Free press releases distribution network?

Agency / Source: The Scott Partnership

Check Ads Availability|e-mail Article


Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!



ERT Announces A New Self-Rated Version of the C-SSRS - Facilitating Prospective Suicidality Monitoring - ERT (NASDAQ: ERES), announces a pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements
ERT Announces A New Self-Rated Version of the C-SSRS - Facilitating Prospective Suicidality Monitoring

 

PRZOOM - /newswire/ - Philadelphia, PA, United States, 2010/03/15 - ERT (NASDAQ: ERES), announces a pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements.

   
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

The validated eC-SSRS solution, developed in collaboration with the scale lead author, is a cost-effective method of prospectively monitoring for suicidality. It has been designed, in line with anticipated FDA requirements, to reliably and reproducibly assess suicidality in clinical trials; thereby, protecting patient safety while significantly reducing the burden on study sites.

In recent years, there has been increased focus on treatment-emergent suicidality and the development of a reliable assessment method for use in clinical trials to enhance effective patient-safety monitoring. The FDA is developing guidance on regulatory requirements for suicidality monitoring. In light of concerns regarding the burdens placed on investigators, ERT, in collaboration with the scale authors, the Center for Suicide Risk Assessment (CSRA) and Healthcare Technology Systems, developed the eC-SSRS.

Kelly Posner, Director of the CSRA at Columbia University and primary author of the C-SSRS, comments: "The FDA Division of Psychiatry Products has indicated that C-SSRS is an acceptable prospective suicidality monitoring assessment. As primary author of the Columbia-Suicidality Severity Rating Scale (C-SSRS), I believe the eC-SSRS is a faithful and accurate representation of the interview version of C-SSRS and has been carefully designed to produce consistent outcomes."

The eC-SSRS is an electronic self-rated version of the C-SSRS using interactive voice-response technology that has been validated against the C-SSRS. The eC-SSRS is a fully-structured C-SSRS interview comprised of standardized questions, appropriate follow-up questions, error-handling routines and scoring conventions. Similar to the C-SSRS, the eC-SSRS assesses lifetime suicidality during an initial baseline evaluation and then monitors ideations and behaviors at subsequent study visits. This solution allows for timely identification of potential risks and provides prompt feedback to study sites for follow-up and evaluation.

Dr. John Greist, CEO of Healthcare Technology Systems and an eC-SSRS author, commented that the FDA Division of Psychiatric Products (FDA/DPP) has confirmed that they would like to see prospective suicidality monitoring during each visit in every trial, in all development phases after Phase I.
The C-SSRS has been identified by the FDA as the only acceptable assessment instrument currently available for monitoring suicidal ideations and behaviors in clinical trials. Dr. Greist said, "The FDA/DPP has indicated that questions regarding the acceptability of the eC-SSRS can be directed to them by letter as part of a formal inquiry to the Division."

The eC-SSRS has been successfully used in a validation study sponsored by a major pharmaceutical company, using psychiatric inpatients and healthy control volunteers. The results demonstrated convergent validity of the eC-SSRS with the Beck Suicide Scale. In addition, inter-rater reliability between the eC-SSRS and human C-SSRS raters was comparable to reliabilities found between the human raters. The study also demonstrated good criterion validity of the eC-SSRS for discriminating known-groups differences between the study samples. Overall, the eC-SSRS displayed its feasibility, reliability and validity for assessing suicidality prospectively.

Michael Federico, Vice President, ePRO Solutions at ERT, explains: "In the history of drug development, every time a new regulation is introduced, the burden falls to the investigator sites. This validated eC-SSRS solution reduces this additional site burden. eC-SSRS is now supporting several ongoing clinical trials in large and mid-sized pharmaceutical companies."

For further information on ERT and its technology and services, please email info[.]ert.com, call +1 215 972 0420.

For further press information, please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom. P: +44 1477 539539, F: +44 1477 539540, E: ert[.]scottpr.com.

About ERT

Based in Philadelphia, PA, ERT (eResearchTechnology, Inc.) is a global provider of technology and services to the biopharmaceutical, medical device, and related industries. The Company is the market leader in providing centralized core-diagnostic electrocardiographic (ECG) technology and services to evaluate cardiac safety in clinical development. The Company also provides technology and services to streamline the clinical trials process by enabling its customers to automate the collection, analysis, and distribution of clinical data in all phases of clinical development.

