ABPM SERVICES

Consulting

Cardiocore’s scientific experts assist sponsors in the development of advanced and effective strategies for ambulatory blood pressure monitoring (ABPM), as well as clinic blood pressure monitoring (CBPM) and home blood pressure monitoring (HBPM). Pre-study consulting services include strategic planning, protocol review, protocol development, and regulatory assistance. These services are available for both safety and efficacy testing in Phase

I–IV studies.

Project Management

Cardiocore implements projects in three distinct phases: Planning, Execution and Control, and Closing. The company’s Project Management Standard Operating

Procedures (SOPs) are built on the principal that successful execution of the Planning phase is the most effective way to ensure flawless performance in the Control and Closing phases. Every Cardiocore project is governed by a detailed Project Charter, developed through sponsor collaboration. Projects begin with formal kick-off meetings, procedures are tracked daily, reports are published weekly, and metrics are measured continuously. Final checklists and formal closeout meetings ensure that projects end on time, and are supported by comprehensive documentation.

BP Monitoring Equipment

Cardiocore provides leading-edge BP monitoring devices for clinical trials. Equipment models include the Tiba Medical Ambulo 2400 for ABPM, the BpTRU BPM-200 for CBPM and various HBPM solutions, depending on protocol requirements. These devices represent state-of-the-art technology in their respective classes. For example, the Ambulo 2400 offers many advantages over other ABPM equipment, with its industry-leading accuracy ratings and unique built-in actigraphy data capability.

Customer Support

Cardiocore’s customer support staff pre-configure BP monitoring devices and data upload stations to enable easy site set-up and digital transfer of BP data to Cardiocore’s protocol-specific database. Quality control testers examine each device prior to shipping, and equipment deliveries include multiple sizes of cuffs, waist clips, shoulder straps, Quickguides, and other supplies necessary to support a study’s BP acquisition requirements. Cardiocore employs major shipping and expediting services for international deliveries and has experience in more than 60 countries, on 6 continents, across 21 time zones. Customer Support services are available and every site in every country receives a toll-free Customer Support phone number. In addition, real-time translation services are available in 157 local languages.

Site Training

Cardiocore delivers equipment to each site prior to training and assists site staff in completing successful test procedures prior to transmitting actual study data. Training sessions are provided in three formats: in-person at Investigators Meetings, in-person at study sites, and via the Internet with live trainers. Cardiocore’s training sessions cover the use of equipment and protocol-related processes. Comprehensive Investigator Reference Manuals encompassing all services, and equipment for studies are supplied for use by site personnel. Cardiocore’s training sessions are designed to ensure site staff:

• Understand the functioning of all equipment and BP data upload software
• Understand how to administer BP monitors and their accessories, including cuffs
• Understand how to acquire and transmit BP data
• Understand the protocol’s BP requirements and time-point schedule
• Have all required contact information for Cardiocore’s protocol-specific team
• Have received the comprehensive Investigator Reference Manual, encompassing all services and equipment

BP Analysis

To ensure continuous collection of top-quality data, Cardiocore maintains a highly experienced team of cardiac medical doctors and cardiologists for review and monitoring of BP procedures. Our easy-to-use BP data upload system offers instant feedback to site personnel, even before the data is transferred to Cardiocore. This immediate information enables site staff to make key decisions or perform additional procedures if needed. Once centralized, the data is processed into analyzable sets, including requested systolic BP, diastolic BP, heart rate, mean arterial pressure, pulse pressure and rate pressure. Our system also provides uniquely valuable actigraphy data that enable accurate categorization of sleep/wake cycles for enhanced BP analysis.

Expert Reporting

Cardiocore’s team of senior scientists and statisticians provide comprehensive Statistical Analysis and Scientific Reports. Along with comprehensive tables, figures, and graphs, these documents include statistical and analytical methods, BP methodologies, study design details, stratification, end-point information, and scientific conclusions.