spacer
home > white papers > Case Study: Cmed’s Mobile Data Management Solution - Cmed Clinical Services
WHITE PAPERS
logo_Cmed_Clini.JPG

Cmed Clinical Services

phone +44 (0) 1403 755050
email info@cmedresearch.com
web http://www.cmedresearch.com
email Holmwood, Broadlands Business Campus, Langhurstwood Road, Horsham, West Sussex, RH12 4QP, UK

Case Study: Cmed’s Mobile Data Management Solution

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers.

The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Kloeckner Pentaplast Announces Plans for New Lamination Facility


More info >>


White Papers

Tightening Your Supply Chain Against Counterfeits

World Courier

As today’s global pharmaceutical supply chain grows increasingly longer and more complex, each link provides added opportunity for counterfeiters. While pending regulatory changes promise to tighten the supply chain with respect to production and distribution entities and new packaging technologies will make the identification of counterfeit products easier, the logistics of global distribution remains a weak link. How can the pharmaceutical shipper ensure the security of the supply chain over thousands of miles and extended periods of time when the product is no longer in his possession?
More info >>


Industry Events

Pharma Packaging and Labeling East Coast 2018

21-22 February 2018, Philadelphia, USA

The 10th Annual Pharma Packaging and Labeling East Coast event aims to create an environment where commercial packaging and labeling teams work together to successfully manage both creative and regulatory demands while safeguarding products and protecting patients.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement