spacer
home > ict > autumn 2016 > what is the risk?
PUBLICATIONS
International Clinical Trials

What Is The Risk?

Access to high-quality, real time data is the driver behind risk-based monitoring (RBM) – a methodology used to enhance subject safety and data quality, and to deliver significant efficiency benefits. An RBM approach replaces the in-person, 100% source data verification (SDV) process based on the identification of risks and issues. Its use in clinical trials is increasing as sponsors begin to realise the potential to improve the quality of data while, at the same time, reducing total trial costs by an estimated15-20% (1). This approach is also in line with the push from regulatory authorities in the US and EU for targeted monitoring, as it is more effective than spreading resources equally across all sites.

However, managing and analysing all clinical data during the study – to identify potential current issues and future risks – is a complex speciality, which becomes particularly challenging in global, multi-site trials. Large pharmaceutical companies and CROs may have entire departments devoted to this, but that kind of scope and expertise is expensive and, for many small- and midsized biopharmaceutical and device organisations developing a product on a budget, it simply may not be an option.

Aligning these smaller teams with affordable and robust technologies, which enable the adoption of a risk-based approach to study monitoring, creates cost efficiencies that can significantly benefit them without compromising data value or patient safety.

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
Greg Ambra is Vice President of Clinical Operations at DZS Clinical Services. With nearly 20 years of experience in the clinical research industry, he has held strategic leadership positions in various sponsor and CRO companies. Greg has led DZS Clinical Services since 2012, and earned his Master’s degree in Medical Sciences from Boston University, US.

As Senior Director of Biostatistics, Jean Battikha has worked in the pharma industry as a statistician for nearly 40 years. He has been involved in the design, analysis and reporting of many clinical trials across several therapeutic areas, as well as with many NDA submissions in both the US and EU.
spacer
Greg Ambra
spacer
spacer
spacer
Jean Battikha
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PCI Pharma Services Announces Organization Updates

Philadelphia, PA – May 20, 2019 – PCI Pharma Services, a leading biopharmaceutical outsourcing services provider, is pleased to announce the following management updates to help drive the company’s future vision, strategy and growth.
More info >>

White Papers

Utilising Big Data to Produce Faster and Cheaper Clinical Research

Medical Research Network (MRN) Limited

Recruitment and retention of patients remains the major challenge to ensuring trials run as fast as possible and give them the statistical power they are designed to produce. This is not just about getting better any more - but about stopping the deterioration of these metrics in modern clinical trials.
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement