Navigation Links
Challenges and Opportunities in Risk-Based Monitoring, New Webinar Hosted by Xtalks
Date:3/1/2013

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This webinar will examine highlights of the draft guidance issued in late 2011 by the FDA entitled: “A Risk-based Approach to Monitoring” and will provide examples of potential cost savings and increased efficiencies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The webinar will also cover methods to adopt the draft guidance’s recommended changes in risk-based monitoring, including a review of statistical mechanisms to select forms for Source Document Verification (SDV), as well as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:

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

Page: 1 2

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:
*Name:
*Comment:
*Email:
(Date:11/24/2014)... , Nov. 24, 2014  IGI Laboratories, Inc. ... based specialty generic pharmaceutical company, today announced it ... to the U.S. Food and Drug Administration (FDA), which ... 2014 to seven, with eighteen submissions now pending at ... President and CEO of the Company, commented, "Our team ...
(Date:11/24/2014)... SOUTH SAN FRANCISCO, Calif. , Nov. 24, 2014 /PRNewswire/ ... announced that Bonnie H. Anderson , president and chief ... the Piper Jaffray 26 th Annual Healthcare Conference on ... New York . The live audio ... website at http://investor.veracyte.com . Please connect to the website ...
(Date:11/24/2014)... 2014  Spherix Incorporated (Nasdaq: SPEX ... fostering and monetization of intellectual property, today provided ...  Case No. 3:13-cv-03494-M and  Spherix v. Uniden Corporation ... the United States District Court for the Northern ... On November 21, 2014 the Markman ...
(Date:11/22/2014)... Prominent academics, leaders of the ... December 3rd at Genetic Rx, a networking conference ... take place at the Joseph B. Martin Conference ... the present and future of genetic medicines—including siRNA, ... editing—as well as the treatment of patients with ...
Breaking Biology Technology:IGI Laboratories, Inc. Announces ANDA Submission 2Veracyte to Present at the Piper Jaffray 26th Annual Healthcare Conference 2Markman Hearing Held as Scheduled in VTech and Uniden Cases 2Pioneering Academics and Key Industry Leaders to Discuss Rare Diseases and the Emergence of New Genetic Medicines at Genetic Rx on December 3rd 2
... May 5 Silence Therapeutics plc (AIM: ... Jorg Kaufmann , Ph.D., to the position of ... Kaufmann, who previously served as senior director, technologies at ... Company,s broad range of RNA interference (RNAi) research activities, ...
... Healthcare ... Finance and Administration. Mr. Wilson brings over 25 years experience in this field and ... ... Mitchell Wilson has joined the company as Vice President of Finance and Administration. Mr. ...
... Inc. (Nasdaq: ITMN ) today announced that the U.S. Food and ... Application (NDA) for Esbriet™ (pirfenidone) for the treatment of patients with idiopathic ... , , ... the FDA,s Center for Drug Evaluation and Research when the review of ...
Cached Biology Technology:Silence Therapeutics Appoints New Vice President of Research 2Silence Therapeutics Appoints New Vice President of Research 3Healthcare Data Solutions Announces New Executive Team Member 2InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application 2InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application 3InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application 4InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application 5
(Date:11/4/2014)... death at the right time might actually help boost ... could help in understanding animal populations, pest control and ... in the journal Trends in Ecology and Evolution ... that the kind of positive population effect an overall ... depends on the size and developmental stage of the ...
(Date:11/4/2014)... 4, 2014) — Think about the way our bodies ... neighboring cells know that they are supposed to become ... these tissues find the correct place and alignment? Researchers ... crucial questions. , In a new study, UM researchers ... with their surrounding neighbors, at the head-trunk region. Their ...
(Date:11/4/2014)... OXFORD, England , November 4, 2014 ... expansion and vertical market growth   Fuel3D ... it has closed a funding round totaling $6.4 million (£4 ... (£1.6 million) funding secured earlier this year and paves the ... product in 2015. The funding round was led ...
Breaking Biology News(10 mins):When less is more: Death in moderation boosts population density in nature 2The inside story: How the brain and skull stay together 2Fuel3D Secures $6.4 Million in Expansion Funding 2Fuel3D Secures $6.4 Million in Expansion Funding 3
... article by Stevens Institute of Technology researchers featured as ... Volume 98, Issue 7 represents a step forward in ... Dr. Chang-Hwan Choi and Dr. Eui-Hyeok (EH) Yang, and ... focuses on nanowires, structures that are mere nanometers in ...
... Ga., Feb. 23, 2011 MiMedx Group, Inc. (OTC ... manufacturer and marketer of patent protected biomaterial-based products, announced ... full year ended December 31, 2010, and Company guidance ... on Monday, March 28, 2011.  The timing of the ...
... awarded a prestigious Sloan Research Fellowship. Chen, a Canada ... subject: deciphering the assembly instructions for the brain. ... with precision. One of the central puzzles in neuroscience ... during its development when faced with thousands of potential ...
Cached Biology News:Nanowire research at Stevens makes cover of Applied Physics Letters 2MiMedx Group, Inc. Announces Release Date for 2010 Fourth Quarter and Full Year Results 2Prestigious Sloan Fellowship awarded 2
... Instech Solomon's laboratory animal infusion kits reduce ... an infusion study while providing sterile equipment ... kit includes everything you need for one ... Tubing and tethers will be cut to ...
... Plus is a small and ... market for both LC and IC. It ... Atmospheric Pressure Ionization (API) source for outstanding ... is compatible with existing LC and IC ...
Kit for BASE20/50 dual control unit, includes mounting plate, HOLDER50T, HEATERPAD50, SRTDX temperature probe(s)....
...
Biology Products: