spacer
home > ict > winter 2008 > the trials of temperature control
PUBLICATIONS
International Clinical Trials

The Trials of Temperature Control

Retaining control over the temperature of the drugs used in clinical trials is becoming increasingly challenging but, with careful planning and investment in the latest technology, the obstacles can be overcome, explains Geraint Thomas of Laminar Medica

With the cost of the research and development of a new drug now estimated to be $800 million (approximately €600 million), the margin for error when conducting clinical trials is arguably smaller than ever. However, with trials being carried out further and further away from the bases of sponsors and clinical research organisations, retaining control over how drugs are stored and handled is becoming increasingly difficult. Both physical obstacles, such as extreme weather and topography, and social obstacles, from language barriers to training issues, are making it essential that adequate protection is provided for the drugs, ensuring that they arrive at their destination with their integrity intact. This is particularly important when shipping temperature-sensitive drugs, with sophisticated packaging solutions being required to ensure the success of each trial.

LONG DISTANCE SHIPPING

With the now ubiquitous presence of prescription and off-theshelf drugs in many populations where trials have traditionally been carried out, sponsors and research organisations often have to look to foreign countries and new regions for noncontaminated test candidates. The long distances involved bring considerably more complex logistical challenges than previously, with the organisations often unable to maintain control of the drugs to be tried, negatively affecting results and, in the worst case, rendering a trial unsuccessful.


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
Geraint Thomas graduated from Brunel University in 1996 with a BSc (1st Class Honours) in Industrial Product Design. After working as a Board Game Engineer for Hasbro toys, he joined Laminar Medica in 1998 as a Packaging Development Technologist with responsibility for packaging solutions and qualification packages for insulated shipper design. Now employed as the Technical Director, Geraint has been instrumental in realising Laminar Medica’s development programme, including the expansion of the company’s qualification laboratory and R&D facility.
spacer
Geraint Thomas
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Vaisala Introduces CAB100 Industrial Cabinet for Cleanrooms

Vaisala, a global leader in weather, environmental, and industrial measurements, launches its newest offering for centralized environmental monitoring in cleanrooms: The CAB100 integrates Vaisala’s world-class instruments for monitoring parameters into a simple, pre-configured enclosure.
More info >>

White Papers

The Process of Informed Consent (written by ACRP)

CenterWatch

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to provide short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.
More info >>

 
Industry Events

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement