samedan logo

 
 
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

A new market reference added to Safe’n’Sound®, our passive safety device platform

Safe’n’Sound® is on the market in Europe with a newly registered injectable medication. The commercial launch of HULIO™ (Adalimumab Biosimilar) was initiated in selected European markets on October 19,2018. Hulio™, developed by Fujifilm Kyowa Kirin Biologics Co., Ltd. and marketed in the European Union by Mylan N.V. is approved as a biosimilar for the same indications as the reference product, Humira®.
More info >>

White Papers

Sterile Vials Made of Tubular Glass

Gerresheimer AG

Gx® RTF vials powered by Ompi EZ-fill® enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers.
More info >>

 
Industry Events

SCOPE Summit for Clinical Ops Executives

18-21 February 2020, Hyatt Regency, Orlando, Florida, US

Celebrating its 11th successful year, SCOPE Summit 2020 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, 3 plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement