Cardiac Safety & Efficacy in Clinical Trials
Biomedical Systems is a global leader in the centralization of cardiac safety and efficacy diagnostic data for pharmaceutical and medical device clinical trials. Biomedical Systems is the only company in the world to offer a full complement of cardiac modalities including:
Digital 12-Lead ECG | TQT/Intensive Studies | Holter Monitoring | Cardiac Event Monitoring | Ambulatory Blood Pressure Monitoring | ECG Stress Testing | Impedance Cardiography | Echocardiography | Wireless ECG Monitoring
Centralizing Data for Clinical Trials
Biomedical Systems participated in our first centralized ECG clinical trial over 25 years ago. Since that time, we have managed more than 8,000 cardiac safety trials across the globe. Along the way, Biomedical Systems has progressively incorporated diagnostic testing services for cardiac safety and efficacy trials to meet our clients’ regulatory and discovery needs. The resulting complement of modalities offers Biomedical Systems’ clients the ability to contract with a single vendor for multiple modalities. Additionally, Biomedical Systems offers a variety of equipment options and possesses a store of over 15,000 ECG machines allowing us to be efficient and flexible in meeting our sponsors’ requests.
Biomedical Systems’ Proven Methodology
Biomedical Systems’ proven methodology centers upon minimizing variability by dedicating a cardiologist over-reader and standardized equipment and processes.
- International, board certified, sub-specialty medical experts in cardiology
- Reduces variability associated with the reading of measurements and interpretations of the diagnostic data
- Wide range of equipment options to fit specific needs of protocol
- Same make and model equipment distributed to all clinical study sites
- Increases consistency and efficiency in training
- Reduces data discrepancy
- Standard Operating Procedures (SOPs) for North American and European receiving centers
- Ensures data collected internationally processed identically
- Supports protocol requirements
TruVue Wireless ECG Monitoring
TruVue Wireless Ambulatory ECG Monitoring is the only ECG monitor that collects ALL of the ECG in a given period of time...
TruVue Wireless ECG Monitoring in Clinical Trials
In 2010, Biomedical Systems introduced the TruVue® Wireless Ambulatory ECG Monitoring System for the diagnosis and management of complex cardiac arrhythmia. TruVue offers the advantages of both a Holter and Cardiac Event monitor in one device. The patented technology employs cellular communication to transmit recordings of every heartbeat to Biomedical Systems' secure servers. The system's algorithms analyze the incoming data for changes in morphology, rate or rhythm, in addition to patient-triggered alerts when symptoms are experienced. Certified cardiac technicians validate the findings, post reports in real-time and alert physicians based on cardiac events or notification criteria. At any time, physicians can access information online, including any portion of the recorded ECG monitoring and trend reports detailing 24-hour heart-rate and rhythm abnormalities, including atrial fibrillation.
Currently, pharmaceutical and medical device companies are employing TruVue to assess the cardiovascular safety and efficacy associated with new drugs and devices. In pharmaceutical clinical trials, TruVue's heart monitoring capabilities support the efficient and accurate capture of valid data during Phase 1 to IV clinical studies or in post-marketing surveys. When employed in clinical trials, TruVue is supported by around-the-clock patient support and services provided by professional, courteous Biomedical Systems staff. TruVue has received both its 510(k) clearance from the U.S. Food and Drug Administration and its CE Mark for international sales. Biomedical Systems' Cardiology Division has employed TruVue since 2010, conducting thousands of ECG wireless telemetry procedures.
- Advanced arrhythmia analysis which processes the incoming ECG twice for each 24 hours received Algorithm triggers:
Atrial Fibrillation Ventricular Fibrillation Idioventricular Rhythms Pause/Asystole Supraventricular Tachycardia Tachycardia Ventricular Tachycardia Bradycardia
- Algorithm findings validated by certified cardiac technicians
- Results immediately posted on-line or faxed for Physician review, measurement, and interpretation
- On-line access for Physicians/Staff to full disclosure ECG from any day of monitoring
- Customizable reports including significant event, daily/weekly monitoring, AF burden, and summary
- Records/transmits every heartbeat for up to 30 days improving ability to diagnose intermittent symptoms
- Records 2 channels of ECG
- ECG analysis performed on powerful computer servers rather than on an embedded microprocessor
- Comprehensive, long-term monitoring solution for patients with existing cardiac arrhythmias
- Patient-friendly, handheld communication device specifically designed for ECG monitoring
- Automatic wireless data transmission
- Secure servers for arrhythmia analysis, technician review/validation, and ECG storage
- Provides immediate on-line access to all transmitted ECG
- Reports and findings may be reviewed from any Windows computer with Web access
The standard 12-lead electrocardiogram (ECG) is the most common and least intrusive test for cardiac safety and efficacy trials...
12-Lead ECG Monitoring in Clinical Trials
International regulatory agencies have identified cardiac safety as a significant issue in clinical trial research; thereby, increasing the number of protocols with a cardiac safety component. The standard 12-lead electrocardiogram (ECG) is the most common and least intrusive test for cardiac safety and efficacy trials. As such, centralization of digital ECGs has become the standard in the clinical trial arena improving efficiency, accuracy, and most importantly, the quality of data.
Over the last several years, the ECG core lab industry has seen a great deal of consolidation resulting from bankruptcies, buy-outs, or companies simply closing. For over 25 years, Biomedical Systems has been supporting our clients’ digital ECG clinical trial needs providing centralized ECG services in over 2,500 studies. We continue to maintain our position as a global leader in centralized diagnostics testing by investing in the things that are most important to sponsors; well trained people, state-of-the-art equipment and systems, and the infrastructure to support international studies.
Clients utilizing Biomedical Systems’ centralized ECG services enjoy real time access to clinical trial data via Biomedical Systems’ proprietary BMS Gateway ECG management system. BMS gateway provides secure, instant access based on user rights to essential study information including ECGs, PDFs of site printouts, alerts, metrics, shipping, and financials. Data can be downloaded onto an excel spreadsheet and sorted to produce reports that meet clients’ immediate needs.
Digital 12-Lead ECG Clinical Trial BenefitsExpert Analysis
- Single cardiologist over-reader assigned per study, with the exception of accelerated TQT studies
- Complete Inter/Intra reader variability program
- 21 CFR Part 11 electronic documents and electronic audit trail compliance
- Complete 10-second electronic digital raw ECG waveforms with electronic storage
- Electronically captured cardiologist’s annotations, all ECG interval onsets and offsets
- BMS Gateway web-based access to data and reports
- 24/7/365 customer service and technical support
- Protocol specific metrics available
- Data verified and cleaned before electronic submission
Thorough QT/Intensive Studies
TQT/Intensive studies use precise methodologies to detect and evaluate the QT interval prolongation of small magnitudes to better...
Thorough QT Studies/Intensive Studies in Clinical Trials
Addressing Cardiac Safety Concerns for Drug Induced Prolonged QT
The FDA primarily calls for the withdrawal of a drug from the market, limits a drug’s indications, or denies pharmaceutical companies approval to market a drug due to cardiac safety concerns. A major issue of concern is drug induced delay in cardiac repolarization. As a result of such concerns, the FDA with international regulatory organizations has requested pharmaceutical companies and biotech companies conduct more intensive testing for cardiac safety concerns utilizing protocol designs known as Thorough QT studies or Intensive QT studies.
Thorough QT/Intensive QT Studies Protocol Design
In 2005, the FDA released guidance for the clinical trial industry in E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The E14 document indicates a need for additional cardiac safety testing when a positive signal for QT prolongation is found in pre-clinical development of a compound. Thorough QT/Intensive QT studies use precise methodologies to detect and evaluate the QT interval prolongation of small magnitudes to better assure a new drug’s cardiac safety.
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs recommendations:
- Conduct trial early in drug’s development process, not as first-in man study
- Recruit healthy volunteers
- Establish assay sensitivity using positive control
- Acquire ECGs with:
- Triplicate measurements
- Time matched time points
- Time points around the Cmax
FDA Warehouse and ECG Submissions
Based on recommendations from The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs concept paper released for discussion by the FDA in 2003, annotated ECG waveform data for studies that definitively address the effects of a drug on ventricular repolarization is critical. As such, the FDA entered into a Cooperative Research and Development Agreement with Mortara Instruments to design a repository to house and manage the massive number of ECGs that would be required for these trials. A standardized reporting format was needed to ensure that the data was consistent between sponsors and trials which led to the adoption of the HL7 and XML formats, the language for all ECGs transmitted to the warehouse. As a leader in the cardiac safety and efficacy clinical trial industry, Biomedical Systems has been submitting data to the FDA ECG Warehouse on behalf of sponsors since 2004 and has continued to submit data to the warehouse regularly ever since its public rollout in 2005.×
Founded as a Holter service provider in 1975, Biomedical Systems has been minimizing variables to allow the data acquisition process to...
Holter Monitoring in Clinical Trials
Introduced in the late 1960s, Holter monitoring became the first ambulatory ECG test available and is still considered the gold standard in ambulatory ECG. Holter monitoring devices offer a more comprehensive picture of cardiac activity, recording every beat for up to 7 days on 3 – 12 leads, or channels. A digital 12-lead holter allows clients to acquire up to 48 hours of continuous 12-lead ECG data with the option to analyze all the data available or pick and choose protocol specific ECG time points. By comparison, the standard 3 lead holter device can be worn for up to 7 days. Regardless of the device chosen, holter analysis software quantifies all abnormalities. Data is transmitted electronically via the Data Exchange Program or sent by courier to one of Biomedical Systems’ facilities in North America or Europe where a cardiac technician validates the findings.
Founded as a Holter service provider in 1975, Biomedical Systems has been minimizing variables to allow the data acquisition process to be efficient, cost-effective, and accurate for over 35 years. In that time, Biomedical Systems has acquired and analyzed over 2 million holter recordings as well as engineered and developed holter analysis systems including the Century C3000 and BMS 300. Our approach to the centralization of Holter monitoring includes standardizing equipment, accessories, and disposable supplies. Biomedical Systems provides our clients with round the clock customer service and technical support from any one of our four international locations.
Holter Monitoring Clinical Trial BenefitsExpert Analysis
- Qualified cardiac services technicians review readings
- Various site training options
- Reports include summary of counts, hourly quantification of all ECG rhythms, heart rate variability, histograms and trends, sample strips, and full disclosure.
- Standardized equipment and software
- Little patient compliance necessary
- Improved diagnosis with multiple leads
- 3 to 12 Leads available for analysis
- Extraction of discrete 12-Lead ECGs
- Protocol specific training manuals and quick guides
- Site test data transmitted for validation and certification
- 24/7 service and technical support
Cardiac Event Monitoring
Many Sponsors use Holter Monitoring to capture every heartbeat over a 24 or 48 hour time period for a more comprehensive picture...
Cardiac Event Monitoring in Clinical Trials
Introduced in the late 1980s, Cardiac Event Monitoring (CEM), also known as Transtelephonic Arrhythmia Monitoring (TTM) involves patient utilization of a cardiac monitor which typically records a single channel of ECG using two electrodes for up to 30 days. The ECG recording is intermittent, taken in 1 to 5 minute samples. Recorded ECG data is transmitted via telephone to a receiving center where rhythm strips are reviewed by certified cardiac technicians. Cardiac Event Monitoring requires 24/7 receiving of ECG transmissions and provides no quantification of abnormalities; however, CEM does provide a longer monitoring period improving the ability to diagnose intermittent symptoms in patients and rule-in or rule-out arrhythmia as the cause of patient symptoms.
For 25 years, Biomedical Systems has provided protocol development, standardized equipment, study and data management, and technical support services for cardiac event monitoring used in clinical trials. We continue to meet our clients’ needs by offering a variety of equipment options including non-looping, looping, and looping with auto-trigger devices. In order to make equipment recommendations that ensure the appropriate data outcomes per protocol requirements, Biomedical Systems provides our clients with consultation services. Regardless of the equipment chosen, all of our clients enjoy friendly, professional customer service from fully certified cardiac technicians as well as technical support 24 hours a day, 7 days a week, and 365 days a year from any one of our four strategically located international offices.
Cardiac Event Monitoring Clinical Trial BenefitsExpert Analysis
- Cardiac technician reviews rhythm strips
- Reports include patient transmission reports, summary report at monitoring period end
- Board certified cardiologist interpretation of reports available
- Convenient for patients with only 2 electrodes
- Several equipment options with CE marks
- Specifically designed for recording patient symptoms
- Non-looping and looping equipment options
- Simple auto-triggers on some devices:
- Atrial Fibrillation
- Patient transmission via telephone
- Requires 24/7 receiving of ECG transmissions
Echocardiography is utilized as a non-invasive, cost-effective modality to examine the anatomy, structure, and function...
Echocardiography in Clinical Trials
Echocardiography is utilized as a non-invasive, cost-effective modality to examine the anatomy, structure, and function of the heart in clinical trials. Data is acquired and measured according to the American Society of Echocardiography (ASE) guidelines and analysis includes but is not limited to complete cardiac chamber dimension, cardiac wall thickness, left ventricular mass, segmental wall motion analysis, cardiac valvular structure, function and competency, cardiac chamber pressures and filling capacities, contrast echocardiography including perfusion studies, and diastology. Due to the technical and sophisticated nature of the test, it is extremely important to work with a service provider that has echocardiography expertise.
Since 1989, Biomedical Systems has offered centralized echocardiography services in such therapeutic areas such as coronary artery disease, Duchenne muscular dystrophy, HIV, migraine, myocardial infarction, oncology, pediatric pulmonary arterial hypertension, and Pompe disease among many others. Biomedical Systems’ echocardiography team is skilled in 2D, M-Mode, contrast agents, and Doppler techniques and participated in the largest FDA mandated echocardiography clinical trial. Our experts provide a comprehensive training and site qualification process as Biomedical Systems recognizes the importance of standardization in clinical trials.
