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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