spacer
home > ict > winter 2018 > preventable problems
PUBLICATIONS
International Clinical Trials

Preventable Problems

The development and delivery of cutting-edge medical treatments, drugs, and devices depends on the successful completion of clinical trials. Such studies require high-quality data, affordability, patient safety, and time sensitivity. In today’s clinical trial climate, data are everywhere. The ways in which participant information is now collected – from wearable devices to eJournals – means that researchers are inundated with usable, insightful data. This is undoubtedly an advantage to the integrity of clinical trials, but requires innovative, sophisticated technology and IT systems to cope. However, the complexity of modern-day clinical trials extends beyond data. Increasingly, large trials become harder to manage and traditional methods of study management are no longer always sufficient. Therefore, modern approaches are needed to ensure that trial quality and patient safety are retained.

Risk-based monitoring (RBM), as a component of an overall risk management approach, provides a platform for life sciences companies to enhance the quality and integrity of their clinical trials data by prioritising resources based on the safety of subjects. RBM is an adaptive approach that directs monitoring focus and activities to the areas needing the greatest attention, which have the highest ability to impact patient safety and data quality.

RBM is becoming one of the most valued approaches in clinical trial management; by improving data quality and allowing enhanced study oversight, RBM enables clinical trial managers to utilise technology to facilitate data integration. The ultimate goal is to move traditional RBM towards a management approach, one which is now standard across the industry.

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
Sudeep Pattnaik is President and CEO at ThoughtSphere. Prior to founding ThoughtSphere, he was the global leader of products for Quintiles, the largest CRO Fortune 500 life sciences company in the world, creating and leading the strategy team behind a $60 million integrated healthcare data hub. Sudeep also played a key role in defining the risk-based monitoring approach for optimising the clinical development process and helped develop a best-of-breed RBM platform for the industry. He holds an MSc in computer science from Uktal University, India, and an MBA from Leeds School of Business at the University of Colorado, US.
spacer
Sudeep Pattnaik
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

At Pharmapack Paris, TekniPlex to Showcase Cleanroom-produced COC Films, Among Other Solutions

Wayne, PA – At Pharmapack Paris, February 1-2, TekniPlex, a globally integrated provider of innovative solutions through materials science and manufacturing technologies, will showcase samples from a range of cyclic olefin copolymer (COC) diagnostics films whose cleanroom production is a differentiator in the healthcare space. At booth B96-98, the company also will highlight another recently introduced innovation: the world’s first fully transparent recyclable mid-barrier blister package.
More info >>

White Papers

Speciality Logistics Outlook 2015

World Courier

To date, there are more than 178,000 registered clinical trials taking place across the globe, and global pharma’s volume has more than doubled over the last decade. With emerging markets showing explosive predictive growth through 2016, shippers and trial sponsors can expect continued regulatory and overall logistics complexities that foster demand for local, inmarket resources across the globe.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement