Navigation Links
eC-SSRS Solution from ERT Facilitates Compliance with New FDA Guidance on Suicidality Assessment in Clinical Trials
Date:1/5/2011

PHILADELPHIA, Jan. 5, 2011 /PRNewswire/ -- ERT (Nasdaq: ERES  - News), a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced that its eC-SSRS (Electronic Columbia Suicide Severity Rating Scale) solution facilitates compliance with the newly introduced Food and Drug Administration (FDA) guidance document entitled "Suicidality: Prospective Assessment of Occurrence in Clinical Trials."  A copy of this guidance can be downloaded from www.ert.com.

The recently released FDA guidance document is intended to assist sponsors in assessing the occurrence of treatment-related suicidality in clinical trials or drug and biological products. The guidance highlights the increasingly recognized importance of suicidality assessment in psychiatric and non-psychiatric drug trials and provides general principles for how best to achieve effective assessment during the drug development process. The document highlights the Columbia Suicide Severity Rating Scale (C-SSRS), which comprises a detailed interview as an approved assessment instrument. The guidance intends to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the academic community and the public.

ERT's eC-SSRS is an electronic self-rated version of the C-SSRS, which was developed in collaboration with the scale authors and provides a cost-effective method of proactively monitoring suicidality for trial sponsors. The solution was designed in anticipation of the FDA recommendations outlined in the newly released guidance document. Using interactive voice-response technology validated against the C-SSRS, the eC-SSRS is a fully structured interview providing standardized questions, relevant follow-up questions, error-handling routines a
'/>"/>

