Experience
We ensure optimal cardiovascular monitoring in clinical trials.
We centralize digital and paper ECGs, Holter data, and extracted ECGs, while coordinating ABPM assessments for in-depth cardiac safety monitoring in your clinical trials.
Our focus is on regulatory support and compliance with regulatory expectations such as ICH E-14/S7B guidelines and good clinical practices. We offer operational expertise in statistical analysis, medical writing, and regulatory submissions to the FDA ECG warehouse.
We provide comprehensive and proactive cardiac safety solutions, including:
Medical experts
Our board-certified and KOL experts are supporting the project stakeholders in their day-to-day challenges
A team of Chief Medical Officers and board-certified cardiologists provides support for methodological and technical challenges.
They are easily accessible and available any time to rapidly answer your questions or questions raised by investigators and regulatory agencies.
They participate in protocol review, and the elaboration of innovative study designs and statistical plans to ensure accurate Cardiac Safety in drug development programs.
Challenges
We meet your key challenges in cardiac safety evaluation
We specialize in ensuring precise cardiac safety monitoring in clinical trials. Our expertise aligns with regulatory expectations, ensuring full compliance with international standards.
Key services include:
Project & services typologies
Our cardiac safety solutions cover a large panel of study typologies such as early and late phases, mono and multicentric
Our services include QT interval and QTc analysis (QTcB, QTcF, QTcL), Holter and event monitoring to capture continuous and episodic ECG data, and blood pressure monitoring (BPM) to assess cardiovascular risks.
Through these solutions, we ensure accurate, consistent monitoring across diverse clinical settings.
