Endpoint Quality Solutions. By becoming a Signant Partner, CROs will benefit from new commercial and operational advantages that only come with membership.
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White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
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