Clinical Quality

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Clinical Quality

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

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

Medical Devices

Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects

Clinical Development

We provide clarity where there is ambiguity and find opportunities when there is uncertainty.

Clinical Operations

Our operations team have broad and deep insights in the local ethics and regulatory framework.

Biostatistics & Data Management

We appreciate data is our common currency for a range of eventualities.

Regulatory

Our regulatory team masterfully apply critical thinking when defining the regulatory strategy.

Pharmacovigilance

We provide an end-to-end pharmacovigilance solutions to our customers.