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International Clinical Trials

ict
Spring 2011

   
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REGULATORY

Along with recent legislation, Alexander Cvetkovich-Muntañola and Kathryn Bohannon of INC Research look at the factors to consider when designing a paediatric protocol, highlighting that the many complications associated with clinical trials in children mean that sponsors should commit sufficient time to formulating a strategy before initiating such studies.


 
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Consultant Stephen A Goldman examines current perspectives and approaches to pharmacovigilance planning and risk management throughout the medical product life cycle, from clinical trials through product approval to marketing.
 
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Since the enforcement of the Paediatric Regulation in 2007, sponsors must now complete a paediatric investigation plan (PIP) when seeking marketing approval for unauthorised drugs or new indications. Douglas Fiebig at Trilogy Writing & Consulting puts forward the six main steps when preparing a PIP application.
 
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Regional trials
Clinical research in Central and South American countries and the Caribbean is by no means a new phenomenon, but recent regulatory changes and political developments have caught the headlines.Maria Alejandra Espinosa and Ivana Etcheverry at Omnicare Clinical Research reacquaint us with the region, giving a breakdown of the changes by country.
 
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
As the clinical research associate’s role evolves to take a more hands-on approach to site management, Liz Love of Perceptive Informatics examines how eClinical solutions and clinical trial management systems will help them make their decisions easier.
 
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Linda Bowers of IntraLinks discusses how software-as-a-service based solutions can be used to strengthen the relationship between investigators, as well as build various strategic partnership models between sponsors and CROs.
 
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THERAPEUTICS
Douglas W Loe of Versant Partners discusses the potential of using oncolytic viruses as a form of cancer treatment, giving an update of viruses in various stages of development for a range of cancers, as well as some indicators of potential future sales earnings that can be derived from these treatments.
 
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Labs & Logistics

Data management for the pharmaceutical cold chain is a considerable challenge. Martin Peter at ELPRO-BUCHS AG Switzerland investigates the different techniques on offer for collecting this essential data, as well as how to overcome the challenges it may create.


 
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Russ Hager of BioStorage Technologies highlights the growing role of cold chain management in supply chain processes, and emphasises the various factors that ensure on-time, compliant transportation of temperature-sensitive clinical trial materials and supplies.

 

 
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bulletMetrics Champion Consortium

In spite of how ‘old’ the pharma industry is, there is still a lack of industry-adopted clinical trial performance metrics.However,well-defined standards are needed to provide the fundamental tools for running efficient, effective clinical trials, explains Linda Buchin Sullivan of the Metrics Champion Consortium (MCC).


 
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Nick Jackson at i3 presents both a customer’s and a CRO’s perspective on using the MCC metrics, and discusses the role of the Process Improvement Work Group.
 
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Business Practice
Like any other business, pharmaceuticals need performance indicators to measure business success, but unlike any other business, the industry has a unique model. So, how do you pilot a business that is like no other? Dimitri Stamatiadis at Merck Serono suggests that a balanced scorecard might be the answer.
 
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Company stakeholders frequently view quality assurance as a ‘nice to have’, and are not always aware of its full impact on the organisation if it is not taken seriously. Nicky Dodsworth and Sherri Hubby at Premier Research Group Ltd stress that in the struggle for survival in today’s regulatory environment, quality assurance must take a more active role.

 
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As with every other aspect of life, clinical research companies must ensure they have appropriate insurance for their activities.However, they cannot afford for this protection to hinder speed-to-market efforts. As a result, there is a need for web-based technologies to make the process more efficient and transparent, explains Kathleen Burns of Aon eSolutions.
 
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Training & Development
For an industry boasting excellence and the use of cutting-edge technology in all aspects of its operation, the pharma world is only just beginning to regard the role clinical events with the same importance as other parts of a study. Andy Thurstan at MD Events considers best practices for planning and delivering outstanding meetings.
 
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It is vital that clinical research organisations have well-trained employees who are equipped to operate at the highest standard.Gerald Van Roey at the European Centre for Clinical Research Training gives some tips for designing a strong staff development programme.
 
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Many organisations are trying to find ways to cut their budgets, and often one of the first casualties is training. However, developing a strong coaching culture in an organisation can prove to be a cost-effective measure in the long term, explains Martin Robinson of Dovetail Clinical.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

BioBLU® family grows

Juelich/Hannover, October 14th, 2013 – At this year’s BIOTECHNICA in Hannover, Germany Eppendorf has presented the newest members of its single-use bioreactor family BioBLU for the first time. With the new single-use bioreactor BioBLU 1c for cell culture and BioBLU 1f for microbial applications Eppendorf further extends its portfolio of rigid wall single-use bioreactors. These 1 L vessels are bridging the gap between the BioBLU 0.3 c/f mini single-use bioreactors and the larger vessels of the BioBLU family. Users in cell culture, who want to combine the advantages of single-use technology with the proven qualities of stirred-tank bioreactor design can now benefit from an unmatched portfolio of rigid wall stirred tank single-use bioreactors with working volumes from 100 mL – 40 L.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

Pre-Filled Syringes Conference and Exhibition

28-29 January 2015, Marriott Regents Park Hotel, London, UK

Join Pre-Filled Syringes- 2015 and be part of a major networking opportunity providing intimate interaction with your peers, where you will hear case studies, presentations and round table discussions on the key issues surrounding the latest developments in the pre-filled syringes market and regulatory considerations.
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