SOURCE ERT
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Pharmacists Encourage Americans to Consider Medicine Cabinet Cleanout Among New Years Resolutions
2. Mindray Medical Announces Shareholder Resolutions Adopted at 2010 Annual General Meeting
3. Advanced Laser Therapy Solutions for Womens Hair Loss
4. ERT Unveils Full Range of ePRO Solutions Providing the Power of Choice for Clinical Trial Sponsors
5. TransTech Medical Solutions Expands Offering to MD Anderson Cancer Center to Include Outsourced Medical Transcription and Editing Services
6. Innovative Clinical Solutions, Ltd. Announces Second and Final Liquidating Cash Distribution
7. MedShape Solutions, Inc. Secures Investment From IQT to Support U.S. Intelligence Community
8. Streamline Health Solutions Reports Q3 Results
9. Texas-Based Healthcare Delivery System Expands Utilization of Streamline Health Document Workflow Solutions
10. Streamline Health Solutions Enables Electronic Medical Records System for Leading Canadian Healthcare Provider
11. Chilean Companies Show Innovative Solutions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/14/2014)... DIEGO , July 14, 2014  Diomics, ... material, today announced that the United States Patent ... held by Diomics covering novel biologic sample collection ... their use in forensics and diagnostics. ... materials is by swabbing. Recovery of DNA from ...
(Date:7/14/2014)... ANAHEIM, Calif. , July 14, 2014  Mallinckrodt plc ... QCOR ) today announced that the registration statement ... Commission ("SEC") by Mallinckrodt plc on May 16, 2014 and ... statement of Mallinckrodt and Questcor that also constitutes a prospectus ... registration statement on Form S-4 is available on the SEC,s ...
(Date:7/14/2014)... Francisco, Calif. , July 14, 2014 ... today announces a technology partnership with global ... develop its technology for quick-to-market products. ... approach and DNA2.0,s machine learning optimization technologies, ... speeding up the process of engineering proteins ...
Breaking Medicine Technology:Diomics Announces Issuance Of U.S. Patents For Novel Biologic Sample DNA Collection Materials For Use In Forensics And Diagnostics 2Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 2Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 3Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 4Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 5Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 6Mallinckrodt Pharmaceuticals And Questcor Pharmaceuticals Provide Update On Transaction 7Pareto Biotechnologies Announces Technology Partnership With DNA2.0, Inc. 2Pareto Biotechnologies Announces Technology Partnership With DNA2.0, Inc. 3
... 30 A 17-year-old female with a complex ... in India to be treated using the fast Novalis Tx(TM) ... VAR ) and BrainLAB. Doctors at Kokilaben Dhirubhai Ambani Hospital ... single session that took just a few minutes to complete. ...
... Life Spine announced today that the U.S. Food ... to the SENTINEL Occipito-Cervico-Thoracic (OCT) System. , The ... from the occiput to thoracic spine, and features streamlined ... are available in multiple diameters and lengths, and offer ...
Cached Medicine Technology:Pioneering Brain Malformation Treatment Performed Using Novalis Tx(TM) Radiosurgery Technology in India 2Pioneering Brain Malformation Treatment Performed Using Novalis Tx(TM) Radiosurgery Technology in India 3Pioneering Brain Malformation Treatment Performed Using Novalis Tx(TM) Radiosurgery Technology in India 4
(Date:7/14/2014)... Germany (PRWEB) July 14, 2014 EurekaMag.com ... Hepatitis C which is a contagious liver disease ... a few weeks to a serious, lifelong illness that ... the United States have chronic Hepatitis C virus infection ... While the site's research category covers all studies ...
(Date:7/14/2014)... 14, 2014 According to ... review recently updated by Vkool.com, this is ... wide range of simple and easy tips ... including:,     Increasing omega-3 fatty ... products ,     Increasing fiber , ...
(Date:7/14/2014)... 14, 2014 Carepoint has been ... caregiving by combining an intuitive interface for recording, ... robust service tracking and reporting features. , Hall ... has teamed up with Rebecca de Witte to ... healthcare organizations. , Carepoint provides seamless, ...
(Date:7/14/2014)... 14, 2014 Vaginal Mesh lawsuit ... seven different pelvic mesh manufacturers in the U.S. District ... Schulte LLC. The federal complaints are pending against pelvic ... American Medical Systems (MDL No. 2325), and C.R. Bard, ... are 58,262 Vaginal Mesh lawsuit claims pending, according to ...
(Date:7/14/2014)... DC (PRWEB) July 14, 2014 ... exchanges, carriers emphasized lower-cost narrow-network products, accountable care ... generally chose coverage based on price, rather than ... enrollees from seeking care from out-of-network providers. ... ACOs, Narrow Networks and Exchange Products,” the ...
Breaking Medicine News(10 mins):Health News:EurekaMag.com Publishes 64,900 New Studies on Hepatitis C 2Health News:Endometriosis Bible and Violet Protocol Book Review Exposes Zoe Brown's Endometriosis Treatment Guide – Vkool.com 2Health News:Endometriosis Bible and Violet Protocol Book Review Exposes Zoe Brown's Endometriosis Treatment Guide – Vkool.com 3Health News:Home Health Care Professional and Marketing Firm Team Up to Create New Homecare Communication App 2Health News:Nearly 60,000 Vaginal Mesh Lawsuit Claims Filed Against Seven Different Pelvic Mesh Manufacturers 2Health News:Nearly 60,000 Vaginal Mesh Lawsuit Claims Filed Against Seven Different Pelvic Mesh Manufacturers 3Health News:Nearly 60,000 Vaginal Mesh Lawsuit Claims Filed Against Seven Different Pelvic Mesh Manufacturers 4Health News:Nearly 60,000 Vaginal Mesh Lawsuit Claims Filed Against Seven Different Pelvic Mesh Manufacturers 5Health News:Milliman, FAIR Health Executives to Discuss Data-Based Rate Setting for Out-of-Network Providers in Atlantic Information Services Webinar 2
... ... don,t need the pretty bottles or sweet aroma of fragrant lotions and cleansers-men ... tailored specifically to a man,s needs without added synthetic ingredients that may be ... uses the purity of nature to enhance the skin,s surface and makes a ...
... ... Drive in Beverly Hills to Main Street in small towns across America. The medical community ... growing epidemic. , ... PA (PRWEB) June 1, 2010 -- Nearly 7 million Americans are abusing prescription drugs – ...
... ... Harmful Bacteria, Including MRSA. Jan-Pro, Global Leader in Commercial Cleaning, Once Again Leads the ... Offer Powerful New Solution in the control of infectious microorganisms - EnviroShield Disinfectant Technology ... (PRWEB) June ...
... ... of a novel combination of two FDA Approved topical medications. This triple blind controlled ... ... Oscar Klein M.D. today announced the results of a triple blind hair loss research study ...
... ... a brand new buy back plan. , ... (PRWEB) – CosmeticLaserWorld.com ( www.cosmeticlaserworld.com ), a market leader in ... should purchase equipment from the reseller. Under an Investment Protection Plan, the company will ...
... - Shionogi Pharma, Inc., a U.S.-based group company of ... results of two pivotal studies of the investigational new ... for the treatment of primary premature ejaculation (PE). These ... (AUA) Annual Meeting in San Francisco. Evaluating a ...
Cached Medicine News:Health News:Garden of Eve Launches a Father's Day Tribute for Men Who Want to Look Well-groomed with Little Fuss 2Health News:Garden of Eve Launches a Father's Day Tribute for Men Who Want to Look Well-groomed with Little Fuss 3Health News:Garden of Eve Launches a Father's Day Tribute for Men Who Want to Look Well-groomed with Little Fuss 4Health News:Medical Community Responds to Prescription Drug Abuse 2Health News:Medical Community Responds to Prescription Drug Abuse 3Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 2Health News:JAN-PRO Launches Exclusive “EnviroShield™” Disinfecting System - Kills Harmful Bacteria, Including MRSA 3Health News:Hair Loss Research Study Reveals Important Breakthrough in the Treatment of Male Pattern Baldness 2Health News:Hair Loss Research Study Reveals Important Breakthrough in the Treatment of Male Pattern Baldness 3Health News:CosmeticLaserWorld.com Gives Buyers Peace of Mind Through Industry-Leading Investment Protection Plan 2Health News:Pivotal data for the investigational treatment PSD502 for primary premature ejaculation 2Health News:Pivotal data for the investigational treatment PSD502 for primary premature ejaculation 3
High resolution, multi-frequency, HST version of the UST-987-7.5. Provides even greater image detail, better resolution, and penetration....
... Penetration Steered Linear Peripheral Vascular transducer, with ... MHz. It is our newest vascular ... 4 different settings to optimize imaging of ... color and Doppler sensitivity of this transducer ...
... Super High Density, multi-frequency, linear ... "twist on the UST-5536, this ... it sweeps horizontally as well ... axis so that target lesions ...
... The UST-MC11-8731 is a perfect alternative ... are used to seeing more of a ... of the transducer in the hand., This ... shaped convex intraoperative transducer. The UST-MC11-8731 nestles ...
Medicine Products: