spacer
home > ict > winter 2009 > ecg's digital future
PUBLICATIONS
International Clinical Trials

ECG's Digital Future

During drug development, early phase clinical trials are carried out in specialised units under optimal conditions for executing reliable studies, with the greatest respect for volunteer safety. These clinical facilities are highly specialised and personnel are carefully trained in performing clinical studies. Increasingly, they are equipped with powerful medical devices useful in analyses and measurements which are used in the evaluation of a test compound.

In relation to cardiac safety monitoring, the following three methods have historically been used:

  • Telemetry for continuous cardiac safety monitoring
  • Holter ECG for ambulatory, long-term recording of cardiac activity
  • Rest ECG to obtain a snapshot of cardiac activity at a specific time point

Over the past 10 years, the industry has been witness to a major evolution in relation to the hardware used in ECG recording, and more specifically with the introduction of digital technology. In parallel with this technological evolution, regulatory authorities have increased their requirements for submissions. For example, a pharmaceutical company submitting a thorough QT/QTc study to the FDA must provide annotated ECGs in an electronic format (1). This, in turn, has pushed clinical units to update their equipment concerning ECG management. Admittedly, this update is a significant financial investment, mainly due to user training and system validation. However, this investment is rewarded as it provides the opportunity to go even further when it comes to cardiac safety. This is made possible in part by implementing a full system for collecting and managing information: the creation of an ECG warehouse.


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

Philippe L’Hostis has been with Biotrial for over 10 years and was recently promoted to Head of the Central Lab. He was previously Head of Data Management and holds a MSc in Statistical and Numerical Engineering. Philippe brings important leadership to the central lab, building on his expertise in data management, as well as his overall knowledge in clinical research. Among other areas, his attention is currently focused on the development of new methods of analysis and signal processing in collaboration with university partners.

 

spacer
Philippe L'Hostis
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Nemera acquires Insight Product Development to strengthen its capabilities

“Every day at Nemera, we work to improve the lives of millions of patients worldwide by designing, developing and manufacturing innovative drug delivery devices. Our vision as a team is to become the most patient-centric drug delivery device company in the industry. We partner closely with our customers to deliver innovative and high quality devices, to ensure that patients will receive the best product and service possible” Marc Hämel, CEO
More info >>

White Papers

Why You Should Be Using Ultrasonic Cleaning

Natoli Engineering Company, Inc.

Clean punches and dies are essential to maintaining the integrity and efficiency of your tooling investment, as well as the quality of your product. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools – from medical instruments to tablet tooling. The Tableting Specification Manual (TSM) states, “An ultrasonic bath is ideal for cleaning tooling.” This high-tech cleaning process also saves time, reduces cost and is better for the environment.
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