Our in-house cardiac science team optimizes clinical trial protocol design, maximizing data accuracy and reducing portfolio risks. They have worked with regulatory authorities for decades and have a thorough understanding of what methodologies and processes should be employed to ensure quality outcomes, and as a result, can guide drug development through cardiac safety regulatory requirements.
Our consulting services include:
- Expert protocol development and study design
- Statistical analysis, including concentration QTc analysis
- Authoring expert cardiac safety reports; support for Thorough QT Study waivers
- Regulatory strategy advice and support for health authority interactions
Product detail
Regulatory Consulting
Avoid safety and regulatory issues long before they become critical with strategic protocol and study design advice for early- and late-phase studies. Our consulting team can also help you determine the best devices and integrated solution and select the best strategy for analyzing cardiac endpoints.
Statistical Analysis Expertise
A team of biostatisticians and statistical programmers with expertise in cardiac safety analysis methodologies facilitate clinical trials through all phases of development.
- Developed tailored cardiac safety analysis plans designed to meet sponsor needs and study design considerations
- Expertise in the analysis of all types of cardiac safety data: QT interval data, ECG morphologic evaluations, continuous Holter / Patch arrhythmia data, 24-hour ambulatory blood pressure data, heart rate variability
- Creation of CDISC compliant analysis datasets for global regulatory submission, including electronic submission deliverable packages
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Arrhythmia Analysis
Collect continuous ECG data with certainty in site-based or decentralized clinical trials with our flexible technology solutions and patient-friendly devices.
Blood Pressure Services
Collect and centrally analyze accurate, consistent, quality blood pressure data from site-based to decentralized trials.
ECG — On-site to DCT and Phase I-IV
Monitor every heartbeat with precision from anywhere to assess safety and efficacy throughout your site-based or decentralized clinical trial.
Phase I/TQT Cardiac Assessment
Fulfill your ICH E14 requirement early, minimize risk and potentially reduce costs throughout your trial by collaborating with our Phase 1 Center of Excellence.
FAQs
What benefit do regulatory consulting services provide for study sponsors?
Regulatory consulting services provide critical strategic, technical, and operational benefits that help de-risk clinical trials, accelerate timelines, ensure compliance, and increase the likelihood of regulatory success.
The benefits can include:
- Faster trial start-up and reduced delays
- Increased probability of regulatory acceptance of the data
- Stronger clinical trial design and scientific rationale
- Improved efficiencies during the trial process
How do regulatory consultants help with clinical trial design?
Regulatory consulting plays a strategic, science-driven, and compliance-focused role in clinical trial design. The goal is to ensure that a trial is not only operationally feasible, but also aligned with regulatory expectations, statistically sound, clinically meaningful, and capable of supporting future approvals.
Consultants can help:
- Align the study design and procedures with regulatory expectations
- Design endpoints to support regulatory submission and approval
- Optimize the patient population, inclusion/exclusion criteria, and analysis plans to meet the study objectives
What are the elements of a clinical trial regulatory strategy?
A clinical trial regulatory strategy is a structured plan that aligns a product’s development path with regulatory expectations across the full lifecycle of a molecule. It defines what data is needed, when it’s needed, how it will be generated, and how the sponsor will engage with global health authorities.
How does regulatory expertise reduce trial delays or health authority inquiries?
Regulatory expertise reduces trial delays and minimizes health authority inquiries by anticipating and preempting issues before they arise. This includes designing endpoint strategies that meet agency expectations, and ensuring submissions are complete, well-justified, and scientifically sound.
Regulatory experts can help:
- Proactively identify regulatory requirements
- Align the trial with health authority expectations
- Leverage experience from previous trials and regulatory feedback
Learn more or speak with one of our experts
Our team of clinical trial cardiac solution experts is always available to address any questions you may have about our cardiac solutions. Submit your contact information and we’ll be in touch shortly.