Method

Metrics as Part of the Ockham Method

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 and Listings: Number of days from database lock until final tables and listings

Clinical Study Report (CSR): Number of days from database lock until final CSR.

Quality Findings: Number of Material Findings in Site Audits

Administration Metrics

Initial “CRO” Contract Negotiation: Number of revision cycles; number of days for contract revision

Scope Changes: Number of contract scope changes

Site Contract/Budget Negotiation: Number of revision cycles; number of days for contract/budget revision

Sub-Contractor (e.g., Laboratories) Contracts: Number of revision cycles; number of days for contract revision.

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

CRF Query Process: Number of days CRF reviewed to query issued; number of queries per site per page; number of days from query issued to query resolved

Monitoring Visit Reports: Number of days from monitoring visit until Monitoring Visit Report is issued

CRF Retrieval: Number of CRF pages received per week

CRF Retrieval: Number of days from subject visit to CRF in-house

Data Management Metrics

CRF Entry and Processing: Time from CRF received in-house until pages entered and processed (updated into database)

Database Lock: Number of days from last query resolved until database lock

Biostatistics Metrics

Tables and Listings: Number of days from database lock until final tables and listings.

Medical Writing Metrics

Clinical Study Report: Number of days from database lock until final CSR