spacer
home > pmps > winter 2003 > clinical trials - meeting the logistics challenge
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Clinical Trials - Meeting the Logistics Challenge

The challenges facing the clinical trials sector have never been greater: an informed public are demanding better health and quality of life; governments and international organisations continue to enhance the scope and powers of their regulatory bodies; and investors expect healthy dividends. These commercial, medical and regulatory pressures are felt by organisations involved in clinical trials across the spectrum, including the logistics providers who are increasingly valued as key partners in the trial process rather than incidental suppliers. The logistics challenge (and how to meet it) can be viewed in two ways: how current issues are impacting on the running of clinical trials from the logistics viewpoint; and how you can get the best from your logistics providers. Understanding the issues and practicalities facing logistics providers, and knowing what you should expect from them, can only promote a more efficient and successful trial. Clinical trials logistics must adapt to constantly changing times. Issues of regulation are often at the forefront. Consider for instance the influence of international transport authorities such as the International Air Transport Association, global health bodies such as the World Health Organization (WHO), and national drug approval bodies such as the Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Local customs authorities as well as the intervention of the Department of Environment, Food and Rural Affairs (DEFRA) in the UK and the US Department of Agriculture (USDA) must also be considered.

The difficulties of running clinical trials, such as subject recruitment and providing training to investigators, are also key priorities to address in order to be successful. It is clear that gaining approval for new drugs is getting much tougher; more information needs to be provided and higher standards met, whilst keeping to tight budget and time restraints.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Jamie French, Operations Manager at Biocair

Jamie French is Operations Manager at Biocair, having joined the company in 1995 after graduating with a BA (Hons) in English and History. He is responsible for the creation and implementation of a number of procedures on the transport of research material, as well as managing the transport stage of numerous clinical studies. Since 1996 Jamie has been responsible for the company aviation security policy, reporting directly to the Department for Transport. Jamie is currently researching novel cool chain technology.

spacer
Jamie French
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

WuXi STA and Dizal Pharmaceutical Sign CMC Development and Manufacturing Agreement

STA Pharmaceutical Co., Ltd., (WuXi STA) a subsidiary of WuXi AppTec and Dizal Pharmaceutical, a biotechnology company, announce a strategic partnership. Under the terms of the collaboration, WuXi STA will become the preferred CDMO partner of Dizal Pharmaceutical for GMP production, providing integrated CMC (Chemical, manufacturing and Control) process research and manufacturing services from API to drug product.
More info >>

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.
More info >>

 
Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement