A Global ECG Core Lab
and Medical Device Safety Studies
HeartcoR Solutions provides expert ECG recording, certified technician analysis, electrophysiologist overreading and validated data set delivery to support our customers’ global regulatory filings. Our best-in-class clinical operations team provides the latest ECG recording and telemetry devices to collect, analyze, and deliver your cardiac safety studies.
MEET THE TEAM
Get to know: Cayla Kleeman, Clinical research associate for HeartcoR Solutions.
MEET WITH HEARTCOR
DPHARM September 21-22 2023 in Boston, MA.
LEARN HOW WE CAN HELP
Download our one-page sell sheet to learn more about HeartcoR’s cutting-edge technology, experienced personnel, and
high-touch customer service.
Who we work with
Pharmaceutical companies in early or pivotal study phases preparing IND filings and conducting post-market surveillance
Medical Device companies, large and early stage, preparing PMA submissions, as well as post-market surveillance studies
Contract Research Organizations (CROs) whose pharmaceutical or medical device sponsors need expert evidence of cardiac rhythm safety for their client company’s regulatory filings and ongoing support studies
Leading healthcare companies choose HeartcoR
HeartcoR is the top choice for four of the largest global healthcare companies as well as startups seeking initial market approval because we deliver:
- High-touch customer service leading to high patient adherence.
- On-time, on-budget project delivery.
- Cutting-edge data capture devices and ECG analysis software technology solutions.
- Protocol-specific and customized data reporting for study progress tracking.
- A deep bench of ECG-certified technicians, QA oversight, and board-certified electrophysiologists to conduct tracing analysis.
“Amidst the busyness on both sides, it is very important to recognize what is working well as we continue to work on fixing the other ongoing issues.
I wanted to take a moment to thank your team’s efforts in trying to get our company’s data review back on track. Special kudos to Destinee who seems to have offered excellent customer service to one of our participating sites.”
“Through the years I have been part of many studies and have been reintroduced to my HeartcoR contact who greeted me with the kindest, most welcome feeling. He’s never flustered or bothered by my many emails and requests. I am not sure what official position he holds within your company, but I know he exhibits the intelligence, kindness, and thoroughness of a true leader.”
“Thank you HeartcoR team for
giving great service to our sites!”
What sets HeartcoR apart
Cardiac Arrhythmia data collection occurs anywhere our customers need
Customer focused, protocol trained study teams are dedicated to each sponsor project.
Standard and ad hoc study reporting to meet specific sponsor project requests.
Sponsor program studies are staffed, trained, and retained over ongoing projects to promote continuity of operational requirements.
Global reach: Remote ECG acquisition is accomplished by HeartcoR at global study sites, patient homes, or other decentralized healthcare settings.
Advanced data recording devices: HeartcoR sources and deploys the latest ECG recording devices for each of the clinically required modes of safety recording.
HeartcoR continues to add the latest approved/validated analysis software to deliver clean data, faster while maximizing patient adherence.
Each HeartcoR customer’s clinical study protocol differs in design. To meet our customer’s requirements, we collect ECG data in four modes within study-specified time periods. ECG collection modes are defined by the time required for capture and reporting of a cardiac rhythm segment. Click the arrows to learn about these modes.
Usually 60-second recordings that monitor the effect of a treatment, post therapy. Our event collections are accomplished with an easy-to-use handheld device actuated by an application situated on a locked cell phone provided by HeartcoR.
Longer than event recordings, Holter recordings are typically 24 hour, continuous cardiac rhythm collections for assessing cardiac reactions to a therapy over a longer timeframe. HeartcoR Holter recordings are collected by a small, hydrogel patch electrode easily positioned on the patient’s chest. The patch electrode is actuated by a separate application on the locked cell phone provided by HeartcoR to study participants.
Mobile Cardiac Telemetry (MCT) is a real-time ECG collection mode technology that may be prescribed in a clinical study. HeartcoR special orders MCT collection devices, if requested by a client for its study protocol.
12-lead ECGs use 10 electrodes to produce 12 different views of the heart’s electrical activity. 12-lead ECGs are typically collected from a patient at rest as a snapshot of electrical heart activity. HeartcoR uses the latest 12-lead system for data collection when such studies are required by a clinical protocol.
HeartcoR is constantly evaluating new recording devices to simplify the patient experience and
ECG collection efforts by site staff, and to improve patient adherence and data reporting.