Careers

Spaulding Electrocardiograph Workflow

The Spaulding Electrocardiograph was designed to enable acquisition of diagnostic 12-lead ECG's anywhere the test may be required and cost-effectively centralize cardiac safety information for cardiology over-read and reporting.  The workflow has been streamlined to remove any unnecessary steps and is programmed based on the study protocol resulting in high quality study results while minimizing queries.

Data is uploaded immediately to the Spaulding webECG Management Cloud, where Cardiologist, Investigators and the Study Team can view the data.  An optional real-time interface is available to Medidata Rave that includes the 12-lead ECG Measurements and Cardiologist interpretation with waveforms

See how easy acquiring a 12-lead is with the Spaulding Electrocardiograph:

 

Sponsor Feedback

Hear what our Sponsor's have to say about our services:

 

"Congratulations!!!  You make my day every day because you and your company provide flawlessly."

 

"Excellent hands on approach to get sites trained and started for two large Phase III studies that were already in progress!"

 

"Spaulding Clinical has the responsiveness and flexibility that some of the larger Core ECG Labs do not have.  It was a pleasure working with the Spaulding team."

 

"The web portal is awesome!"

The Spaulding Cardiac Advantage

Cardiac Safety Expertise

  • ECG Analysis and Expert Reports by world-renowned Cardiologist
    • Dr. Jay W. Mason, CMO, is a world-renowned cardiac drug safety expert with 35+ years of experience as well as former director for a major cardiac core laboratory
  • All readers are Cardiologists with current medical licensure
  • Product Managers with over 10 years of Cardiac Safety experience managed by senior director with extensive industry experience
    • Chéri Barta, Sr. Director with over 18 years of experience at 2 major cardiac core laboratoriesSpaulding Cardiac Safety Diagram
  • Global network of local country partners provides logistical support

Cloud-based Technology

  • Proprietary Spaulding Electrocardiograph provides up to 5 minutes of ECG data
  • Cloud-based Spaulding webECG™ cost-effectively centralizes all ECG study data
  • Real-time interface to Medidata Rave including 12-lead ECG measurements and Cardiologist interpretation with waveforms
  • BioQT™ automated analysis platform

Protocol-Driven Process

  • Study-specific operational plan drives excellence
  • On-demand client and study specific data exports
  • Client Services Representatives available 24-hours/365 days a year
  • Standardized processes drive consistent study execution every time
  • High customer and investigator satisfaction

 

Capabilities

Cardiologist Consultation and Expert Readers

  • Expertise in cardiac safety methodology, analysis and regulatory reporting
  • Consulted with well over 100 clients on study design
  • Pre-study representation provided for regulatory review
  • Board-certified or country equivalent Cardiologist, trained for pharmaceutical reading
  • Internet-based Cardiologist interpretation tools are 21 CFR Part 11 compliant
  • Readers are available to cover all time zones with 24, 48 or 72 hour turnaround times

Project Management

  • Development of Operational Plan based on the Sponsor's protocol to manage workflow and provide overall excellence
  • Proactive customer support for rapid issue resolution
  • Global equipment logistics partners to facilitate equipment shipping and supplies
  • Global experience from Phase I through post-market surveillance

Proprietary Spaulding 12-lead ECG Solution

  • Designed for clinical research, the Spaulding Electrocardiograph is:
    • Small to decrease shipment cost
    • Easy-to-use with single button, protocol-driven user interface
    • Powerful with the ability to store 5 minutes of ECG data
  • Mason Protocol directs workflow based on the study protocol reducing queries
  • Spaulding webECG™ Management Solution, provides cloud-based centralization of data
    • Credentialed access for sponsors and investigators
    • Numerous reported options including Summary or Selected 12-lead Report, Arrhythmia Reports, Spaulding 12-lead ECG Report
  • We also offer the full suite of Mortara ECG and Holter equipment

Data Management

  • Database design
  • Data transfers to Sponsor monthly or as specified
  • On-demand data export in client required format
  • Data transfer to the FDA ECG Warehouse
  • Optional data interface of real-time data to client's Medidata Rave cloud
  • Expert reporting and analysis
  • Data archiving

Global Study Capability

  • Currently conducting clinical studies on 5 continents
  • Customer support offered in local languages through interpreter service
  • Network of local partners deliver local logistical support to investigators if needed

TQT Clinical Conduct and Seamless Data Transfers

  • Fully integrated service offering with Clinical Pharmacology, Biometrics and Cardiac Solutions for TQT Studies or development of early cardiac safety profiles
  • Data is directly interfaced to our Cardiac Solutions experts saving significant time
  • Data transfer to FDA ECG Warehouse
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