Biomedical Systems provides independent core lab cardiologists to assist or completely design protocols which meet clients’ and FDA requirements. Biomedical Systems’ expert cardiologists are internationally recognized educators, speakers, and authors including, among other industry awards and accolades, past presidents and honorary fellows of ASE, best doctor award recipients, and America’s Top Cardiologists as designated by Consumers’ Research Council of America. Our cardiologists provide 24/7 interpretations of echocardiograms utilizing Digisonics DigiView Reading and Reporting Station and abide by guidelines that follow ASE/EAE recommendations for clinical trials. DigiView is DICOM and 21 CFR Part 11 compliant providing full security, audit trail, and electronic signature capabilities.
Echocardiography Clinical Trial BenefitsExpert Analysis/Training
- Protocol specific guidance with expert cardiologist
- Cardiologist and Registered Diagnostic Cardiac Sonographer dedicated to study
- Site training and certification for submission of quality echocardiograms
- Quality of echocardiograms continuously monitored by Registered Diagnostic Cardiac Sonographer
- Analysis performed on validated 21CFR Part 11 compliant system
- Secure remote access reading system available
- Top-rated clinical image management and structured reporting
- Ability to receive electronically transmitted images from the site for processing
- 24/7 service and technical support provided by I.T. or Registered Diagnostic Cardiac Sonographer
Ambulatory Blood Pressure Monitoring
Ambulatory blood pressure monitoring (ABPM) offers clients a method to automatically acquire multiple, indirect blood...
Ambulatory Blood Pressure Monitoring in Clinical Trials
Many compounds can cause blood pressure parameters to change, increasing a drug’s cardiac risk profile. Ambulatory blood pressure monitoring (ABPM) offers clients a method to automatically acquire multiple, indirect blood pressure readings and measurements for an extended period of time with minimal intrusion into the daily activities of patients. In clinical trials, measurements acquired can be correlated to dosing times, resting periods, and other prescribed time points which may affect a patient’s blood pressure to clarify a drug’s safety or efficacy.
Biomedical Systems has been centralizing ambulatory blood pressure data for international, multi-center clinical trials since 1987. Centralizing ABPM services with Biomedical Systems provides our clients with standardized equipment, all necessary consumable supplies, and properly captured data via our site certification process and protocol specific site training manuals. Our proven approach combines an experienced, service-oriented project management team with established non-invasive monitoring technology to ensure studies are completed efficiently and in a cost-effective manner. Biomedical Systems’ equipment and services are backed by global customer service and technical support offered 24 hours a day, 7 days a week, 365 days a year from our North American, European, and Asian offices.
Ambulatory Blood Pressure Clinical Trial BenefitsExpert Analysis
- Qualified cardiac services technician reviews readings
- Standardized ABPM devices and laptops throughout sites
- Immediate results available on laptop
- Transmission via toll free number or internet connection
- Web-based access to data and reports
- Protocol specific metrics available to sponsors
ECG Stress Testing
The value of ECG stress testing (ETT) in clinical trials lies in its ability to detect and assess the degree of coronary disease...
ECG Stress Testing in Clinical Trials
The value of ECG stress testing (ETT) in clinical trials lies in its ability to detect and assess the degree of coronary disease indentifying possible cardiovascular risk and evaluating treatment response. Patients with coronary artery blockage may produce normal ECGs at rest; however, when the heart is exposed to exercise, significant disease symptoms such as chest discomfort or shortness of breath can be revealed as characteristic abnormalities on the ECG recording. The ECG complex most representative of coronary artery disease is ST segment depression, an indicator of low blood flow to the heart muscle.
Since 1998, Biomedical Systems has participated in ECG stress testing for clinical trials. Our proprietary Biomedical ECG Acquisition Management System (BEAMS) allows clinical sites to easily hook-up several different models of treadmills and exercise bikes to acquire and analyze the ETT in progress. Pre-programmed exercise protocols including Bruce, Balke, and sponsor specific programs assure site compliance to protocol requirements. Prompts for blood pressure checks and post-test summary reports help to ensure sites perform all required procedures during the patient’s visit. In addition to the advantage that Biomedical Systems’ centralized approach offers, our clients also receive unparalleled customer service and technical support from any of our four centrally located global offices 24 hours a day, 7 days a week, 365 days a year.
ECG Stress Testing Clinical Trial BenefitsExpert Analysis
- Qualified cardiac services technician reviews findings
- Various site training options
- Standardized laptop and software
- Software compatible with over 15 treadmills
- Pre-programmed exercise protocols available
- Anti-left lock
- Site test data transmitted for validation and certification
- 24/7 service and technical support