Cardiac Safety Services
Solutions you need to achieve your goals in cardiac safety in drug development
The proper assessment and reporting of cardiac safety data is a key component of your compound’s journey through clinical trials. Issues of cardiovascular safety with a new compound are seldom limited to a single study or phase. Bioclinica supports your entire study cycle, from Phase I to Phase IV. We offer a range of services to help you effectively plan, implement, and report on the cardiovascular safety of your drug.
Key components of cardiac safety in clinical trials
Bioclinica’s cardiovascular safety team has a deep understanding of the key endpoints needed for successful cardiac safety studies, including ECG measurement, QT/QTc studies, and blood pressure monitoring.
ECG Measurements
Thorough and Intensive QT Studies
Blood Pressure Monitoring
Medical & Scientific Expertise
ECG data delivery is a pivotal element of your cardiac safety plan. Bioclinica is a leading provider of ECG measurement services, with more than 25 years’ experience designing and conducting successful studies. We offer a range of options tailored to your compound and to the requirements of regulatory authorities.
Quality QT/QTc data is imperative in today’s competitive R&D market. Bioclinica offers a full range of support – from study design through submission – for formal thorough QT studies, and for assessing QT safety in clinical trials that cannot support traditional TQT study.
Blood pressure data is a key component of most clinical trial protocols. Whether your trial requires ambulatory or automated measures – or a combination – Bioclinica will design and implement a BP strategy tailored to the needs of your program.
Study Design and Consultative Services
In this highly dynamic and competitive business environment, it is important to have a partner that can help you successfully navigate through the complex drug development process. Whether your team is ready to conduct your company’s first TQT study, needs assistance in determining study design options and technology for defining a blood pressure signal for your protocol, or advanced training on medical imaging best practices, Bioclinica can help. We provide a full range of consultancy and reporting services supporting cardiovascular safety throughout the clinical development of your compound.
Our services include:
- Expert protocol development and study design
- Statistical analysis plans
- Expert summary reports for inclusion in the Clinical Study Report
- Regulatory guidance and support
- Charter development
Bioclinica is committed to providing you with the highest level of service. The team assigned to your cardiac safety study will provide expert advice on clinical and regulatory strategy, tailored to the framework of your program and specific compound. Engage our team of experts early to assist in developing an effective, comprehensive drug development program and trial protocol.
Cardiac Safety Analysis and Expert Reporting
Bioclinica recognizes the need to provide comprehensive services from study design and conduct to expert reporting of cardiac safety data. We possess strong capabilities in analyzing and presenting ECG/ABPM/CV data in regulatory, expert report format, and we support regulatory meetings and presentations. Our statistical and medical writing team has authored more than 250 expert reports, most of which supported regulatory submissions and full TQT protocol development.
WebHeart™ Platform
Simplify the process of managing cardiovascular data
Tracking cardiovascular safety can be a frustrating component of the drug development process. Multiple software programs for different types of data, the need to wait for periodic reports, and multi-step processes often required to review data from various sources can all hinder your ability to efficiently manage data and make rapid, informed decisions about your compound.
When you partner with Bioclinica, you gain access to WebHeart™, the comprehensive tool to seamlessly manage your cardiovascular safety data. WebHeart streamlines the management, processing, analysis, and reporting of cardiac data.
WebHeart™ is our proprietary, web-based, validated, 21 CFR part 11 compliant and configurable cardiovascular safety platform. ECG (12-lead digital ECG from standardized bedside device, extracted from 12-lead digital Holter, or direct upload from clinical pharmacology unit) and blood pressure data (ABPM, home and office BP) are centralized in WebHeart™.
Benefits of conducting your study within the WebHeart™ platform include:
- Timeliness: rapid, real-time management of study data via secure internet access. Continuous QA monitoring and reporting
- Flexibility: configurable for sponsor-specific protocols. MCC metrics based on sponsor specifications
- Compatibility: platform is device agnostic, allowing for integration of multiple ECG and BP technologies based on industry advancements
- Scalability: centralized storage of cardiovascular data for clinical trials of all sizes and scopes
- Security: multi-layered security, using a role-based, ‘rights-restricted’ model. Disaster recovery and other security considerations are built into the platform and SOPs.
- Convenience: no special software, plug-ins, or add-ons required. Provides submission-ready digital data
How we help you successfully navigate the cardiac safety component of your clinical trial:
Scientific & Regulatory Expertise
Proven expertise to plan and implement a cardiac safety strategy
Bioclinica’s experienced medical and regulatory team supports every step of your compound’s cardiovascular safety plan.
Why choose Bioclinica’s cardiac safety team?
- Cardiovascular leaders. Board-certified cardiologists who are actively involved in the Cardiac Safety Research Consortium are up to date on the best practices for successful development programs. Our team is uniquely capable of measuring blood pressure as a cardiac safety endpoint and addressing specific needs, such as the cardiovascular challenges faced by oncology trial sponsors.
- 30+ years of experience. Bioclinica has an extensive track record of designing and supporting studies that require cardiac safety monitoring.
- Ongoing relationships with regulatory authorities. Our leaders have worked with ICH, FDA, EMA, PMDA, and SFDA in the development of regulatory and industry guidelines.
Our senior executives leverage their relationships with key associations and regulatory bodies to streamline the cardiac safety regulatory process for our clients. And since 2004, we have enhanced our cardiac safety services through several key acquisitions.
Cardiac Safety Protocol Design
Effective Planning for Cardiovascular Safety
Whether your team is brainstorming Phase I strategies, getting ready for a post-Phase II FDA meeting, or preparing for submission of Phase IV results, Bioclinica can help develop and implement your cardiovascular safety strategy.
Our comprehensive services include:
- Expert protocol development and study design
- Statistical analysis plans
- Regulatory guidance and support
Your Bioclinica cardiac safety team will provide expert advice on clinical and regulatory strategy, tailored to the framework of your program and specific compound. Engage our team of experts early to help you develop an effective and comprehensive drug development program and clinical trial protocol.
Expert Cardiac Safety Analysis and Reporting
Expert reporting of cardiac safety data is key to a successful development program.
Bioclinica provides a range of reporting services:
- Expert cardiac safety analysis and reporting as a stand-alone report or for integration into the overall clinical study report
- Support for regulatory meetings and presentations
Our statistical and medical writing team has authored hundreds of expert reports, most of which supported regulatory submissions and full TQT protocol development.
