Ockham Metrics
Through Ockham’s structured assessment process, adoption of specific metrics and corresponding benchmarks form the basis for its project performance management. Although Ockham often incorporates project-specific metrics, it uses a range of standard metrics. (Please note that although detailed metrics are established for many activities, the company’s Overall Key Performance Metrics are clear drivers for a successful project.)
Overall Key Performance Metrics
- Contract Signature: Number of days from initial award to work order signature
- Sites Enrollment-Ready: Number of days from first Qualification Visit until all sites enrollment-ready
- Enrollment: Number of days from First Patient Enrolled until Last Patient Enrolled
- Database Lock: Number of days from Last Subject/Last Visit until database lock
- Tables, Listings and Figures: Number of days from database lock until final tables and listings
- Clinical Study Report (CSR): Number of days from database lock until draft CSR.
- Quality Findings: Number of Material Findings in Site Audits
Clinical-Medical Metrics
- IRB Approval: Number of days from IRB submission to IRB approval
- Sites Enrollment Ready: Number of days from Qualification Visit to site enrollment-ready
- Enrollment: Number of patients per month per site (actual versus planned)
- CRF Query Process: Turnaround time of query issued from: open to answered, answered to close and open to close; number of queries per patient/site/form
- Monitoring Visit Reports: Number of days from monitoring visit until Monitoring Visit Report is issued
- CRF Retrieval: Percent backlog of forms for entry by site versus expected forms
Data Management Metrics
- Database Lock: Number of days from last data monitored until database lock
- Database Lock: Number of days from final protocol to EDC deployment
Biostatistics Metrics
Tables, Listings and Figures: Number of days from database lock until final TLF.
Medical Writing Metrics
Clinical Study Report: Number of days from database lock until final CSR