Webinar on “Centralized Monitoring: A Smart & Cost –Efficient Clinical Monitoring Approach” : 5th September 2014 ; 10.00 – 11.00 hrs US EST

Pharmaceutical Regulatory Affairs

Part I – Centralized Monitoring: Understanding Concept & Process

As the complexity of clinical trials has increased significantly in the last few years, it is becoming more challenging for drug development companies to manage the cost of clinical development. The clinical monitoring cost accounts for one third of the total clinical trial management budget. However, traditional ways of conducting frequent monitoring visits for example every 4‐6 weeks to investigational sites, and 100% source data verification, do not necessarily guarantee higher data quality, better patient safety, or identify the critical issues early on. Therefore, it is imperative to look into alternative and smarter ways to proactively identify risks to data quality, and patient safety, in a cost‐efficient manner. Of the innovative monitoring approaches available, centralized monitoring appears to be the most suitable approach to enhance data quality and ensure patient safety in a cost effective manner. The FDA guidance document specifically encourages use of centralized monitoring techniques for certain monitoring activities, in place of, or to complement, traditional monitoring practices. Considering the need of centralized monitoring for efficient clinical trial management, MakroCare has organized this webinar in two parts to provide more insights on the process and implementation of centralized monitoring.

Centralized Monitoring: Understanding Concept & Process

  • Centralized monitoring concept
  • Centralized monitoring -regulatory perspective
  • Centralized monitoring as part of RBM
  • Centralized monitoring to support late phase studies
  • Centralized monitoring models
  • Real case scenario on the benefit of a centralized monitoring approach

Speakers

Sue Fitzpatrick
Director of Redtree People and Independent Training Consultant
Former Head of Education and Training
The Institute of Clinical Research, UK

Sue_Fitzpatrick_1

Jane Tucker
Independent Risk Management Consultant and Trainer, UK

 Jane_Tucker

Speaker & Facilitator

Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA

Ashok_Ghone_3[1]

 Date & Time :
Date:
Friday, 5th September 2014
Time:
10.00 – 11.00 hrs US EST / 15.00 -16.00 hrs UK (BST)

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

Part II: Adopting Centralized Monitoring Approach (on 6th October 2014; details will be shared later)

 

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