Navigation Links
Challenges and Opportunities in Risk-Based Monitoring, New Webinar Hosted by Xtalks

Toronto, Canada (PRWEB) March 01, 2013

As new legislation and guidelines arise, now more than ever, clinical researchers need to be aware of effective risk-based monitoring strategies.

This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies gained by implementing a risk-based monitoring approach.

Esteemed speakers Keith Howells, Senior Vice President of Development at OmniComm Systems, Inc., and Becky (Causey) Carpenter, Vice President of Operations, ResearchPoint Global, will discuss the concept of "risk" in terms of "lower-case risk" (the analysis and identifying of the data elements that are critical to the reliability of study findings) as well as "capital letter RISK" (where a study sponsor might perceive they are taking on by adoption of a targeted approach to monitoring).

Attendees will walk away with an understanding of risk-based monitoring , including:

  • How electronic data capture can implement a selective approach to Source Document Verification, without risk of bias
  • How to adopt a novel approach to central Source Document Verifcation
  • What tools are available for data-driven monitoring
  • Considerations for the development of a risk-based approach to monitoring

The webinar will also cover methods to adopt the draft guidance’s recommended changes in risk-based monitoring, including a review of statistical mechanisms to select forms for Source Document Verification (SDV), as well as tools that enable centralized monitoring and reductions in site visits and associated monitoring costs.

For more information about this event or to register, visit:

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit

Karen Lim (416) 977-6555 ext 227

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Probiotic Action Challenges the Use of Facial Scrubs and Antibiotics for Acne Prone Skin
2. Healthcare Sales Jobs Rising Despite Challenges Facing the Industry
3. How to Ensure Pharmacovigilance Practices are Compliant with Global Safety Requirements: Challenges in Asia-Pacific
4. Bayer Bee Care Center Helps Solve Bee Health’s Toughest Challenges
5. Global water sustainability flows through natural and human challenges
6. Conference Challenges Left-brain, Right-brain Dichotomy
7. Healthcare Cloud Computing (Clinical, EMR, SaaS, Private, Public, Hybrid) Market - Global Trends, Challenges, Opportunities & Forecasts (2012 - 2017)
8. Biodetection 2012 Conference Brings Together Leading Organizations from Around the World to Address Challenges & Technology Advances in Detection and Identification of Biological Threats in Washington, DC from June 28-29, 2012
9. Functional Circulation LLC Receives Grand Challenges Explorations Grant for Groundbreaking Research in Global Health and Development
10. QIAGEN Joins Grand Challenges in Global Health Initiative to Bring Advanced Point-of-Care Diagnostics to Worlds Poorest Countries
11. Phigenics Research Challenges Accuracy Of Conventional Legionella Testing Protocol
Post Your Comments:
(Date:11/24/2015)... 24, 2015 Capricor Therapeutics, Inc. ... the discovery, development and commercialization of first-in-class therapeutics, today ... Officer, is scheduled to present at the 2015 Piper ... a.m. EST, at The Lotte New York Palace Hotel ... . --> . ...
(Date:11/24/2015)... VILLAGE, Nev. , Nov. 24, 2015  PDL BioPharma, ... John P. McLaughlin , the company,s president and chief executive ... Jaffray Healthcare Conference next week in New York ... will occur on Tuesday, December 1, 2015 at 9:30 a.m. ... Presentations." Please connect to the website at least 15 minutes ...
(Date:11/24/2015)... ... November 24, 2015 , ... Whitehouse Laboratories is pleased to announce that ... facility will be strictly dedicated to basic USP 61, USP 62 and USP 51 ... to have complete chemistry and micro testing performed by one supplier. Management ...
(Date:11/23/2015)... Women with a certain type of lung nodule ... risk of lung cancer than men with similar nodules, according ... annual meeting of the Radiological Society of North ... --> Lung nodules are small masses of tissue ... based on their appearance on CT. Solid nodules are dense, ...
Breaking Biology Technology:
(Date:10/29/2015)... YORK , Oct. 29, 2015 ... technology, announced a partnership with 2XU, a global ... to deliver a smart hat with advanced bio-sensing ... and other athletes to monitor key biometrics to ... the strategic partnership, the two companies will bring together ...
(Date:10/27/2015)... BERLIN, Germany , October 27, 2015 ... 2015. SMI,s Automated Semantic Gaze Mapping technology (ASGM) automatically ... SMI,s Eye Tracking Glasses , so that ... Suite BeGaze. --> Munich, Germany ... technology (ASGM) automatically maps data from mobile eye tracking ...
(Date:10/26/2015)... India , October 26, 2015 ... --> adds ... 2015 to 2021 as well as ... 2015-2019 research reports to its collection ... . --> ...
Breaking Biology News(10 mins):