Clinical Quality

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Quality is at the core of everything we do.

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:

43 Audits

3 Ministry of Health Inspections

clinical quality

We collect, review and report on a broad set of metrics.

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)

Services

Newsroom

Key Considerations for Initiating a Clinical Trial: A Comprehensive Guide

Initiating a clinical trial is akin to embarking on a voyage of discovery in the realm of medicine. This journey,…

Completion of a significant clinical study

Our team at Axcellant is proud to announce the completion of a significant Post-Market Clinical Follow-up study. This study was…

Unveiling Real-World Evidence in Clinical Trials

In the ever-evolving realm of pharmaceuticals and healthcare, a remarkable transformation is afoot - one that's reshaping the way we…