spacer
home > ict > winter 2021 > seek a system that makes the complex, simple
PUBLICATIONS
International Clinical Trials

Seek a System that Makes the Complex, Simple


As a way to increase clinical trial productivity, sponsors are increasingly turning to adaptive trial designs to gather more information, involve fewer patients, and improve the ethical treatment of patients – especially in oncology and rare diseases (1). So too, sponsors in these therapy areas are finding that platform trials that use master protocols can increase efficiency and accelerate development timelines.

Still, these modern trial designs are not yet common because they’re complex to manage and present more risk than the traditional series of trials that investigate one drug using a typical blocked randomisation design. The complexities extend to programming and configuring the interactive response technology (IRT) system that supports patient randomisation, drug assignment, and supply management.

Although the industry generally places a premium on accelerating IRT start-up timelines, in the case of these complex trials, sponsors are better served to focus on the experience of the vendor and the quality/thoroughness of the work. The adage, ‘more haste, less speed’ applies here.

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
Sylvain Berthelot is an IRT Technical Solutions Director at Calyx. Sylvain applies innovative solutions to reduce the technology burden imposed on sites, allowing them to focus on what is the most important: patients. Over his 10 years in the industry, Sylvain has managed product strategy for various eClinical solutions such as IRT, EDC, eCOA, and patient sensors. He is now one of the driving forces behind Calyx’s IRT product innovation.

sylvain.berthelot@calyx.ai


Malcolm Morrissey is an Associate Director, Statistics and Product Support Services at Calyx. Since obtaining a PhD in Statistical Inference in 2001, Malcolm has had broad experience as a research associate, statistician, and manager in the pharmaceutical industry. He joined Calyx in 2005 and currently manages a team whose duties include supporting and developing randomisation and medication management algorithms for clinical trials managed by IRT.

malcolm.morrissey@calyx.ai
Print this page
Send to a friend
Privacy statement
News and Press Releases

3P Biopharmaceuticals appoints José Luis Bartolomé as Operational Excellence Director

[Noáin, Spain, September 30, 2020]3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organization (CDMO) specialized in process development and cGMP manufacturing of biologics, appoints a new member to the management team with the incorporation of José Luis Bartolomé as Operational Excellence and Continuous Improvement Director.
More info >>

White Papers

What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement