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eResearchTechnology, Inc. (eRT)
Clinical Cardiac Safety and Data Management Solutions
eResearchTechnology, Inc. (eRT) is a global provider of
cardiac safety services and electronic clinical data management solutions to the
pharmaceutical, biotechnology and medical device industries. eRT is a leading
centralized electrocardiographic (ECG) core laboratory providing cardiac safety
technology and services for clinical development in Phase I-IV. eRT is also a
leader in developing eClinical solutions focused on streamlining clinical trial
conduct by enabling the collection, analysis and distribution of all clinical
data.
Digital Collection, Analysis and Distribution of Cardiac
Safety Data
1. An enhanced EXPeRT® 2 , eRT’s market leading analysis
platform, is the heart of eRT’s operations providing scalable capacity and
flexible workflow processing in a secure and validated environment
2. Flexible capacity and throughput to support the
full-range of studies from single center to global, multi-center trials
3. eRT provides best-in-class 12-Lead Digital ECG devices
for standard cardiac safety or Holter collection utilizing Mortara and GE
Marquette ECG devices validated within EXPeRT
4. Full cardiac safety capabilities including best-practices
digital collection, transmission and processing plus paper ECG processing and
digital or paper rescue projects
5. SOP-driven, cross-functional Project Assurance
methodology encompasses pre-study planning, set-up, monitoring and close-out
activities which ensures effective study conduct and drives superior
performance metrics
6. Regulatory compliance excellence
7. Global, 24/7 customer care, logistics and site support
8. Industry leaders for Thorough QTc/ECG Trials (TQT/TET),
having completed significantly more than any other core lab
9. eRT Digital ECG Community provides on-demand data access
in a secure web platform in addition to flexible reporting options and XML waveform
viewing
10. eRT is an industry thought leader with experts available
to consult on medical and regulatory issues related to cardiac safety,
including protocol design and medical report writing
11. Global experience spanning 6 continents currently
supporting over 15,000 investigation sites
12. eRT has established partnerships across the clinical
services spectrum including partners in Japan and can facilitate assembly
of best-in-class cross-functional solutions
13. eRT works with a balanced customer base serving the
entire range of biopharmaceutical and emerging growth sponsors.
Clinical Data Solutions (eClinical)
eRT’s eClinical suite is a fully-supported, comprehensive
and simple clinical data management platform that provides full functionality
and services in support of clinical trials and directly integrates with EDC.
Key Applications
1. Clinical Information Portal (CIP)- eResearch
Community
2. Clinical Data Management System (CDMS)
3. Clinical Trial Management System (CTMS)
4. Adverse Event Reporting System (AERS)
5. Electronic Data Capture (EDC)
Key Features
1. One of the few that supports hybrid data entry
(paper/EDC)
2. EDC has zero footprint and requires only Internet
Explorer 6.0 or higher
3. eRT’s system supports both electronic query management as
well as paper query management issuing DCFs
4. The system can generate paper CRFs to be used as
templates for data entry for paper sites. The completed CRFs can also be printed from the system to PDF format and
burned onto a CD for record retention at the site. |
