Clinscience
43
Audits
2
EMA Inspections
4
FDA Inspections
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 setu/activation

Patient recruitment

Budgets

Regulatory approval(s)

Resources

Study database creation

Audit finding(s) resolution

Protocol amendments

Quality
Data
Documentation

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

Completeness of:

TMF

ISF

Validity of study plans/essential docs:

PMP

DMP

SAP

AP

PVP

Charter(s)

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