Navigation Links
ERT Reaches Milestone in Supporting Successful New Drug Approvals
Date:1/8/2014

Philadelphia, PA (PRWEB) January 08, 2014

ERT, a leading global solution provider for high-quality patient safety and efficacy endpoint data collection, today announced it has reached a significant milestone in capturing important data to support the approval of new medical products. To date, global regulatory agencies have issued over 300 approvals to biopharmaceutical companies that relied on ERT’s cardiac safety, respiratory, or eCOA solutions to capture critical safety and/or efficacy data in their clinical programs.

In order to receive regulatory approval of new medical treatments, biopharmaceutical companies must first demonstrate the product’s safety and efficacy through a series of controlled clinical trials. ERT’s suite of products and services for cardiac safety, respiratory, and eCOA – which include electronic patient reported outcomes (ePRO) – are repeatedly relied upon for capturing these important data.

"It is extremely rewarding to realize that so many biopharmaceutical companies have brought new medical treatments to market using products and services delivered by ERT," said Jeffrey Litwin, M.D., CEO of ERT. "We are committed to delivering innovative and reliable solutions that meet the needs of our worldwide customers and supporting their efforts to bring life-enhancing and life-saving medical products to patients who need them."

ERT is sharing its knowledge of supporting regulatory approvals by offering a complimentary white paper entitled "ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes." This paper reviews ERT’s experiences in supporting and participating in ePRO regulatory inspections by the U.S. FDA, European Medicines Agency (EMA), specifically BfArM (German Federal Institute for Drugs and Medical Devices), and the Japanese Pharmaceutical and Medical Devices Agency (PMDA), and outlines best practices for minimizing risk in preparation for regulatory inspections of ePRO data collection systems. The paper is available for complimentary download at http://www.ert.com/clinical/resources/white-papers/.

For additional information on ERT’s proven cardiac safety, respiratory, and eCOA products and services, visit http://www.ert.com/clinical/clinical-endpoints/.

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/2014/01/prweb11470975.htm.


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

Related medicine news :

1. Fit Brains, online portfolio of cognitive games, reaches milestone of 75 million brain scores
2. DefenderPad™ Reaches a New Milestone: Global Sales Penetration
3. Bridges to Recovery Reaches Ten-Year Milestone as Premiere, Licensed Residential Behavioral Treatment Program and Honors Founding Medical Director Dr. Terry V. Eagan
4. Prescription overdose rate reaches epidemic levels in NYC
5. Society of Interventional Radiology: Pioneering specialty reaches out
6. Portable fitness workout solution iTRAIN Body Makeover Weight-Loss package reaches 500,000 downloads
7. Tanzania’s Healthy Pregnancy Text Message Service Reaches 100,000 Subscribers in 15 Weeks
8. Northern Westchester Hospital Surgeon Reaches New Single-Incision Robot-Assisted Gallbladder Removal Surgery Milestone
9. Zamansky & Associates LLC Investigates Chemed Corporation For Possible Securities Law Violations And Breaches Of Fiduciary Duties To Shareholders
10. DiscountMedicalSupplies.com Reaches Out to More People in Need of Low-Price Medical Supplies Through Valpak
11. High Bit Security: 2/3 of All Data Breaches Preventable With Proactive Security Testing, New Ponemon Institute Study Documents Breach Causes and Costs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are confused ... endometriosis. These women need a treatment plan to not only alleviate symptoms and ... help for preservation of fertility and ultimately achieving a pregnancy. The specialists at ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
Breaking Medicine Technology: