Our systems, processes and training have been developed with a quality by design approach.
Since the inception of the company we have had numerous successful audits and inspections:
We do this openly and with transparency.
Operational
Site setup/activation
Patient recruitment
Budgets
Regulatory approval(s)
Resources
Study database creation
Audit finding(s) resolution
Protocol amendments
Data
Time from patient entry to data entry
Time between patient visits and data entry
Missing data points
Impacting PEP
Impacting SEP
Protocol deviations
Major
Minor
Repetition locally, nationally, globally
Product safety – trends, reporting time compliance
Documentation
Completeness of:
TMF
ISF
Validity of study plans/essential docs:
PMP
DMP
SAP
AP
PVP
Charter(s)
Marking a significant achievement in our ongoing efforts to advance medical device research, we have successfully concluded a PMCF study…
Initiating a clinical trial is akin to embarking on a voyage of discovery in the realm of medicine. This journey,…
Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…
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