Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects, ensuring we deliver exceptional, reliable services every time.
Pilot Studies: Laying a solid foundation for your medical device project.
Pivotal Studies: Robust investigations to ascertain the effectiveness and safety of your medical device.
Post-Market Clinical Follow-up (PMCF): Continuous assessment post-market to ensure ongoing safety and performance.
Registry Studies and Surveys: Extensive data collection to understand real-world performance and patient experiences.
Performance Studies: Assessing the functionality and reliability of in vitro medical devices.
PMCF: Ensuring sustained performance and safety in a real-world setting.
Successfully executed 42 medical device studies to completion, showcasing our capability to handle projects of varying complexities.
Currently steering 4 ongoing medical device studies with a hallmark of precision, ensuring each study is on track to meet its objectives.
Enrolled over 3,100 patients in medical device studies, reflecting our ability to manage large-scale studies effectively.
Demonstrated excellence through 11 audits and 2 rigorous inspections in medical device studies, underlining our commitment to adhering to the highest industry standards.
Clinical Trial Design and Management: We offer comprehensive clinical trial design and management services to ensure well-planned, executed, and monitored clinical studies.
Regulatory Submission Support: Our team provides robust support for regulatory submissions, aiding in the preparation of documentation necessary for regulatory approvals.
Data Management and Statistical Analysis: Employing state-of-the-art data management systems and statistical analysis methods to ensure accurate and reliable results.
Clinical Monitoring: Ensuring adherence to protocol and regulatory requirements through meticulous monitoring of clinical sites.
We uphold a high standard of integrity, transparency, and excellence in every aspect of our work, ensuring your medical device project is in capable hands from inception through to completion.
Discover how Axcellant can be the catalyst for your medical device project’s success. Dive deeper into our services and let’s discuss how we can support your medical device clinical studies.
Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects
We provide clarity where there is ambiguity and find opportunities when there is uncertainty.
Our operations team have broad and deep insights in the local ethics and regulatory framework.
We appreciate data is our common currency for a range of eventualities.
Our regulatory team masterfully apply critical thinking when defining the regulatory strategy.
Our systems, processes and training have been developed with a quality by design approach.