We believe in getting it done right – the first time, every time.
Our rigorous process and emphasis on centralization aim to rule out data problems from the beginning. We employ our exclusive Project Assurance methodology to develop a planning roadmap at the start of every client project. This roadmap is a consistent framework through which we can efficiently manage the delivery of all cardiac safety services, from study initiation to completion. It also provides our clients with the standards, guidelines and services that allow us to effectively anticipate their needs and ensure proactive communication to meet and exceed their goals.
As a result, our clients' studies move along efficiently and accurately. We believe in getting it done right - the first time, every time.
Today, more and more studies involve global investigation sites for clinical trials. Running a logistically smart, global study calls for managing a large-scale inventory of validated and version-controlled equipment, as well as having a keen understanding of relevant requirements for customs clearance and physical hardware on a country-by-country basis. At ERT, we also understand various country-level transmission issues and infrastructure considerations, and are therefore able to provide the appropriate equipment and transmission solutions within a sponsor's budget and timeline parameters.
Digital 12-Lead ECG and Digital 12-Lead Holter (Phase I-IV)
At ERT, we apply best practices for 12-Lead digital ECG collection, transmission and processing. We also have solutions for recording and analyzing continuous 24-hour digital 12-Lead ECGs. Individual safety ECGs can be extracted and processed from these for interval duration measurements and cardiologist interpretation.
ERT provides the Mortara H12+ Digital Holter recorder. We validate all equipment provided using our EXPERT Technology Platform environment.
Holter Arrhythmia (Phase I-IV)
ERT offers solutions for recording continuous digital 6-Lead or 12-Lead ECGs to enable comprehensive, regulatory-grade arrhythmia analysis. Holter data reported by ERT is provided for quantifying heart rates, ventricular and supraventricular arrhythmias, and ischemia parameters, plus qualitatively reporting cardiac rhythm information.
Retrospective Paper and Digital
ERT provides centralized, high-resolution paper ECG processing. We have significant experience in "rescue" studies for analysis of both paper and digitally collected ECGs, often reprocessing ECGs collected in a decentralized manner. ERT solves data-variability problems from inconsistent ECG collection and evaluation methods, which are inherent in paper-based studies.
To avoid problems from the start, ERT recommends a digital, centralized approach, already common in most areas of clinical research. With the industry moving steadily away from paper-based methodologies, there has never been a better time to incorporate industry best practices by using digital ECGs for recording, transmitting, processing and reporting.
