The MDS Pharma Services Advantage

• One provider meets all of your needs
• Global, integrated SOPs in a single operation obviates the need for site training
• Internal WAN State-of-the-art infrastructure:
• Improves data quality
• Shorter turnaround times
• Operating efficiencies save time and money

MDS Pharma Services produces highest-quality ECG data

The implementation of the ICH E14 guidance has transformed cardiac monitoring in clinical trials. The “Thorough QT/QTc” or Definitive QT trial has become a critical component of EMEA and FDA submissions, creating increased focus on cardiac monitoring and ECG quality throughout drug development. If your next trial requires extensive cardiac monitoring, you should know that MDS Pharma Services offers the expertise to guide you from development through submission. And you can feel confident in your trial results because of our well-established history of producing high-quality ECG data.

Unparalleled Experience

• More than 100 ECG-intense Phase I trials
• Crossover and parallel studies, 28 to 250 subjects
• Global SOPs ensure consistent data across sites
• 24 and 48-hour 12 lead Holter experience
• Familiarity with multiple 12 Lead ECG platforms
• Phase I sites have experience with multiple cardiac service providers
• Dedicated ECG Project and Program Management staff
• Centralized Cardiac Services has experience with multiple phase I CROs
• Hand-in-glove relationship with MDS  Pharma Services Centralized Cardiac Services
•  Highest quality data
• Turn-Key operation
• Operational efficiencies result in cost savings

Highest Quality Data

• Never missed a Moxi signal
• Industry leading reader certification and on-going variability assessment program
• Within subject variation of 6 ms for crossover design*
• Within subject variation of 12 ms for parallel**
• Focused ECG technician training emphasizes unique requirements for QT assessment
• Equipment and technology selection led to a 99.5% ECG readability metric

Large Phase 1 Capacity

• Over 1000 beds avaliable globally
• Allows greater scheduling flexibility
• Excellent participant enrollment and retention
• 96% On-time starts

Scientific Expertise

• Strategic cardiac safety consultation
• Study design
• Expert reports
• Medical Advisory Board approves all technical training

Full-service

• Protocol development
• Data Management
• Fully Integrated Statistical Analysis
• Study Reports
• Regulatory submission
• ECG warehouse upload