spacer
home > ict > spring 2017 > on the lake
PUBLICATIONS
International Clinical Trials

On the Lake

Clinical trials require the management of more data than ever before, but many of the tools available on the market have prodigious shortcomings in both this and safety. Sponsors and CROs struggle to collect, synthesise and analyse information from myriad siloed sources, which affects their understanding of drug safety and slows data reconciliation for submission. An alternative approach to data integration could power the next generation of clinical innovation by bridging the functional and structural gaps between information management and pharmacovigilance (PV).

Regulatory agencies are concerned about trial data quality and patient safety. The recent emphasis on risk management in the latest ICH E6 (R2) guidelines makes it clear that there is significant work to do in removing the barriers to data review, quality oversight and safety monitoring. Both sponsors and CROs rely on an increasing number of systems and datasets to manage complex and often decentralised clinical studies. Their data are often siloed, which makes obtaining a holistic picture of the trial challenging.

Most data management solutions on the market today are inflexible and fall short in their ability to power the solutions needed to best manage clinical research, particularly as they pertain to timely interfaces with PV. All PV systems will ultimately provide information in the E2B format as required, but data structures from clinical data management systems (CDMS) vary, and conversion to study data tabulation models or other formats can delay key deliverables for holistic study risk and safety management.

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 co-founder and Chief Executive Officer of ThoughtSphere. Prior to starting the company, he was the global leader of products for Quintiles, creating and leading the strategy team behind a $60 million integrated healthcare data hub. Sudeep 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

Eitan Group Rebrands as Eitan Medical

NETANYA, Israel, November 16, 2020 Eitan Medical announced today that, as of November 16, 2020, it has rebranded, consolidating its product lines under the new Eitan Medical brand. Eitan Medical is a global leader in advanced infusion therapy solutions across the care continuum.
More info >>

White Papers

Spotlight on Quality in Study Startup

Oracle Health Sciences

This white paper addresses the growing interest in quality in clinical trial execution and how workflows play an essential role by building in the steps needed to comply with TMF guidelines, reducing downstream problems. This proactive strategy limits issues caused by siloes, yielding process improvements measurable by performance metrics.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement