Navigation Links
ERT Announces AVERT™ for Suicide Risk Assessment in Clinical Development
Date:6/20/2013

Philadelphia, PA (PRWEB) June 20, 2013

ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced enhancements to AVERT™, its proven electronic suicide risk assessment system. Having already been used by over 32,000 clinical trial patients, AVERT is now available in both audio (phone) and visual (web/tablet) patient interfaces, offering greater flexibility to developers of new biopharmaceutical products.

Having captured over 100,000 assessments to date, AVERT is a proven and reliable tool for biopharmaceutical developers who need to assess for suicide risk during clinical development programs. Carl Gommoll, Sr. Director Clinical Development at Forest Research Institute stated, “It is critical for us to understand the complete safety profile of new drugs in development, especially if during the course of a trial, patients experience suicidal ideation and behaviors. By administering AVERT we feel we are taking the most comprehensive and effective approach to identify the emergence of suicidal ideation and behaviors in order to enhance patient safety, which is our highest priority.”

Biopharmaceutical developers face the risk of treatment-emergent suicidal ideation and behavior (SIB) occurrence among patients in clinical trials. As a result of this safety risk, in 2012 the U.S. FDA issued a revised Draft Guidance for Prospective Assessment of SIB in psychiatric and non-psychiatric trials. The guidance requires researchers in high-potential SIB risk areas to develop and follow study protocols that proactively assess SIB risk and enable proper behavioral health treatment for at-risk patients.

AVERT presents electronic administration of scientifically proven suicide risk assessment questionnaires. Its current application is delivered through an electronic patient self-rated version of the Columbia Suicide Severity Rating Scale (eC-SSRS), which is cited in the FDA guidance as an acceptable instrument for assessing SIB. By using AVERT, clinical trial patients can comfortably and confidentially respond to a brief, SIB-related interview during investigative site visits or from home. If AVERT identifies an at-risk patient, the investigative site is alerted immediately, enabling them to take appropriate action per the protocol.

“We are passionate about finding ways to help researchers protect their patients, and their new products in development,” said Jeffrey Litwin, M.D., CEO of ERT. “We are pleased to offer an enhanced version of AVERT that can be administered in a mode most comfortable for the patient, making the assessment of SIB risk more efficient and reliable for biopharmaceutical developers. By combining leading technology with good science we can continue to help improve clinical research and improve patient safety.”

AVERT’s patient self-rated interviews deliver more reliable data than traditional clinician administered interviews by reducing the risk of patient non-disclosure and assessor variability. Continuing its scientific collaboration with C-SSRS author Dr. Kelly Posner and leading industry psychiatrist, Dr. John Greist, ERT has enhanced the application to identify the recency of suicidal thoughts and actions. This system enhancement focuses the investigative site’s attention on any troubling responses regarding recent events that require follow-up by a mental health professional.

Overall, investigative sites benefit from these complete, consistent assessments and reporting, as well as from reduced staff burden. By utilizing AVERT, clinical trial sponsors gain greater visibility into patient safety and increased confidence in meeting the FDA guidance on SIB. The resulting reliable and high-quality data allows sponsors and regulators to document the drug’s true effect on suicidal ideation and behaviors.

For more information on AVERT, please visit http://www.ert.com/suicide-risk-assessment.

About ERT
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle. ERT delivers the most widely deployed solutions in centralized cardiac safety, respiratory services, suicide risk assessment and Clinical Outcome Assessments (COA) – which includes patient, clinician, and observer reported outcomes. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes, and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., U.K., Japan, and Germany.

Read the full story at http://www.prweb.com/releases/2013/6/prweb10834701.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. AFAR announces the 2012 Hartford Centers of Excellence in Geriatric Medicine awards
2. Bascom Palmer Eye Institute announces breakthrough for degenerative vision disorder
3. University of Houston Graduate College of Social Work announces partnership with MD Anderson
4. The Ludwig Institute for Cancer Research announces launch of iTeos Therapeutics SA
5. AGA announces prestigious awards recognition recipients
6. TheBestHeartRateMonitorReviews.com Announces The Top 3 Heart Rate Monitors
7. Article Marketing Company Content Writing King Announces Training Of New Graphic Design Artist
8. Zane Benefits Announces Wellness HRAs: A New Way to Reward Healthy Employees
9. San Francisco’s Advanced Male Medical Center Announces Discount, Discusses Erectile Dysfunction
10. Insulite Labs announces the launch of the PCOS Inspiration Hour, a one hour virtual gathering place for women with PCOS and other women’s health issues to come together.
11. NYC Doc Announces 3 Surprising Ways to Beat Seasonal Allergies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their ... Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... Pro X users can now reveal the media of their split screens with ...
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... North Carolina (PRWEB) , ... June 26, 2016 , ... ... release of a new product that was developed to enhance the health of felines. ... for centuries. , The two main herbs in the PawPaws Cat Kidney Support ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Story Highlights: ... the health care industry is causing providers to review ... Deloitte offers a suite of solutions for health care ... cost optimization: labor resource analysis, revenue cycle optimization and ... outcomes and better economics ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
Breaking Medicine Technology: