Spaulding Clinical Cardiac Safety Solutions
Cardiac safety concerns remain the number one cause for market drug withdrawal. Regulatory submissions for new drugs must demonstrate that the proper cardiac safety assessment has been conducted.
When Your Study Requires Cardiac Safety Monitoring, Think Spaulding First.
Spaulding Cardiac Advantage
- With Spaulding Cardiac Solutions, you benefit from an industry-leading team of experts, including world-renowned cardiologists, that works closely with you to identify cardiac risk early in the drug development process.
- We proactively advise you, building a robust cardiac safety profile that allows you and regulators alike to make confident decisions related to your compound.
- Using our proprietary technology platform and processes, we execute your studies flawlessly, starting with your single ascending/multiple ascending dose studies.
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 that are 21 CFR Part 11 compliant
- Readers are available to cover all time zones with 24-, 48-, or 72-hour turnaround times
- 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 Electrocardiograph (ECG) Solution
- Designed for clinical research, the Spaulding ECG is:
- Small, decreasing shipment cost
- Easy-to-use, with single-button, protocol-driven user interface
- Powerful, with the ability to store five 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
- 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 five 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
Choose Spaulding Cardiac Solutions for your next study and get high quality ECG data — in less time and at a lower cost.