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:2/5/2016)... SARASOTA, Florida (PRWEB) , ... February 05, 2016 , ... ... an event he has completed every year since it started in 2003. This year, ... attracting the attention of fellow runners and NBA team the Miami Heat. , This ...
(Date:2/5/2016)... ... February 05, 2016 , ... Successful recruitment and ... clinical and scientific initiatives have all marked the last 12 months at Roswell ... CEO of the nation’s oldest cancer center, Candace S. Johnson, PhD, outlined the ...
(Date:2/5/2016)... New York, New York (PRWEB) , ... February 05, 2016 , ... ... your life? The answer may be at the tips of your toes. Foot massage, ... benefits as well as pure comfort and relaxation. The American Board of Multiple ...
(Date:2/5/2016)... Rafael, CA (PRWEB) , ... February 05, 2016 , ... ... with ChildLight Yoga Studio in Dover, NH to direct high-performance kids yoga training. ChildLight ... New Hampshire’s seacoast, just one hour from Boston. , ChildLight Yoga Studio founder Lisa ...
(Date:2/5/2016)... ... February 05, 2016 , ... Give To Cure ... to search for and donate to Give To Cure’s campaign that is crowdfunding clinical ... lets users make and share payments through a smart device. In 2015 alone, Venmo ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... Feb. 4, 2016 Global Immunology Market ... to drive long-term market growth Summary ... of chronic disorders that affect 5–7% of western ... of their symptoms and key patient demographics, they ... immune pathways and an inappropriate immune response. Generally, ...
(Date:2/4/2016)... -- Omnicell, Inc. (NASDAQ: OMCL ), a leading provider of ... announced results for its fiscal year and fourth quarter ... --> GAAP results: Revenue for the fourth quarter ... 4.1% from the third quarter of 2015, and up ... 2014. Revenue for the year ended December 31, 2015 was ...
(Date:2/4/2016)...  Aethlon Medical, Inc. (Nasdaq: AEMD ), ... treat life-threatening diseases, today announced results for the ... 2015. --> --> ... our last quarterly call, we strategically advanced pre-clinical ... to establish the Aethlon Hemopurifier® as a leading ...
Breaking Medicine Technology: