microconstants > ourservices > Clinical Trial Service > Cardiac safety research and eCOA tool

Cardiac safety research and eCOA tool

2017-02-21 14:24:40
MicroConstants China has established partnership with eResearch Technology (ERT), a global leader in providing high quality patient safety and efficacy endpoint data collection solutions for clinical drug development, to provide marketing and in-country support in Greater China region for ERT's.cardiac safety studies and eCOA studies. MicroConstants China assists ERT with project assurance functions, including logistics support, first line of support (help desk), bilingual presentation at IM meetings, and on-site training, that are necessary to ensure proper use of ERT equipment.
 
Centralized Cardiac Safety Solutions 
 
ERT provides for the collection, interpretation and distribution of ECG data and images during clinical trials in all phases of the clinical research process. ECGs are administered at the local investigation site using a standard set of protocols and homogenous equipment. The digital ECG data is then transmitted to the ERT centralized cardiac safety laboratory where it is subject to a standardized set of operational processes. ERT’s Cardiac Safety solutions, including its proprietary EXPERT® technology platform, provide for workflow-enabled cardiac safety data collection, interpretation and distribution of ECG data and images as well as for analysis and cardiologist interpretation of ECGs performed on research subjects in connection with our customers’ clinical trials. 
 
As part of ERT’s Cardiac Safety solutions, ERT offers continuous digital 12-lead ECG recording and longer-term Holter recording devices. For continuous digital 12-lead ECG recording, the 12-lead ECG signals are recorded onto compact flash memory cards and submitted to ERT for processing. ERT’s Cardiac Safety solutions also include Extensible Mark-up Language (XML) data delivery, which provides for the delivery of ECGs in a format compliant with the United States Food and Drug Administration’s XML standard for digital ECGs for submission to the FDA ECG Warehouse. ERT also provides ECG equipment through rental and sales to customers to perform the ECG recordings and give them means to send such recordings to ERT. ERT’s portal product, MyStudyPortal™, provides sponsors and investigator sites with the ability to order supplies, gain real time reports and respond to queries via a secure web portal. 
 
Electronic Clinical Outcomes Assessments (eCOA) 
 
ERT offers solutions for the electronic capture of self- reported data from patients, clinicians and caregivers that directly or indirectly measure how patients feel or function and can be used to determine whether or not a drug has been demonstrated to provide a treatment benefit. These solutions are referred to as patient reported outcomes (PRO), clinician reported outcomes (ClinRO) and observer reported outcomes (ObsRO). ERT also offers an intelligent suicide monitoring and prevention program (AVERT™). ERT’s eCOA solutions offer higher quality data with accurate timestamps and real-time data access for logical branching and edit checks to confirm data accuracy compared to existing practice of using paper based diaries and assessments. eCOA provides less variable and more reliable data enabling smaller trials and better scientific conclusions. 
 
ERT’s eCOA solutions include both products and services for clinical trials. ERT manufactures devices which include handheld electronic diaries, tablets, spirometers that are designed exclusively for clinical research and enable high resolution, remote collection, memory and automatic data transmission. ERT also provides an Interactive Voice Response (IVR) system accessible through standard telephone lines and offer device customization, worldwide logistics and our in-house global and local support to ensure comprehensive and efficient trial management. ERT’s sells expertise in COA Strategy, Instrument Selection / Modification / Development, Instrument Migration from Paper to Electronic Format, and Regulatory Support.