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Published by, 2018-12-21 11:20:21

HeartcoR Solutions Overview

HeartcoR Solutions Overview

Cardiovascular Core Lab

Business Overview


Larry Lawson
Harold Strandquist
Madalina Andreescu
Jerry Wiseman
Mark Mentzer
About Us
Founder President Vice President,
Manager, Clinical Director,
Business HeartcoR Solutions
Operations Business HeartcoR Solutions is a Cardiovascular Core Lab, focused on the
acquisition and analysis of ECG data within clinical trials.
Development Located in greater Chicago, we work with 4 of the 5 largest
Cardiovascular Medical Device companies in the world, and are
expanding our platform to include eSource driven 12-lead resting ECG
to support Cardiac Safety and Efficacy endpoints within pharmaceutical


Technology Specialists

HeartcoR Solutions is Founded and Managed by
Industry Experts

▪ Management team has been building and leading innovative diagnostic ECG
equipment, systems and service businesses since the ‘90s

▪ Leveraging experience to utilize the most modern commercial technologies
available for more dependable, lower cost business model

▪ Scalable and adaptable AWS infrastructure with eSource platform for collecting,
analyzing and reporting of electronic ECG data

▪ Wireless, body worn devices and Tablet/Laptop based ECG provide sites and
patients with tools ideally suited for clinical trials


Your Ideal Partner Platform

Smart and Simple Solutions eSource


Wireless Event, Body Worn or Tablet/Laptop Based


Industry standard tools integrated directly into eSource


Customized dashboards per role, with drill down capabilities based
on access



ClinSpark eSource System Running in AWS

▪ eSource is designed to receive multiple electronic source data inputs, and
provides single workflow regardless of acquisition equipment

▪ eSource also allows bi-directional communication with devices from central or
enrollment database, no demographic entry at device

▪ Secure distributed access to data, transparency for site and sponsor

▪ Customized dashboards provide site and sponsor with up to the minute metrics.
Queries are managed directly in the system, with all looking at same data

▪ AWS provides greatest security and performance available, never tied to
inefficient legacy systems and capital investments



Event and Continuous Holter Monitoring

▪ Combination of event, patch and Holter modes in single device
▪ Provides remote symptomatic event reporting when patient needs it
▪ Allows for continuous Holter recordings that can be transmitted directly from

patient’s phone, no follow up visits needed for data transmission
▪ Ensures data is automatically transmitted to lab, eliminates data loss in shipping
▪ Ideal for studies requiring multiple patient or site initiated recordings
▪ Traditional 3-lead and 12-lead Mortara Holter recorders available as well



12-Lead Resting ECG connected to eSource

▪ Industry-standard Mortara Instrument PC Based ECG system fully
integrated with ClinSpark eSource system

▪ User experience is significantly enhanced through large screen and
enhanced workflow

▪ Demographics populated through ClinSpark interface, no data entry
required; No data entry errors

▪ Real-time ECG on screen, site is sure of quality ECG acquisition
▪ Optional computerized selection of best ECG segment, based on

algorithmic analysis of signal quality



Precision, Compliance, Access, Integrated into

▪ Industry-standard AMPS CalECG digital ECG Analysis tools fully
integrated within the ClinSpark eSource system

▪ Integration means data never moves from central database, no data
loss or errors in transferring from one system to another

▪ HeartcoR Cardiologists log into system and perform over-read of
ECGs from wherever they are, improving turn around times

▪ Results from Cardiologist reads can be immediately available to Site
and Sponsor upon completion and signature

▪ Measurement and Annotation of electronic ECGs in 21 CFR part 11
compliant environment



Insight and Transparency

▪ The single, secure, cloud-based database means uninterrupted access to data

▪ Reporting on subjects, clinical findings, site metrics and queries can be
customized to individual client preference on both the site and study level

▪ Sites can view worklists, ECG results, completed ECGs, alerts, and work through
any site queries directly within ClinSpark, without the need for phone calls and

▪ Sites can view ECGs that have been transmitted from their tablets to ClinSpark as
soon as they are sent, and can review Cardiologist over-read of their ECGs any
time (with permissions)

▪ An active Sponsor can know with certainty the state of their ECG study from
wherever they are, at any moment in time without needing to ask



Your Ideal Partner

▪ HeartcoR has established itself as a partner with 4 of the 5 largest
Cardiovascular Medical Device Companies in the world

▪ HeatcoR’s team understands the challenges sites face in collecting data
▪ HeartcoR utilizes the most modern technology assist sites in collecting

error free, high quality ECG data from multiple sources
▪ Sponsors and sites enjoy the access to data that a centralized eSource

platform provides
▪ HeartcoR Solutions is your ideal partner for Cardiovascular Core Lab

solutions that make sense

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