Statements included in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties, which could cause actual results to differ materially from those expressed or implied from such statements. These risks and uncertainties include, without limitation, the Company's ability to obtain new contracts, variability in size, scope, and duration of projects, integration of acquisitions, competitive factors, technological development, market demand, and other factors described in the Company's filings with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

 
 
Your Banner Ad Here instead - Showing along with ALL Articles covering Medical Services/Equipment Announcements

Replace these Affiliate Programs at ANYTIME! Your banner here within the next hour. Learn How!


 

Agency / Source: The Scott Partnership

 
 

Availability: All Regions (Including Int'l)

 

Traffic Booster: [/] Quick PRZOOM - Press & Newswire Visibility Checker

 

Distribution / Indexing: [+]

 
 
# # #
 
 
  Your Banner Ad showing on ALL
Medical Services/Equipment articles,
CATCH Visitors via Your Competitors Announcements!


ERT Announces A New Self-Rated Version of the C-SSRS - Facilitating Prospective Suicidality Monitoring

Company website links NOT available to basic submissions
It is OK to republish and/or LINK any newswire for any legitimate media purpose as long as you name PRZOOM - Press & Newswire and LINK as the source.
 
  For more information, please visit:
Is this your article? Activate ALL web links by Upgrading to Press Release PREMIUM Plan Now!
|
Contact: Fiona Robinson 
+1 215 972 0420 info[.]ert.com
 
PRZOOM / PRTODAY - Newswire Today disclaims any content contained in this article. If you need/wish to contact the company who published the current release, you will need to contact them - NOT us. Issuers of articles are solely responsible for the accuracy of their content. Our complete disclaimer appears here.
IMPORTANT INFORMATION: Issuance, publication or distribution of this press release in certain jurisdictions could be subject to restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with the applicable rules and regulations in the particular jurisdiction. This press release does not constitute an offer or an offering to acquire or subscribe for any The Scott Partnership securities in any jurisdiction including any other companies listed or named in this release.

Medical Services/Equipment via RSSAdd NewswireToday - PRZOOM Headline News to FeedBurner
Find who RetweetFollow @NewswireTODAY



Are you the owner of this article?, Turn it PREMIUM with your LOGO instead - and make it 3rd party Ads-Free! within the next hour!




Read Latest Press Releases From The Scott Partnership / Company Profile


Read Medical Services/Equipment Most Recent Related Press Releases:

Frost & Sullivan Lauds SnooZeal’s Unique Electrical Stimulation Therapy for Sleep Apnea in the European Market
ZOLL Expands the Rescuer Experience at EMS Today
Traditional Mass Spectrometers Give Way to High-resolution Technologies Such as MALDI-TOF Finds Frost & Sullivan
AccuVein, Inc. Named A Best Place to Work in Medical Sales for Second Consecutive Year
Ansell Limited Acquires Cleanroom and Healthcare Consumables Manufacturer Nitritex Limited
ZOLL to Showcase Expanded Portfolio of Advanced Resuscitation and Acute Critical Care Technologies at Arab Health 2017
Frost & Sullivan Awards Ansell for Entrenching itself in the Hand Protection Market with its Visionary Products and Technologies
ZOLL RescueNet ePCR Achieves Latest National Compliance Standard
Eye Tech Care Wins Top Honours from Frost & Sullivan for Developing the EyeOP1, the Only Computer-assisted System for Glaucoma Therapy
Frost & Sullivan Recognizes Nuvectra’s Pioneering Spinal Cord Stimulation Product for Chronic Pain Management

Boost Your Social Network
& Crowdfunding Campaigns


LIFETIME SOCIAL MEDIA WALL
 
NewswireToday Celebrates 10 Years in Business
Find business coaching, life coaching, executive coaching and corporate coaching, best selling coaching books, ...



PREMIUM Members


Visit  La Bella Bakery Artisan Bakery Arizona

Visit  BizJobs.com

Visit  JobsWare.com







 
  ©2017 PRZOOM — Limelon Advertising, Co.
Home | About PRZOOM | Advertise/Pricing | Contact | Investors | Privacy/TOS | Sitemap | FRANCAIS
newswire, PR free press releases distribution service magazines engine news alert newsroom press room breaking news public relations articles company news alerts newswiredistribution ezine bizentrepreneur biznewstoday digital business report market search pr firms agencies reports distri-bution today investor relation successful internet entrepreneur newswire distribution prtoday.com freenewswiredistribution asianewstoday bizwiretoday USA pr UK today