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This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies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The webinar will also cover methods to adopt the draft guidance’s recommended changes in risk-based monitoring, including a review of statistical mechanisms to select forms for Source Document Verification (SDV), as well as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:11/25/2015)... , November 25, 2015 ... Report is a professional and in-depth study on ...      (Logo: ) , ... the industry including definitions, classifications, applications and industry ... for the international markets including development trends, competitive ...
(Date:11/24/2015)... , Nov. 24, 2015 Halozyme Therapeutics, Inc. (NASDAQ: ... in New York on Wednesday, December 2 ... Torley , president and CEO, will provide a corporate overview. ... York at 1:00 p.m. ET/10:00 a.m. PT . ... relations, will provide a corporate overview. --> th ...
(Date:11/24/2015)... -- Clintrax Global, Inc., a worldwide provider of clinical research services headquartered ... the company has set a new quarterly earnings record in Q3 ... posted for Q3 of 2014 to Q3 of 2015.   ... , with the establishment of an Asia-Pacific ... United Kingdom and Mexico , with ...
(Date:11/24/2015)... 2015 --> ... released by Transparency Market Research, the global non-invasive prenatal ... of 17.5% during the period between 2014 and 2022. ... Industry Analysis, Size, Volume, Share, Growth, Trends and Forecast ... market to reach a valuation of US$2.38 bn by ...
Breaking Biology Technology:
(Date:11/9/2015)... 2015 ... "Global Law Enforcement Biometrics Market 2015-2019" ... ) has announced the addition ... Market 2015-2019" report to their offering. ... ) has announced the addition of ...
(Date:11/2/2015)... Calif. , Nov. 2, 2015  SRI International ... million to provide preclinical development services to the National ... contract, SRI will provide scientific expertise, modern testing and ... variety of preclinical pharmacology and toxicology studies to evaluate ... --> The PREVENT Cancer Drug Development Program ...
(Date:10/29/2015)... 2015 Daon, a global leader in mobile ... a new version of its IdentityX Platform , ... America have already installed IdentityX v4.0 and ... FIDO UAF certified server component as an ... FIDO features. These customers include some of the largest ...
Breaking Biology News(10 mins):